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Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial.
Sayón-Orea, C, Razquin, C, Bulló, M, Corella, D, Fitó, M, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, Wärnberg, J, Martínez, JA, et al
JAMA. 2019;322(15):1486-1499
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Excess caloric intake and poor nutritional quality are associated with overweight and obesity. A traditional Mediterranean diet has been shown to reduce all-cause mortality, and in particular to reduce risk of cardiovascular disease, type 2 diabetes mellitus and overweight. The aim of this randomised, prospective, single-blinded study was to evaluate the effectiveness of an intensive lifestyle intervention programme in 6874 overweight or obese men and women with metabolic syndrome in Spain. The intervention group was advised on an energy-reduced Mediterranean diet and exercise and received behavioural support, with initial group sessions and interviews, and monthly follow-up phone calls for one year. The control group received advice on a Mediterranean diet and usual care, with 6 monthly follow-ups. After 12 months, the more intensively counselled patients showed a significantly better adherence to an energy-reduced Mediterranean diet than the control group. They had greater reductions in refined grains, pastries, red and processed meats and greater increases in vegetable, fruit and nut consumption than the control group. The intervention group had also better improvements in cardiovascular risk factors.
Abstract
Importance: High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. Interventions: Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and Measures: The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). Results: Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). Conclusions and Relevance: In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registration: isrctn.com Identifier: ISRCTN89898870.
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Dietary Fat Intake and Metabolic Syndrome in Older Adults.
Julibert, A, Bibiloni, MDM, Mateos, D, Angullo, E, Tur, JA
Nutrients. 2019;11(8)
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Metabolic syndrome (MetS) is an umbrella term for a cluster of conditions that can increase your chance of developing heart disease, type 2 diabetes and cancer. Growing evidence points to a role of the diet and nutrients in the development of MetS. This cross-sectional nutritional survey of 477 older male and female adults aimed to assess fat intake in older adults with or without MetS. The intake of many different nutrients were analysed for relationships with MetS, however of note the results showed that individuals with MetS consumed significantly higher total fat intake but lower energy, carbohydrate and fibre intake. Part of the analysis showed that hypertension is associated with lower polyunsaturated fat intake, however stomach obesity was associated with high polyunsaturated fat and vegetable fat intake. Interestingly men with MetS reported lower consumption of ready to eat meals. It was concluded that individuals with MetS are less likely to meet recommendations for fat, carbohydrate and protein consumption than those without MetS. This study could be used by clinicians to emphasise the need for individuals with MetS to consume a variety of fruits, vegetables, fish, nuts and whole grains as part of a balanced nutrient rich diet.
Abstract
BACKGROUND Metabolic Syndrome (MetS) is associated with higher rates of cardiovascular disease (CVD), type 2 diabetes mellitus, and cancer worldwide. OBJECTIVE To assess fat intake in older adults with or without MetS. DESIGN Cross-sectional nutritional survey in older adults living in the Balearic Islands (n = 477, 48% women, 55-80 years old) with no previous CVD. METHODS Assessment of fat (total fat, MUFA, PUFA, SFA, TFA, linoleic acid, α-linolenic acid, marine and non-marine ω-3 FA, animal fat and vegetable fat, cholesterol) and macronutrient intake using a validated food frequency questionnaire, and its comparison with recommendations of the US Institute of Medicine (IOM) and the Spanish Society of Community Nutrition (SENC). RESULTS Participants with MetS showed higher BMI, lower physical activity, higher total fat and MUFA intake, and lower intake of energy, carbohydrates, and fiber than participants without MetS. Men and women with MetS were below the Acceptable Macronutrient Distribution Range (AMDR) proposed by IOM for carbohydrates and above the AMDR for total fat and MUFAs, and women were below the AMDR proposed for α-linolenic acid (ALA) compared with participants without MetS. CONCLUSIONS Subjects with MetS were less likely to meet IOM and SENC recommendations for fat and macronutrient intakes as compared to non-MetS subjects.
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Nicotinamide Riboside Augments the Aged Human Skeletal Muscle NAD+ Metabolome and Induces Transcriptomic and Anti-inflammatory Signatures.
