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A Randomized Controlled Trial of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: Effects on Patient-Reported Outcomes.
Jeitler, M, Lauche, R, Hohmann, C, Choi, KA, Schneider, N, Steckhan, N, Rathjens, F, Anheyer, D, Paul, A, von Scheidt, C, et al
Nutrients. 2022;14(17)
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The metabolic syndrome (MetS) is a condition characterized by the presence of at least three cardiovascular risk factors, such as abdominal obesity, hypertension, insulin resistance, and dyslipidaemia. The aim of this study was to assess effects of fasting followed by the Mind-Body Medicine in Integrative and Complementary Medicine (MICOM) lifestyle modification intervention in patients with MetS on patient-reported outcomes, compared to a lifestyle modification intervention only. This study is a single-blind, bicentre, randomized controlled study. Patients (n=145) were randomly assigned in a 1:1 ratio into one of the 2 groups: fasting and lifestyle modification or the lifestyle modification. They started with 2 vegan days (max. 1200 kcal/day), followed by 5 days of fasting (max. 350 kcal/day), and a stepwise reintroduction of food. Then they participated in the 10-week MICOM comprehensive multimodal lifestyle modification intervention with weekly 6-h sessions. Results show that after the multimodal lifestyle modification intervention, there were improvements for all outcome measures, namely quality of life, anxiety, depression, stress, mood as well as self-efficacy, mindfulness, and self-compassion, which persisted at the follow-up after 24 weeks. Authors conclude that their findings show beneficial and clinically relevant effects of fasting and intensified lifestyle modification on quality of life and psychological parameters.
Expert Review
Conflicts of interest:
None
Take Home Message:
For clients with Metabolic syndrome a 5-day fast consisting of max. 350 kcal/day, in conjunction with therapies that focus on improved emotional, mental, social, spiritual, and behavioural factors may directly affect health and support improved mood.
Therapies include mindfulness and specific group training rooted in psycho-neuroendocrinology, and the use of formal meditation and gentle yoga exercises. As well as nutritional education included lectures, cooking workshops, as well as group support.
Bottom line: The use of complimentary therapies such as mindfulness, yoga and medication in conjunction with nutritional advice and may be effective to support improved mood in clients with Metabolic syndrome.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Metabolic syndrome (MetS) is a condition characterised by the presence of at least three cardiovascular risk factors such as abdominal obesity, hypertension, insulin resistance, and dyslipidemia.
The authors refer to epidemiological studies that have identified the role of psychological risk factors such as psychosocial stress, depression and anxiety in patients with MetS and cardiovascular disease.
This single-blind, bi-centre RCT assessed the effects of fasting followed by a comprehensive lifestyle modification program MICOM (Mind-Body Medicine in Integrative and Complementary Medicine) in 145 participants with Metabolic Syndrome (MetS) (62.8% women; 59.7 ± 9.3 years) randomised to:
1. 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or
2. 10 weeks of lifestyle modification only (LM; n = 72)
The study duration was 24 weeks occurring from April 2014 to December 2014, with the last follow-up assessment in December 2015. 73 Participants were randomised into an F + LM group and 72 participants into an LM group between the ages of 59 and 60.
Outcomes were assessed at weeks 0, 1, 12, and 24, for quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS).
At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups—only POMS vigour was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24.
Clinical practice applications:
This randomised controlled trial highlights fasting-induced mood-modulating effects in the short term (<24 months).
LM induced several positive effects on quality of life and psychological parameters in participants with MetS.
The compliance rate for this study was good and there were no adverse effects reported suggesting a potentially effective lifestyle modification intervention for adults with metabolic syndrome.
The authors did note the extent to which participants adhered to the program by using stress reduction techniques at home was not assessed.
Considerations for future research:
MBM lifestyle modification intervention led to an improvement of self-efficacy, mindfulness, and self-compassion.
Further studies to explore explanatory models for the effects of MBM are needed.
Mediating variables on mindfulness, self-efficacy, and compassion, and the effects on physical and psychological parameters, need to be examined more closely.
Future studies could use condition-specific questionnaires in addition to generic ones, which have previously been used to facilitate the comparison of the study results with those in the population.
