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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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Plain language summary
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.
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A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT.
Fortier, M, Castellano, CA, St-Pierre, V, Myette-Côté, É, Langlois, F, Roy, M, Morin, MC, Bocti, C, Fulop, T, Godin, JP, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2021;17(3):543-552
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Brain energy rescue is emerging as a potential strategy to reduce cognitive decline in mild cognitive impairment (MCI) and Alzheimer’s disease (AD). The main aim of this study was to report the complete cognitive outcomes of the BENEFIC (Brain Energy, Functional Imaging, and Cognition) trial. The secondary objectives are to report plasma ketones (free caprylic and capric acids) levels; as well as the metabolic response, safety, and tolerability after the 6-month intervention. This study is a 6-month randomised, placebo-controlled trial. A total of 122 participants were enrolled and randomised into one of the two arms: ketogenic medium chain triglyceride (kMCT) or placebo arm. Results show that performance on widely used tests of episodic memory, executive function, and language improved over 6 months in MCI when consuming 30g/day of a kMCT drink relative to a matching placebo. Moderate to large effect sizes were observed on four cognitive tests in the kMCT group. Furthermore, it is safe and feasible for an MCI population to consume a 15g kMCT supplement twice daily for 6 months. Authors conclude that formulation of a kMCT drink improved four cognitive outcomes in MCI by increasing blood ketone levels.
Expert Review
Conflicts of interest:
None
Take Home Message:
- MCT supplementation is a promising strategy to rescue energy metabolism in the brain for those with MCIs by providing an alternative energy source
- Improvements in cognition were associated with increased blood ketone levels from MCT supplementation
- Practitioners should be mindful that higher intakes of MCTs (>30g/d) may lead to negative GI effects in some individuals.
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:
This randomized controlled trial demonstrates that supplementation of a ketogenic drink containing medium-chain triglycerides (MCTs) is both safe and effective in improving cognitive outcomes in individuals with mild cognitive impairments (MCI), and does so through supporting energy metabolism in the brain.
Clinical practice applications:
These findings might be useful for Nutritional Therapists and Clinical Practitioners as follows:
- The results of this randomised controlled trial demonstrate that MCT supplementation (at 30g per day, split between two doses) is a viable strategy to support brain metabolism in individuals experiencing MCIs
- There was a dose-dependant response on elevated ketones and selected cognitive improvements which may have pertinent applications to therapeutic practice (either dietary or supplemental)
- The paper highlighted the involvement of energy metabolism in cognitive decline; this has potential therapeutic applications in terms of targeted nutritional support for mitochondrial function or energy signalling
- Some individuals experienced negative gastrointestinal effects when consuming MCTs at 30g/d for prolonged periods; practitioners should be mindful of this.
Considerations for future research:
Future research should consider:
- Whether dietary-induced ketosis can therapeutically impact MCI and support patient well-being
- Use of MCTs in those with severe cognitive impairments or those taking medication such as cholinesterase inhibitors
the role of glucose hypometabolism to determine alternative strategies for those who have GI issues with MCTs
- Whether APOE4 status has any impact on therapeutic outcomes to MCT supplementation
- Whether adjunct nutritional support for mitochondrial function alongside MCT could further impact on MCIs.
Abstract
INTRODUCTION Counteracting impaired brain glucose metabolism with ketones may improve cognition in mild cognitive impairment (MCI). METHODS Cognition, plasma ketone response, and metabolic profile were assessed before and 6 months after supplementation with a ketogenic drink containing medium chain triglyceride (ketogenic medium chain triglyceride [kMCT]; 15 g twice/day; n = 39) or placebo (n = 44). RESULTS Free and cued recall (Trial 1; P = .047), verbal fluency (categories; P = .024), Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates). Some cognitive outcomes also correlated positively with plasma ketones. Plasma metabolic profile and ketone response were unchanged. CONCLUSIONS This kMCT drink improved cognitive outcomes in MCI, at least in part by increasing blood ketone level. These data support further assessment of MCI progression to Alzheimer's disease.