Healthy Subjects Clinical Trial
Official title:
Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
Verified date | February 2023 |
Source | University College Dublin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. It is designed as an acute, randomised, cross-over, controlled, three-arm dietary intervention trial in healthy subjects. Participants will be asked to consume either white bread, white bread with lower dose of seaweed extract or white bread with higher dose of seaweed extract.The effects on plasma glucose levels and levels of insulin will be determined over 3 hours after the consumption.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 years old - Healthy Exclusion Criteria: - Smoking - Diagnosis of any chronic illness (including diabetes, hypertension, gastrointestinal diseases etc.) - On long term prescribed medication (except contraceptives) - Pregnant or lactating - On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements) - Allergy to fruits vegetables or pollen - Unwillingness to follow dietary recommendations or record the diet during recommended period - Donated blood 4 weeks before or intend to donate blood during the study or 4 weeks after the last study samples - Participation in another research project in parallel which also involves dietary intervention (e.g. taking vitamin supplements) or requires sampling of blood |
Country | Name | City | State |
---|---|---|---|
Ireland | Institute of Food and Health Volunteer Suite; Science Center South, UCD | Dublin | Dublin 2 |
Lead Sponsor | Collaborator |
---|---|
University College Dublin |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control. | The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of both levels of seaweed extracts concomitantly with white bread, or white bread only, compared to the glucose levels before the consumption of test meals (baseline value, t=0min). | Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min | |
Secondary | Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control | The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule. | Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min | |
Secondary | Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control | nsulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals. | Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min |
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