Omega 3 and Fibre Intervention Study to Improve Metabolic Health

NCT03442348 | Unknown

• 1 other identifier: 234186
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Disease; Immune Function; Cardiovascular Diseases; Systemic Inflammation

Keywords

Omega 3; Fibre; Gut microbiome; Metabolic profile; Dietary intervention; Randomised Control Trial

Outcome Measures

Primary Outcomes (3)

• 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

• Metabolites

  Measure of faecal metabolites such as short chain fatty acids, blood glucose, blood lipids, ketone bodies

  3-6 months

• Immune phenotypes

  Markers of immune response measured using peripheral blood mononuclear cells

  3-6 months

Secondary Outcomes (4)

• Assessment of hunger

  6 weeks

• Assessment of sleep

  6 weeks

• Assessment of physical exercise

  6 weeks

• Assessment of Mood

  6 weeks

Study Arms (2)

Omega 3 fatty acid supplements

EXPERIMENTAL

Participants in this arm (N\>32) will be required to take one 500mg capsule of Omega 3 along with a meal daily for 6 weeks.

Dietary Supplement: Omega 3 fatty acid

Inulin fibre

ACTIVE COMPARATOR

The participants in the control arm (N\>32) will be asked to take 20 g of fibre (inulin fibre) per day for a period of 6 weeks.

Dietary Supplement: Inulin fibre

Interventions

Omega 3 fatty acid DIETARY_SUPPLEMENT

Participants in the bottom median of dietary fibre intake (\<15 g per day) will be randomised into one of two arms. Participants in the second arm (N\>32) will be required to take one 500mg capsule of Omega 3 along with a meal daily for 6 weeks.

Omega 3 fatty acid supplements

Inulin fibre DIETARY_SUPPLEMENT

The participants in the control arm (N\>32) will be asked to take 20 g of fibre (resistant starch + inulin) per day that are known favour production of SCFAs in the colon for a period of 6 weeks. The inulin powder will be provided in pre-weighed sachets containing 10g each which can be taken mixed in water or a suitable beverage of choice taken twice (morning and evening) per day.

Inulin fibre

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

King's College London

London, England, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Diseases; Cardiovascular Diseases

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ana Valdez, Dr

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a randomised controlled parallel intervention study in which participants will be grouped into 2 different study arms.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: February 22, 2018
• Study Start: May 31, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

GB (1)