Cardiovascular Diseases Clinical Trial
Official title:
Utilising Omega 3 and Fibre to Improve Metabolic Health: A Proof of Concept Nutritional Intervention Study Targeting the Gut Microbiome
Verified date | July 2018 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Metabolic syndrome represents a major health burden worldwide affecting 20-30% of the population. This clustering of abnormalities that confers an increased risk of cardiovascular disease and type 2 diabetes mellitus, is the hallmark of "unhealthy" aging in longevity studies. Preventive strategies have so far failed since they have focused mainly on reducing caloric intake, ignoring the metabolic dysfunction in the aging body. The growing importance of the gut microbiota in all aspects of human health is clear, and unlike our genomes is potentially highly modifiable and tightly related to metabolic and immune efficiency, energy and fatty acid metabolism and satiety hormones. The investigators and others have reported that higher microbiome diversity correlates with significantly lower long-term risk of weight gain and metabolic syndrome. The investigators have recently shown that serum levels of omega-3 fatty acids correlate with higher microbiome diversity, and increased abundance of bacteria that produce butyrate are linked to lower inflammation of the gut. The investigators therefore propose to carry out a proof of concept nutritional intervention study in the TwinsUK cohort. The TwinsUK sample is probably the most detailed omic and phenotypic resource in the world and is ideal for this study. The mechanisms that result in improved microbiome composition and diversity will be explored in a highly focused novel interventional study hypothesizing that key fatty acid pathways are crucially involved in the link between diet, microbiome, immune phenotypes and metabolic syndrome. The specific objectives are to measure changes in gut microbiome composition in response to fibre supplementation compared to omega-3 fatty acid supplementation. The study will measure faecal metabolites relevant to fatty acid metabolism (short chain fatty acids), the abundance of microbial species linked to higher or lower inflammation and immune cell phenotypes to unravel the link between inflammation, diet and metabolic syndrome. There is a real lack of good diet intervention studies in this field and if successful this trial will pave the way to funding a wide variety of other diet intervention studies.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 20 and 39.9 kg/m2. Participants must have low habitual fibre consumption of less than 15g/day. Exclusion Criteria: - Refuse or are unable to give informed consent to participate in the study - Consume on average >15 g/day of NSP and RS (men and women) as part of their diets - Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline - Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program - Have a diagnosis of insulin dependent diabetes mellitus - Have a current or prior history of cardiovascular, cerebrovascular or peripheral vascular disease - Have clinically relevant pulmonary, gastro-intestinal, renal, metabolic, hematological, neurological, psychiatric, systemic or any acute infectious disease or signs of acute illness - Are women who are pregnant - Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS, coeliac) - Have contraindications included bulimia nervosa, substance abuse, clinically significant depression, or current psychiatric care - Have had a recent (within 3 months) of change in dose/regime or introduction of vitamin E, C or high dose vitamin D (>3000 IU), fish oil, prebiotics or probiotics. - Are vegetarian and thus unwilling to take fish oil capsules - People on anticoagulants and people with atrial fibrillation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London | England |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiome diversity | 16s sequencing will be carried out on whole stool samples to measure gut microbial diversity and composition. Stool samples collected and frozen within two hours will be assessed in greater detail for markers of microbiome function and gut health which include measuring key short-chain fatty acids using mass spectrometry. | 3-6 weeks | |
Primary | Metabolites | Measure of faecal metabolites such as short chain fatty acids, blood glucose, blood lipids, ketone bodies | 3-6 months | |
Primary | Immune phenotypes | Markers of immune response measured using peripheral blood mononuclear cells | 3-6 months | |
Secondary | Assessment of hunger | Appetite questionnaire | 6 weeks | |
Secondary | Assessment of sleep | Sleep pattern will be assessed using a validated questionnaire (Medical Outcomes Survey sleep questionnaire) at baseline, mid-intervention and the end of the intervention. | 6 weeks | |
Secondary | Assessment of physical exercise | Physical exercise will be assessed using a validated questionnaire(Sf-12) at baseline, mid-intervention and the end of the intervention. | 6 weeks | |
Secondary | Assessment of Mood | Mood will be assessed using a validated questionnaire (HADS, anxiety and depression validated questionnaire) at baseline, mid-intervention and the end of the intervention. | 6 weeks |
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