Abstract
Lifestyle interventions can have a positive impact on quality of life and psychological parameters in patients with metabolic syndrome (MetS). In this randomized controlled trial, 145 participants with MetS (62.8% women; 59.7 ± 9.3 years) were randomized to (1) 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or (2) 10 weeks of lifestyle modification only (LM; n = 72). Outcomes were assessed at weeks 0, 1, 12, and 24, and included quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS). At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups-only POMS vigor was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24. Fasting can induce mood-modulating effects in the short term. LM induced several positive effects on quality of life and psychological parameters in patients with MetS.
2.
Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk.
Solomon, A, Handels, R, Wimo, A, Antikainen, R, Laatikainen, T, Levälahti, E, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of Alzheimer's disease : JAD. 2021;82(4):1461-1466
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Early identification of individuals at-risk of dementia is essential for effective preventive strategies. The aim of this study was to investigate the effect of a multidomain lifestyle intervention on the risk of dementia. This study is a post-hoc analyses of intervention effects on change in the Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score. The CAIDE score was used to select at-risk participants to the FINGER trial. FINGER is a multicentre study conducted in 6 centres in Finland. Results show a significant beneficial intervention effect, especially in women, on reducing estimated dementia risk measured by the CAIDE score. Authors conclude that CAIDE risk score can be used as a tool to communicate dementia risk, and to select persons that may benefit from lifestyle interventions.
Abstract
We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60-77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was -0.16 (95 %CI -0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04-6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.
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Daily Ingestion of Eggplant Powder Improves Blood Pressure and Psychological State in Stressed Individuals: A Randomized Placebo-Controlled Study.
Nishimura, M, Suzuki, M, Takahashi, R, Yamaguchi, S, Tsubaki, K, Fujita, T, Nishihira, J, Nakamura, K
Nutrients. 2019;11(11)
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Prevention and management of hypertension are major public health challenges worldwide. Psychosocial factors are related to blood pressure and may lead to hypertension. The aim of this study was to examine the long-term antihypertensive, anti-stress, and psychological state-improving effects of eggplant in human participants with normal-high blood pressure and grade 1 hypertension. The study is a randomized, double-blind, placebo-controlled, parallel-group comparative study. The participants were randomized into one of two intervention groups; placebo group or eggplant group. The participants ingested four eggplant powder capsules, or four placebo capsules every day for 12 weeks. Results indicate that continuous intake of eggplant powder improved blood pressure in participants with normal-high blood pressure and grade 1 hypertension. Additionally, eggplant intake improved positive and negative psychosocial states. Authors conclude that eggplant should be utilised as a safe treatment for blood pressure and mental health.
Abstract
Eggplant (Solanum melongena) is a globally popular vegetable and its significant health effect has not been reported in randomized controlled trials. Recently, we reported that eggplant was rich in choline esters, including acetylcholine (ACh), and had an antihypertensive effect in spontaneously hypertensive rats. Here, we evaluated the effects of a continuous intake of eggplant powder on blood pressure (BP), stress, and psychological state (PS) in 100 stressed participants with normal-high BP or grade 1 hypertension in a randomized, double-blind, placebo-controlled, parallel-group comparative study. The participants were randomly assigned to the eggplant or placebo group. Participants in the eggplant group ingested capsules containing eggplant powder (1.2 g/day; 2.3 mg of ACh/day) for 12 weeks, whereas participants in the placebo group ingested placebo capsules. The primary outcome assessed was hospital BP. Secondary outcomes were stress and PS. Eggplant powder intake significantly decreased the hospital diastolic blood pressure (DBP) at week 8 overall and in the normal-high BP group, and the systolic blood pressure (SBP) and DBP at week 12 overall and in the grade 1 hypertension group, compared to those of the placebo group. It also improved negative PSs at week 8 or 12 in the normal-high BP group. This is the first evidence of the BP- and PS-improving effects of eggplant intake in humans. The functional substance responsible for the effects was estimated to be eggplant-derived choline ester, namely ACh.
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A Mediterranean Diet with Fresh, Lean Pork Improves Processing Speed and Mood: Cognitive Findings from the MedPork Randomised Controlled Trial.