Elhassan, YS, Kluckova, K, Fletcher, RS, Schmidt, MS, Garten, A, Doig, CL, Cartwright, DM, Oakey, L, Burley, CV, Jenkinson, N, et al
Cell reports. 2019;28(7):1717-1728.e6
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As the body ages, there is a decline in muscle mass and function, which can be combatted with diet, exercise, and supplementation. Nicotinamide riboside (NR) or vitamin B3 has been shown in animal studies to promote healthy muscle, however its effects in human muscle are unknown. This randomised control trial of overweight older men aimed to determine if NR can be used by muscle and whether it has any effect on muscle function. The results showed that NR supplementation (1 g/day) for 3 weeks can be used by the muscle but had no effect on muscle function as shown by the hand grip test. Supplementation also decreased energy production in muscle and had anti-inflammatory effects. It was concluded that NR is available to muscle and that it may have anti-inflammatory properties, which may be of benefit to older individuals.
Abstract
Nicotinamide adenine dinucleotide (NAD+) is modulated by conditions of metabolic stress and has been reported to decline with aging in preclinical models, but human data are sparse. Nicotinamide riboside (NR) supplementation ameliorates metabolic dysfunction in rodents. We aimed to establish whether oral NR supplementation in aged participants can increase the skeletal muscle NAD+ metabolome and if it can alter muscle mitochondrial bioenergetics. We supplemented 12 aged men with 1 g NR per day for 21 days in a placebo-controlled, randomized, double-blind, crossover trial. Targeted metabolomics showed that NR elevated the muscle NAD+ metabolome, evident by increased nicotinic acid adenine dinucleotide and nicotinamide clearance products. Muscle RNA sequencing revealed NR-mediated downregulation of energy metabolism and mitochondria pathways, without altering mitochondrial bioenergetics. NR also depressed levels of circulating inflammatory cytokines. Our data establish that oral NR is available to aged human muscle and identify anti-inflammatory effects of NR.
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A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia.
Upadya, H, Prabhu, S, Prasad, A, Subramanian, D, Gupta, S, Goel, A
BMC complementary and alternative medicine. 2019;19(1):27
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Emblica officinalis (Amla or Indian gooseberry) is a fruit that has been traditionally used in Ayurvedic medicine. It has been shown to be effective in the management of dyslipidemia (abnormal fat metabolism), a risk factor for heart disease, in animal models and in pilot clinical studies without major side effects. This multicenter, randomised, placebo controlled, double blind clinical trial was designed to evaluate the efficacy and safety of a proprietary full spectrum amla extract (containing pulp and seeds) in patients with dyslipidemia. 98 patients were enrolled and all completed the 12 week study. None of them were taking any medication for their dyslipidaemia. All the patients enrolled in the study were also asked to initiate lifestyle changes (healthy diet with exercise at least 4 days a week). Apart from conventional lipid parameters, the investigators also measured a number of other parameters relevant to heart disease, including the atherogenic index of plasma (AIP, a marker of heart disease risk). Compared to the placebo group the amla group had significantly greater reductions in triglycerides, LDL-cholesterol, VLDL-cholesterol and the atherogenic index of plasma (AIP, a better predictor of heart disease risk). There were no significant changes in HDL-cholesterol, CoQ10 (lowering of CoQ10 is a concern with many cholesterol lowering drugs), homocysteine, thyroid stimulating hormone (TSH) or fasting blood glucose. Four non-serious adverse events were observed: mild headache, mild fever, two times gastritis (all resolved with standard treatment), three were in the placebo group, one in the amla group. There were no changes in routine blood tests and vital signs (blood pressure, heart rate, temperature, respiratory rate). The authors conclude that the amla extract has significant potential to improve dyslipidaemia without side effects commonly seen with cholesterol lowering drugs.
Abstract
BACKGROUND Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. METHODS A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). RESULTS In 12 weeks, the major lipids such as total cholesterol (TC) (p = 0.0003), triglyceride (TG) (p = 0.0003), low density lipoprotein cholesterol (LDL-C) (p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p = 0.2942) or placebo groups (p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. CONCLUSIONS The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins. TRIAL REGISTRATION Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682 ) on 8 April 2015 (retrospectively registered).
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Association of the Functional Medicine Model of Care With Patient-Reported Health-Related Quality-of-Life Outcomes.
