Status:
COMPLETED
Seaweed Extract Supplementation and Metabolic Biomarkers
Lead Sponsor:
BioAtlantis Ltd.
Collaborating Sponsors:
University of Roehampton
Conditions:
Metabolic Syndrome
Insulin Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Double blinded, randomized, placebo controlled preliminary pilot exploratory investigation into the effects of brown seaweed extract supplementation, on fasting blood Insulin, fasting blood glucose, i...
Detailed Description
Diabetes melitus is a group of metabolic disorders resulting from a defect in insulin production and/or insulin action. The World Health Organisation (WHO) has estimated that the total number of peopl...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) 25-35 kg/m2
- Not dieting within the last month and not having lost \>5% body weight in the previous year
- Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
- Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
- Able to eat most everyday foods
- Habitually consumes three standard meals a day
Exclusion
- Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
- Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
- BMI \<25 kg/m2 or \>35 kg/m2
- Volunteers self-reporting currently dieting or having lost \>5% body weight in the previous year
- Participants with abnormal eating behaviour
- Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
- Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
- Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
- Participants on specific food avoidance diets
- Participants who work in appetite or feeding related areas
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03853343
Start Date
June 28 2018
End Date
January 30 2022
Last Update
March 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roehampton University
London, United Kingdom, SW15 5PJ