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Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial.
Lehtisalo, J, Rusanen, M, Solomon, A, Antikainen, R, Laatikainen, T, Peltonen, M, Strandberg, T, Tuomilehto, J, Soininen, H, Kivipelto, M, et al
European heart journal. 2022;43(21):2054-2061
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Older people are at high risk of cardiovascular disease, and 90% of the risk factors can be modified, including an unhealthy diet, poor physical activity, obesity, smoking, and obesity-related comorbidities. This randomised controlled trial examined a multifactorial approach combining several lifestyle modifications in 1259 older adults between 60 and 77 years of age to reduce the risk of cardiovascular disease. Participants were randomly assigned to intensive multi-domain lifestyle intervention or regular health advice control groups. The multifactorial lifestyle intervention incorporated dietary counselling, exercise training, cognitive training, and managing CVD and metabolic risk factors. Dietary interventions included tailored strategies that considered increased consumption of fruits, berries, vegetables, whole grains, margarine, oil, and fish. Physical exercise interventions included strength training, balance exercises, and aerobic exercises. Cognitive interventions and intensive strategies to manage metabolic factors were also implemented. In the multifactorial lifestyle intervention group, cerebrovascular events were lower after two years than in the control group. In addition, cardiovascular disease and stroke incidence were lower in the elderly with a history of cardiovascular disease. Healthcare professionals can use the results from this study to understand the benefits of multifactorial lifestyle interventions on cardiovascular disease. However, there is a need for longer-term robust studies since the evidence is sparse.
Abstract
AIMS: Joint prevention of cardiovascular disease (CVD) and dementia could reduce the burden of both conditions. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated a beneficial effect on cognition (primary outcome) and we assessed the effect of this lifestyle intervention on incident CVD (pre-specified secondary outcome). METHODS AND RESULTS FINGER enrolled 1259 individuals aged 60-77 years (ClinicalTrials.gov NCT01041989). They were randomized (1:1) to a 2-year multi-domain intervention with diet, physical and cognitive activity, and vascular monitoring (n = 631), or general health advice (n = 628). National registries provided data on CVD including stroke, transient ischaemic attack (TIA), or coronary heart event. During an average of 7.4 years, 229 participants (18%) had at least one CVD diagnosis: 107 in the intervention group and 122 in the control group. The incidence of cerebrovascular events was lower in the intervention than the control group: hazard ratio (HR) for combined stroke/TIA was 0.71 [95% confidence interval (CI): 0.51-0.99] after adjusting for background characteristics. Hazard ratio for coronary events was 0.84 (CI: 0.56-1.26) and total CVD events 0.80 (95% CI: 0.61-1.04). Among those with history of CVD (n = 145), the incidence of both total CVD events (HR: 0.50, 95% CI: 0.28-0.90) and stroke/TIA (HR: 0.40, 95% CI: 0.20-0.81) was lower in the intervention than the control group. CONCLUSION A 2-year multi-domain lifestyle intervention among older adults was effective in preventing cerebrovascular events and also total CVD events among those who had history of CVD.
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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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Fat Quantity and Quality, as Part of a Low-Fat, Vegan Diet, Are Associated with Changes in Body Composition, Insulin Resistance, and Insulin Secretion. A 16-Week Randomized Controlled Trial.
Kahleova, H, Hlozkova, A, Fleeman, R, Fletcher, K, Holubkov, R, Barnard, ND
Nutrients. 2019;11(3)
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Dietary macronutrients play an important role in the risk of obesity and type 2 diabetes. The aim of this study was to assess the effect of diet changes on body weight and metabolism. This study is a 16-week randomized clinical trial. Adult men and women, with a body-mass index between 28 and 40 kg/m2, were enrolled. Participants were randomly assigned to the vegan or the control group and examined at baseline and 16 weeks. Results show that: - in overweight individuals, both fat quantity and quality were associated with changes in body weight, body composition, insulin resistance and insulin secretion. - decreased intake of saturated, trans, or total fat was linked to decreased fat mass. - changes in the fatty acid composition of the diet were associated with changes in insulin resistance and insulin secretion. Authors conclude that selecting foods so as to limit the intake of saturated and trans fats and increase the relative content of polyunsaturated fatty acids, may be a useful strategy for metabolic health.