Beidelschies, M, Alejandro-Rodriguez, M, Ji, X, Lapin, B, Hanaway, P, Rothberg, MB
JAMA network open. 2019;2(10):e1914017
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The functional medicine model of care provides an operating system that works to reverse illness, promote health, and optimize function by addressing underlying causes, symptoms, and functional imbalances in interconnected biological networks. The aim of this study was to investigate the association between the functional medicine model of care and health-related quality of life (HRQoL) by comparing functional medicine with care received in a family medicine setting. The study is a single-centre retrospective cohort study which recruited 7252 new patients. The study evaluated the association of HRQoL in patients receiving functional medicine care vs patients receiving primary care. Results indicate that clients seen at the Centre for Functional Medicine were more likely to experience a clinically meaningful change in their (patient-reported outcome measurement information system and global physical health) scores at 6 months, which was less likely to decrease over time. Authors conclude that the functional medicine model of care may have beneficial and sustainable associations with improved HRQoL in patients as measured by patient-reported outcome measurement information system, global physical health and global mental health scores.
Abstract
Importance: The incidence of chronic disease is increasing along with health care-related costs. The functional medicine model of care provides a unique operating system to reverse illness, promote health, and optimize function. The association between this model of care and patient's health-related quality of life (HRQoL) is unknown. Objective: To assess the association between functional medicine and patient-reported HRQoL using Patient-Reported Outcome Measurement Information System (PROMIS) global health measures. Design, Setting, and Participants: A retrospective cohort study was performed to compare 7252 patients aged 18 years or older treated in a functional medicine setting with propensity score (PS)-matched patients in a primary care setting. Sensitivity analyses assessed improvement limited to patients seen at both 6 and 12 months. The study included patients who visited the Cleveland Clinic Center for Functional Medicine or a Cleveland Clinic family health center between April 1, 2015, and March 1, 2017. Main Outcomes and Measures: The primary outcome was change in PROMIS Global Physical Health (GPH) at 6 months. Secondary outcomes included PROMIS Global Mental Health (GMH) at 6 months and PROMIS GPH and GMH at 12 months. The PROMIS GPH and GMH scores were transformed to a T-score from 0 to 100 with a mean of 50. Higher scores indicate a better health-related quality of life. Results: Of the 7252 patients (functional medicine center: 1595; family health center: 5657), 4780 (65.9%) were women; mean (SD) age was 54.1 (16.0) years. At 6 months, functional medicine patients exhibited significantly larger improvements in PROMIS GPH T-score points than were seen in patients treated at a family health center (mean [SD] change, functional medicine center: 1.59 [6.29] vs family health center: 0.33 [6.09], P = .004 in 398 PS-matched pairs). At 12 months, functional medicine patients showed improvement similar to that observed at 6 months; however, comparisons with patients seen at the family health center were not significant. Patients in the functional medicine center with data at both 6 and 12 months demonstrated improvements in PROMIS GPH (mean [SD], 2.61 [6.53]) that were significantly larger compared with patients seen at a family health center (mean [SD], 0.25 [6.54]) (P = .02 in 91 PS-matched pairs). Conclusions and Relevance: In this study, the functional medicine model of care demonstrated beneficial and sustainable associations with patient-reported HRQoL. Prospective studies are warranted to confirm these findings.
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Comparison of the Effects of Fasting Glucose, Hemoglobin A1c, and Triglyceride-Glucose Index on Cardiovascular Events in Type 2 Diabetes Mellitus.
Su, WY, Chen, SC, Huang, YT, Huang, JC, Wu, PY, Hsu, WH, Lee, MY
Nutrients. 2019;11(11)
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Cardiovascular disease generally refers to the narrowing or blockage of the arteries of the heart, which can lead to a heart attack or stroke and is the major cause of death in individuals with type 2 diabetes. Identifying individuals with type 2 diabetes who are at high risk of developing cardiovascular disease could ensure better management of these patients. This retrospective observational study of 3524 individuals with type 2 diabetes aimed to investigate if the amount of sugar found in the blood over the last few months, known as haemaglobin A1c (HbA1c) can predict cardiovascular disease in individuals with type 2 diabetes. In addition, the study looked at the triglyceride-glucose (TyG) index and its relationship to cardiovascular disease outcomes. The results showed that several factors were associated with cardiovascular disease, however of main note was that the TyG index and the amount of sugar in the blood following a fast were associated with increased cardiovascular events in individuals with type 2 diabetes, but HbA1c was not. It was concluded that TyG and the blood sugar level could be used to allow early identification and management of type 2 diabetics to prevent cardiovascular events. Clinicians could use this study to justify the use of measuring the TyG index and blood sugar levels as a predictor for cardiovascular events to ensure that patients are managed not only for type 2 diabetes but also to reduce their risk of cardiovascular events in the future.
