Status:
UNKNOWN
Omega 3 and Fibre Intervention Study to Improve Metabolic Health
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Metabolic Disease
Immune Function
Eligibility:
All Genders
18-85 years
Phase:
NA
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 d...
Detailed Description
Diet and nutrition are key determinants of chronic disease. However, additional information is needed on which bioactive compounds and in what amounts they should be consumed to obtain a given health ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03442348
Start Date
May 31 2018
End Date
February 28 2020
Last Update
August 2 2018
Active Locations (1)
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1
King's College London
London, England, United Kingdom, SE1 7EH