Abstract
Macronutrient composition of the diet influences the development of obesity and insulin resistance. The aim of this study was to assess the role of dietary fat quantity and fatty acid composition in body composition, insulin resistance, and insulin secretion. An open parallel randomized trial design was used. Overweight participants (n = 75) were randomized to follow a low-fat vegan (n = 38) or control diet (n = 37) for 16 weeks. Dual X-ray absorptiometry was used to measure body composition. Insulin resistance was assessed with the Homeostasis Model Assessment (HOMA-IR) index. Insulin secretion was assessed after stimulation with a liquid breakfast (Boost Plus, Nestle, Vevey, Switzerland). Self-reported 3-day diet records were used to assess dietary intake. A linear regression model was used to test the relationship between fat intake and body composition, insulin resistance, and insulin secretion. Changes in fat intake expressed as percent of total energy consumed correlated positively with changes in fat mass (r = 0.52; p < 0.001; and 0.347; p = 0.006, respectively), even after adjustment for changes in body-mass index (BMI) and energy intake (0.33; p = 0.01). Decreased intakes of C18:0 (r = 0.37, p = 0.004) and CLA-trans-10-cis12 (r = 0.40, p = 0.002), but increased intake of C18:2 (r = -0.40, p = 0.002) and C18:3 (p = -0.36, p = 0.006), were associated with a decrease in HOMA-IR, independent on changes in BMI and energy intake. The main fatty acids associated with changes in fasting insulin secretion were C12:0 (r = -0.31, p = 0.03), and TRANS 16:1 (r = -0.33, p = 0.02), both independent on changes in BMI and energy intake. Our findings demonstrate that, in the context of a low-fat vegan diet, decreased intake of saturated and trans fats and increased relative content of polyunsaturated fatty acids, particularly linoleic and α-linolenic acids, are associated with decreased fat mass and insulin resistance, and enhanced insulin secretion.
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Effect of yerba mate and green tea on paraoxonase and leptin levels in patients affected by overweight or obesity and dyslipidemia: a randomized clinical trial.
Balsan, G, Pellanda, LC, Sausen, G, Galarraga, T, Zaffari, D, Pontin, B, Portal, VL
Nutrition journal. 2019;18(1):5
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Yerba mate is a popular tea-like beverage, traditionally consumed in Latin and South America. Yerba mate contains a range of plant compounds that may have beneficial effects on health, such as weight loss and antioxidant activity. This study aimed to evaluate the effect of the intake of yerba mate and green tea on serum levels of leptin, a hormone involved in regulating appetite, and paraoxonase-1 (PON-1), an enzyme that can destroy harmful oxidised fats in the blood. 142 overweight or obese adults aged 35-60 years, with abnormal levels of fats in the blood and no history of coronary artery disease took part in this controlled, randomised clinical trial. Participants drank 1 litre of either yerba mate, green tea or apple tea daily for eight weeks. Blood PON-1 and leptin levels were measured at the beginning and end of the study. The group drinking yerba mate showed a significant 9.7% increase in blood levels of PON-1, but no difference in leptin levels. The consumption of green tea resulted in no significant differences in the levels of PON-1 or leptin. The increase in PON-1 levels in the yerba mate group was significantly associated with increased levels of high-density lipoprotein (HDL-c - often called ‘good’ cholesterol). The authors concluded that drinking yerba mate increased antioxidant capacity by increasing blood levels of PON-1 and was positively associated with increased HDL-c, demonstrating a protective role of this beverage against thickening and hardening of the arteries.
Abstract
BACKGROUND This study aimed to evaluate the effect of the intake of yerba mate (YM) and green tea (GT) on serum levels of leptin and paraoxonase-1 (PON-1), compared to control. METHODS Controlled, randomized clinical trial (RCT) that evaluated 142 men and women affected by overweight or obesity aged 35-60 years, untreated dyslipidemia and no history of coronary artery disease. Participants were randomized to ingest 1000 mL GT, YM or apple tea (AT, control group) daily, during eight weeks. Serum PON-1 and leptin levels were analyzed by ELISA immunoassay at the beginning (baseline) and after eight weeks of intervention. RESULTS The intake of 1 l of YM/day resulted in significant increase in serum levels of PON-1 (9.7%; p = 0.005). The consumption of GT induced no significant difference in the levels of PON-1 (p = 0.154) and leptin (p = 0.783). Intergroup analysis showed a significant difference (p = 0.036) in the variation of PON-1 levels in the YM group when compared to GT and AT groups. In addition, the increase in PON-1 levels in the YM group was significantly associated with increased HDL-c (p = 0.004). CONCLUSIONS The intake of yerba mate increased the antioxidant capacity by increasing serum levels of PON-1 and was positively associated with increased HDL-c, stressing the protective role of this beverage against atherosclerotic diseases. GT intake had no significant effect on serum levels of PON-1 and leptin. TRIAL REGISTRATION This study is registered with ClinicalTrials.gov under protocol number NCT00933647.