Abstract
The triglyceride-glucose (TyG) index has been correlated with insulin resistance. We aim to investigate the role of the TyG index on cardiovascular (CV) events in type 2 diabetes mellitus and compare the roles of fasting glucose, hemoglobin A1c, and the TyG index in predicting CV events. This retrospective study enrolled 3524 patients with type 2 diabetes from the Kaohsiung Medical University Research Database in 2009 in this longitudinal study and followed them until 2015. The TyG index was calculated as log (fasting triglyceride level (mg/dL) × fasting glucose level (mg/dL)/2). CV events included myocardial infarction, unstable angina, stroke, hospitalization for coronary artery disease, peripheral artery disease, and CV-related death. The association between variables and CV events was assessed using a multivariable stepwise Cox proportional hazard analysis. Two hundred and fifteen CV events (6.1%) were recorded during a follow-up period of 5.93 years. The multivariable stepwise analysis showed that high fasting glucose (HR, 1.007; p < 0.001) and a high TyG index (HR, 1.521; p = 0.004) but not hemoglobin A1c or triglycerides were associated with a higher rate of CV events. Adding fasting glucose and the TyG index to the basic model improved the predictive ability of progression to a CV event (p < 0.001 and p = 0.018, respectively), over that of hemoglobin A1c (p = 0.084) and triglyceride (p = 0.221). Fasting glucose and the TyG index are useful parameters and stronger predictive factors than hemoglobin A1c and triglyceride for CV events and may offer an additional prognostic benefit in patients with type 2 diabetes.
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Adherence to the Mediterranean Diet and Its Association with Body Composition and Physical Fitness in Spanish University Students.
Cobo-Cuenca, AI, Garrido-Miguel, M, Soriano-Cano, A, Ferri-Morales, A, Martínez-Vizcaíno, V, Martín-Espinosa, NM
Nutrients. 2019;11(11)
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The Mediterranean diet (MD) represents a dietary pattern that incorporates healthy traditional eating habits which includes high consumption of vegetables, fruit, legumes, nuts, beans, whole grains, fish, and unsaturated fats, and low consumption of red meat and dairy products. The Mediterranean Diet Adherence Screener (MEDAS-14 items) is a valid instrument for the estimation of adherence to the MD. The objectives of this study were to: 1. Estimate the prevalence of the adherence to the MD 2. Assess the association of adherence to the MD with physical fitness and body composition 3. Know the ability of each MEDAS item in the same sample to predict MD adherence. This study is a cross-sectional observational study which was performed with 310 first-year Spanish university students, aged between 18 and 30 years. Results indicate low prevalence of good adherence to the MD; and the participants with good adherence had high protein and low-fat intake compared to those with medium to low adherence. Furthermore, higher levels of physical fitness were also noticed amongst participants with good adherence to the MD. Twelve of the 14 items of the MEDAS score were associated with a high adherence to the MD. Authors conclude that MD adherence benefits both cardiorespiratory and muscular fitness amongst young adults.
Abstract
The aims of this study were to assess the association of adherence to the Mediterranean diet (MD) with physical fitness and body composition in Spanish university students and to determine the ability to predict the MD adherence of each Mediterranean Diet Adherence Screener (MEDAS) item. A cross-sectional study was performed involving 310 first-year university students. Adherence to the MD was evaluated with MEDAS-14 items. Anthropometric variables, body composition, and physical fitness were assessed. Muscle strength was determined based on handgrip strength and the standing long jump test. Cardiorespiratory fitness (CRF) was measured using the Course-Navette test. Only 24% of the university students had good adherence to the MD. The ANCOVA models showed a significant difference between participants with high adherence to the MD and those with medium and low adherence in CRF (p = 0.017) and dynamometry (p = 0.005). Logistic binary regression showed that consuming >2 vegetables/day (OR = 20.1; CI: 10.1-30.1; p < 0.001), using olive oil (OR = 10.6; CI: 1.4-19.8; p = 0.021), consuming <3 commercial sweets/week (OR = 10.1; IC: 5.1-19.7; p < 0.001), and consuming ≥3 fruits/day (OR = 8.8; CI: 4.9-15.7; p < 0.001) were the items most associated with high adherence to the MD. In conclusion, a high level of adherence to the MD is associated with high-level muscular fitness and CRF in Spanish university students.
