Omega 3 and Fibre Intervention Study to Improve Metabolic Health
|ClinicalTrials.gov Identifier: NCT03442348|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : August 2, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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.|
|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|
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.
- 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.
- Metabolites [ Time Frame: 3-6 months ]Measure of faecal metabolites such as short chain fatty acids, blood glucose, blood lipids, ketone bodies
- Immune phenotypes [ Time Frame: 3-6 months ]Markers of immune response measured using peripheral blood mononuclear cells
- Assessment of hunger [ Time Frame: 6 weeks ]Appetite questionnaire
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442348
|King's College London|
|London, England, United Kingdom, SE1 7EH|
|Principal Investigator:||Ana Valdez, Dr||King's College London|