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Omega 3 and Fibre Intervention Study to Improve Metabolic Health

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ClinicalTrials.gov Identifier: NCT03442348
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Metabolic Disease Immune Function Cardiovascular Diseases Systemic Inflammation Dietary Supplement: Omega 3 fatty acid Dietary Supplement: Inulin fibre Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a randomised controlled parallel intervention study in which participants will be grouped into 2 different study arms.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Utilising Omega 3 and Fibre to Improve Metabolic Health: A Proof of Concept Nutritional Intervention Study Targeting the Gut Microbiome
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Omega 3 fatty acid supplements
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
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.

Active Comparator: Inulin fibre
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
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.




Primary Outcome Measures :
  1. Gut microbiome diversity [ Time Frame: 3-6 weeks ]
    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.

  2. Metabolites [ Time Frame: 3-6 months ]
    Measure of faecal metabolites such as short chain fatty acids, blood glucose, blood lipids, ketone bodies

  3. Immune phenotypes [ Time Frame: 3-6 months ]
    Markers of immune response measured using peripheral blood mononuclear cells


Secondary Outcome Measures :
  1. Assessment of hunger [ Time Frame: 6 weeks ]
    Appetite questionnaire

  2. Assessment of sleep [ Time Frame: 6 weeks ]
    Sleep pattern will be assessed using a validated questionnaire (Medical Outcomes Survey sleep questionnaire) at baseline, mid-intervention and the end of the intervention.

  3. Assessment of physical exercise [ Time Frame: 6 weeks ]
    Physical exercise will be assessed using a validated questionnaire(Sf-12) at baseline, mid-intervention and the end of the intervention.

  4. Assessment of Mood [ Time Frame: 6 weeks ]
    Mood will be assessed using a validated questionnaire (HADS, anxiety and depression validated questionnaire) at baseline, mid-intervention and the end of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442348


Locations
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United Kingdom
King's College London
London, England, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Ana Valdez, Dr King's College London

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03442348     History of Changes
Other Study ID Numbers: 234186
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Omega 3
Fibre
Gut microbiome
Metabolic profile
Dietary intervention
Randomised Control Trial

Additional relevant MeSH terms:
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Inflammation
Cardiovascular Diseases
Metabolic Diseases
Pathologic Processes