Wade, AT, Davis, CR, Dyer, KA, Hodgson, JM, Woodman, RJ, Keage, HAD, Murphy, KJ
Nutrients. 2019;11(7)
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Dementia is characterised by severe cognitive impairment and reduced quality of life. Observational studies have demonstrated that populations following a traditional Mediterranean diet experience less cognitive decline and a lowered risk of dementia. The aim of this study was to examine a Mediterranean diet modified to include 2–3 fresh servings of pork each week across measures of cognitive function and well-being. The study is a 24-week parallel randomised controlled crossover design to compare a Mediterranean diet with 2-3 weekly servings of fresh, lean pork (MedPork) and a low-fat control diet (LF). It recruited adults aged 45–80 years due to their increased risk of developing cardiovascular disease. Results indicate that compared with the LF control diet, the MedPork intervention led to higher performance in the cognitive domain of processing speed and higher scores for the SF-36 subscale emotional role functioning. No significant differences were observed for other domains of cognitive function, nor for additional measures of psychological well-being. Authors conclude that the MedPork intervention can improve processing speed and mood in a population at risk of cardiovascular disease and therefore dementia.
Abstract
BACKGROUND The Mediterranean diet may be capable of improving cognitive function. However, the red meat restrictions of the diet could impact long-term adherence in Western populations. The current study therefore examined the cognitive effects of a Mediterranean diet with additional red meat. METHODS A 24-week parallel crossover design compared a Mediterranean diet with 2-3 weekly servings of fresh, lean pork (MedPork) and a low-fat (LF) control diet. Thirty-five participants aged between 45 and 80 years and at risk of cardiovascular disease followed each intervention for 8 weeks, separated by an 8-week washout period. Cognitive function was assessed using the Cambridge Neuropsychological Test Automated Battery. Psychological well-being was measured through the SF-36 Health Survey and mood was measured using the Profile of Mood States (POMS). RESULTS During the MedPork intervention, participants consumed an average of 3 weekly servings of fresh pork. Compared to LF, the MedPork intervention led to higher processing speed performance (p = 0.01) and emotional role functioning (p = 0.03). No other significant differences were observed between diets. CONCLUSION Our findings indicate that a Mediterranean diet inclusive of fresh, lean pork can be adhered to by an older non-Mediterranean population while leading to positive cognitive outcomes.
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Effect of Nut Consumption on Erectile and Sexual Function in Healthy Males: A Secondary Outcome Analysis of the FERTINUTS Randomized Controlled Trial.
Salas-Huetos, A, Muralidharan, J, Galiè, S, Salas-Salvadó, J, Bulló, M
Nutrients. 2019;11(6)
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National Institutes of Health define erectile dysfunction as a persistent difficulty achieving and maintaining an erection sufficient for satisfactory sexual intercourse. The main aim of the study was to explore the effects of nuts supplementation on erectile function determined by the International Index of Erectile Function and the endothelial (inner lining of blood vessels) function. The study is a randomised controlled, two-interventions parallel, clinical trial conducted in healthy males who reported a Western-style diet. The 119 participants were randomly assigned to one of the two interventions. Results indicate that adding 60 g/d of mixed raw nuts to a Western-style diet for 14-wk improved the auto-reported orgasmic function and sexual desire parameters in a group of healthy reproductive-aged participants compared with an age-matched control group. Authors conclude that compliance with a healthy diet supplemented with mixed nuts may help to improve erectile and sexual desire.
Abstract
Lifestyle risk factors for erectile and sexual function include smoking, excessive alcohol consumption, lack of physical activity, psychological stress, and adherence to unhealthy diets. In the present study, we evaluated the effects of mixed nuts supplementation on erectile and sexual function. Eighty-three healthy male aged 18-35 with erectile function assessment were included in this FERTINUTS study sub-analysis; a 14-week randomized, controlled, parallel feeding trial. Participants were allocated to (1) the usual Western-style diet enriched with 60 g/day of a mixture of nuts (nut group; n = 43), or (2) the usual Western-style diet avoiding nuts (control group; n = 40). At baseline and the end of the intervention, participants answered 15 questions contained in the validated International Index of Erectile Function (IIEF), and peripheral levels of nitric oxide (NO) and E-selectin were measured, as surrogated markers of erectile endothelial function. Anthropometrical characteristics, and seminogram and blood biochemical parameters did not differ between intervention groups at baseline. Compared to the control group, a significant increase in the orgasmic function (p-value = 0.037) and sexual desire (p-value = 0.040) was observed during the nut intervention. No significant differences in changes between groups were shown in peripheral concentrations of NO and E-selectin. Including nuts in a regular diet significantly improved auto-reported orgasmic function and sexual desire.