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A pilot, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee.
Majeed, M, Majeed, S, Narayanan, NK, Nagabhushanam, K
Phytotherapy research : PTR. 2019;33(5):1457-1468
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Osteoarthritis (OA) is an age-related, degenerative joint disorder which affects many people worldwide. It causes pain, most frequently in the large joints such as knee and hips and is characterised by pain, decreased mobility and negative effects on the quality of life. This randomised, double-blind placebo controlled trial of 48 adults between the age of 35 and 75, aimed to evaluate the safety and efficacy of Boswellia serrata extract on newly diagnosed or untreated patients with OA of the knee. 340mg of Boswellia serrata extract was administered daily in 2 doses to the treatment group for 120 days. Outcome measures were WOMAC scores on pain, stiffness and physical function; a 6 min walk test assessing distance; physician assessment of range of motion, strength, stability and tenderness; x-ray images of joint space and growths; and hs-CRP, a blood marker of inflammation. The researchers found that the treatment group significantly improved, with reduced pain and stiffness compared to placebo. X-ray assessment also showed significantly improved knee join space and reductions in abnormal bone spur growth in the treatment group. Additionally, the treatment group had significantly lower hs-CRP compared to placebo. No adverse effects were reported. Whilst this is a small trial, Nutrition Practitioners working with patients with OA could consider the use of Boswellia serrata extract in their supplement protocols.
Abstract
A double-blind, placebo-controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3-acetyl-11-keto-β-boswellic acid (AKBBA) with β-boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high-sensitive C-reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti-inflammatory/anti-arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.
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The effect of an exercise program in pregnancy on vitamin D status among healthy, pregnant Norwegian women: a randomized controlled trial.
Gustafsson, MK, Romundstad, PR, Stafne, SN, Helvik, AS, Stunes, AK, Mørkved, S, Salvesen, KÅ, Thorsby, PM, Mosti, MP, Syversen, U
BMC pregnancy and childbirth. 2019;19(1):76
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Pregnancy represents a unique metabolic state with adaptive physiological changes including the vitamin D endocrine system. The aim of this study was to explore a potential relation between regular exercise in pregnancy and the vitamin D endocrine system. This study is a two-armed, two-centre randomised controlled study. The health effects of a 12-week exercise program during pregnancy (pregnant women n = 855) was compared with standard prenatal care. Results show higher levels of total, free and bioavailable Vitamin D in the exercise group indicating that exercise in pregnancy may affect vitamin D status positively. Authors conclude by highlighting that women with uncomplicated pregnancies should be encouraged to perform regular exercise.
Abstract
BACKGROUND Vitamin D insufficiency is common in pregnant women worldwide. Regular prenatal exercise is considered beneficial for maternal and fetal health. There is a knowledge gap regarding the impact of prenatal exercise on maternal vitamin D levels. The objective of this study was to investigate whether a prenatal exercise program influenced serum levels of total, free and bioavailable 25-hydroxyvitamin D (25(OH)D) and related parameters. This is a post hoc analysis of a randomized controlled trial with gestational diabetes as the primary outcome. METHODS Healthy, pregnant women from two Norwegian cities (Trondheim and Stavanger) were randomly assigned to a 12-week moderate-intensity exercise program (Borg perceived rating scale 13-14) or standard prenatal care. The intervention group (n = 429) underwent exercise at least three times weekly; one supervised group training and two home based sessions. The controls (n = 426) received standard prenatal care, and exercising was not denied. Training diaries and group training was used to promote compliance and evaluate adherence. Serum levels of 25(OH)D, parathyroid hormone, calcium, phosphate, magnesium and vitamin D-binding protein were measured before (18-22 weeks' gestation) and after the intervention (32-36 weeks' gestation). Free and bioavailable 25(OH)D concentrations were calculated. Regression analysis of covariance (ANCOVA) was applied to assess the effect of the training regime on each substance with pre-intervention levels as covariates. In a second model, we also adjusted for study site and sampling month. Intention-to-treat principle was used. RESULTS A total of 724 women completed the study. No between-group difference in serum 25(OH)D and related parameters was identified by ANCOVA using baseline serum levels as covariates. The second model revealed a between-group difference in levels of 25(OH)D (1.9, 95% CI 0.0 to 3.8 nmol/L; p = 0.048), free 25(OH)D (0.55, 95% CI 0.10 to 0.99 pmol/L; p = 0.017) and bioavailable 25(OH)D (0.15 95% CI 0.01 to 0.29 nmol/L; p = 0.036). No serious adverse events related to regular exercise were seen. CONCLUSION This study, a post hoc analysis, indicates that exercise may affect vitamin D status positively, and emphasizes that women with uncomplicated pregnancies should be encouraged to perform regular exercise. TRIAL REGISTRATION ClinicalTrials.gov: NCT00476567 , registered May 22, 2007.