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Effects of Quinoa (Chenopodium quinoa Willd.) Consumption on Markers of CVD Risk.
Li, L, Lietz, G, Bal, W, Watson, A, Morfey, B, Seal, C
Nutrients. 2018;10(6)
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Heart disease is the number one cause of death across the world. A diet high in wholegrains is often recommended as part of a heart-healthy diet, but quinoa has been less well studied in comparison to other wholegrains. The aim of this randomised, controlled, cross-over study was to evaluate the effect of daily consumption of quinoa on markers of heart disease risk. 37 healthy overweight men took part in the study. Half the group was given bread enriched with 20g of quinoa flour, whilst the other half was given bread made from 100% refined wheat flour, for 4 weeks. The groups then switched over. At the end of the study, those eating the quinoa-enriched bread saw a significant drop in blood glucose compared to the start of the study. However, there were no differences between the groups for body weight, blood pressure, blood glucose, cholesterol or inflammation. The researchers concluded that daily consumption of quinoa appears to improve blood glucose response, but has minimal effects on other markers of heart disease.
Abstract
A number of epidemiological studies have suggested that diets rich in whole grains are linked to lower cardiovascular disease (CVD) risk and mortality. Quinoa, a pseudo-cereal, is included in the “whole grain” category but the effects of quinoa consumption in humans is not widely studied. Our aim was to undertake a dietary intervention study to investigate the effects of daily consumption of quinoa-enriched bread (providing 20 g quinoa flour) on CVD risk markers compared with a 100% refined wheat bread control. Thirty-seven healthy overweight men (35⁻70 years, body mass index >25 kg/m²) completed a 4-week cross-over intervention, separated by a 4-week washout period. Fasting blood samples were collected at the beginning and end of each intervention period. Continuous glucose monitoring was undertaken at the end of each intervention period. After 4 weeks of intervention, blood glucose and low density lipoprotein (LDL) cholesterol were significantly lower than baseline in both groups but there was no difference between quinoa and control. Anthropometric measures and other blood metabolites were not different between the two treatments. The cumulative area under the blood glucose curve for the last 4 days of the quinoa intervention tended to be lower than the first 4 days of wash-out (p = 0.054), and was significantly lower than the corresponding period of the wheat treatment (p = 0.039). In conclusion, daily consumption of quinoa in this short-term intervention appears to modify glucose response, but has minimal effects on other CVD risk biomarkers.
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Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors.
Cade, WT, Reeds, DN, Mondy, KE, Overton, ET, Grassino, J, Tucker, S, Bopp, C, Laciny, E, Hubert, S, Lassa-Claxton, S, et al
HIV medicine. 2010;11(6):379-88
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People with HIV are at increased risk of developing heart disease. The aim of this prospective, randomised, controlled study was to evaluate whether yoga improves cardiovascular disease (CVD) risk factors, immune status or quality of life in adults with HIV. 60 HIV-infected adults with mild to moderate CVD risk were assigned to 20 weeks of either supervised yoga practice or standard of care treatment. Blood pressure reduced by 5 mmHg (systolic) and 3 mmHg (diastolic) in the yoga group, with a slight increase in blood pressure observed in the control group. There was an improvement in the emotional wellbeing of the yoga group compared to the control, but the difference was not statistically significant. There were no significant improvements in body weight, fat mass, blood lipids, glucose tolerance, immune markers or quality of life after yoga. The authors concluded that yoga is a lifestyle intervention that can lower blood pressure in HIV-infected adults with mild to moderate CVD risk factors.