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Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial.
Gouzi, F, Maury, J, Héraud, N, Molinari, N, Bertet, H, Ayoub, B, Blaquière, M, Bughin, F, De Rigal, P, Poulain, M, et al
Oxidative medicine and cellular longevity. 2019;2019:5496346
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Chronic obstructive pulmonary disease (COPD) is systematically associated with comorbidities. Muscle atrophy and weakness are therefore targets of exercise training interventions in pulmonary rehabilitation (PR). The aim of the study was to test the effects of oral antioxidant supplementation with vitamins and trace elements (i.e. vitamins C and E, zinc and selenium) versus placebo on muscle endurance (primary outcome) and muscle strength, oxidative stress, inflammation, and PR outcomes (secondary outcomes). The study is a randomized double-blind controlled trial during PR. COPD patients (aged between 40 and 78 years) were randomly assigned to the PR antioxidant group or to the PR placebo group. Results indicate that nutritional antioxidant supplementation (vitamins C and E, zinc, and selenium) failed to further improve the patients’ quadriceps endurance. However, results also demonstrate that additional improvements of three secondary outcomes and a trend toward increased muscle type I fiber proportion with supplementation versus placebo during PR. Authors conclude that efficient antioxidant supplementation results in greater improvement in muscle function when compared to placebo in combination with exercise training.
Abstract
BACKGROUND Skeletal muscle dysfunction in patients with chronic obstructive pulmonary disease (COPD) is not fully reversed by exercise training. Antioxidants are critical for muscle homeostasis and adaptation to training. However, COPD patients experience antioxidant deficits that worsen after training and might impact their muscle response to training. Nutritional antioxidant supplementation in combination with pulmonary rehabilitation (PR) would further improve muscle function, oxidative stress, and PR outcomes in COPD patients. METHODS Sixty-four COPD patients admitted to inpatient PR were randomized to receive 28 days of oral antioxidant supplementation targeting the previously observed deficits (PR antioxidant group; α-tocopherol: 30 mg/day, ascorbate: 180 mg/day, zinc gluconate: 15 mg/day, selenomethionine: 50 μg/day) or placebo (PR placebo group). PR consisted of 24 sessions of moderate-intensity exercise training. Changes in muscle endurance (primary outcome), oxidative stress, and PR outcomes were assessed. RESULTS Eighty-one percent of the patients (FEV1 = 58.9 ± 20.0%pred) showed at least one nutritional antioxidant deficit. Training improved muscle endurance in the PR placebo group (+37.4 ± 45.1%, p < 0.001), without additional increase in the PR antioxidant group (-6.6 ± 11.3%; p = 0.56). Nevertheless, supplementation increased the α-tocopherol/γ-tocopherol ratio and selenium (+58 ± 20%, p < 0.001, and +16 ± 5%, p < 0.01, respectively), muscle strength (+11 ± 3%, p < 0.001), and serum total proteins (+7 ± 2%, p < 0.001), and it tended to increase the type I fiber proportion (+32 ± 17%, p = 0.07). The prevalence of muscle weakness decreased in the PR antioxidant group only, from 30.0 to 10.7% (p < 0.05). CONCLUSIONS While the primary outcome was not significantly improved, COPD patients demonstrate significant improvements of secondary outcomes (muscle strength and other training-refractory outcomes), suggesting a potential "add-on" effect of the nutritional antioxidant supplementation (vitamins C and E, zinc, and selenium) during PR. This trial is registered with NCT01942889.