Abstract
OBJECTIVE People living with HIV infection are at increased risk for developing cardiovascular disease (CVD). Safe and effective interventions for lowering CVD risk in HIV infection are high priorities. We conducted a prospective, randomized, controlled study to evaluate whether a yoga lifestyle intervention improves CVD risk factors, virological or immunological status, or quality of life (QOL) in HIV-infected adults relative to standard of care treatment in a matched control group. METHODS Sixty HIV-infected adults with mild-moderate CVD risk were assigned to 20 weeks of supervised yoga practice or standard of care treatment. Baseline and week 20 measures were: 2-h oral glucose tolerance test with insulin monitoring, body composition, fasting serum lipid/lipoprotein profile, resting blood pressures, CD4 T-cell count and plasma HIV RNA, and the Medical Outcomes Study Short Form (SF)-36 health-related QOL inventory. RESULTS Resting systolic and diastolic blood pressures improved more (P=0.04) in the yoga group (-5 +/- 2 and -3 +/- 1 mmHg, respectively) than in the standard of care group (+1 +/- 2 and+2 +/- 2 mmHg, respectively). However, there was no greater reduction in body weight, fat mass or proatherogenic lipids, or improvements in glucose tolerance or overall QOL after yoga. Immune and virological status was not adversely affected. CONCLUSION Among traditional lifestyle modifications, yoga is a low-cost, simple to administer, nonpharmacological, popular behavioural intervention that can lower blood pressure in pre-hypertensive HIV-infected adults with mild-moderate CVD risk factors.
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Effects of dehydroepiandrosterone (DHEA) on cardiovascular risk factors in older women with frailty characteristics.
Boxer, RS, Kleppinger, A, Brindisi, J, Feinn, R, Burleson, JA, Kenny, AM
Age and ageing. 2010;39(4):451-8
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Older women have the highest incidence of cardiovascular disease. This is thought to be partly due to declining hormone levels and changes in body composition with age. Dehydroepiandrosterone (DHEA) is a hormone that is associated with improved body composition and sense of wellbeing, and naturally declines with age. The aim of this double-blind, randomised, placebo-controlled trial was to examine the effects of DHEA supplementation on cardiovascular risk factors in older frail women. 88 women with low DHEA levels and an average age of 76 completed the 6-month study. Participants received either 50mg/day DHEA or a placebo for 6 months, along with exercise in the form of either yoga or chair aerobics. All participants also received calcium and vitamin D3 supplementation. Whilst DHEA supplementation increased the levels of sex hormones studied, cardiovascular risk factors such as abdominal fat, blood pressure, cholesterol levels and fasting glucose levels did not change. The authors concluded that short-term DHEA supplementation in older women increases levels of oestrogen and testosterone, but these changes may not have any impact on cardiovascular disease risk.
Abstract
OBJECTIVE this analysis was to investigate the effects of dehydroepiandrosterone (DHEA) on cardiovascular risk factors in older women with frailty characteristics. DESIGN, SETTING AND PARTICIPANTS the study was a double-blind, randomised, placebo-controlled trial of 99 women (mean 76.6 +/- 6.0 year) with the low DHEA-S level and frailty. INTERVENTION participants received 50 mg/day DHEA or placebo for 6 months; all received calcium (1,000-1,200 mg/day diet) and supplement (combined) and cholecalciferol (1,000 IU/day). Women participated in 90-min twice weekly exercise regimens, either chair aerobics or yoga. MAIN OUTCOME MEASURES assessment of outcome variables included hormone levels (DHEA-S, oestradiol, oestrone, testosterone and sex hormone-binding globulin (SHBG)), lipid profiles (total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides), body composition measured by dual energy absorptiometry, glucose levels and blood pressure (BP). RESULTS eighty-seven women (88%) completed 6 months of study; 88% were pre-frail demonstrating 1-2 frailty characteristics and 12% were frail with > or =3 characteristics. There were significant changes in all hormone levels including DHEA-S, oestradiol, oestrone and testosterone and a decline in SHBG levels in those taking DHEA supplements. In spite of changes in hormone levels, there were no significant changes in cardiovascular risk factors including lipid profiles, body or abdominal fat, fasting glucose or BP. CONCLUSION research to date has not shown consistent effects of DHEA on cardiovascular risk, and this study adds to the literature that short-term therapy with DHEA is safe for older women in relation to cardiovascular risk factors. This study is novel in that we recruited women with evidence of physical frailty.