Postprandial Glycemic Response
Conditions
Brief summary
This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of: 1. Sugars from Fiber in comparison with dextrose 2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips
Interventions
DIETARY_SUPPLEMENTSFF
Ingestion of 20g of SFF after 10-14 hours of fasting
DIETARY_SUPPLEMENTGlucose
Ingestion of 20g of glucose after 10-14 hours of fasting
DIETARY_SUPPLEMENTSFF chocolate chips
Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting
DIETARY_SUPPLEMENTRegular chocolate chips
Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting
Sponsors
Cambridge Glycoscience
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals, 20-65 years of age, inclusive. 2. Body mass index (BMI) between 19 and 35 kg/m², inclusive, at screening. 3. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. 4. Willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial. 5. Willing to avoid the consumption of alcohol, unusual food intake, and unusual physical activity 24h prior to each study visit. Failure to follow will result in rescheduled visit. 6. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator.
Exclusion criteria
1. Failure to meet any one of the inclusion criteria. 2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 4. Major trauma or surgical event within 3 months of screening. 5. Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines. 6. Known intolerance, sensitivity or allergy to test foods. 7. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.). 8. History of cancer in the prior two years, except for non-melanoma skin cancer. 9. Exposure to any non-registered drug product within 30 d prior to screening. 10. Self-reported pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose iAUC (T0 - T120min) after test meals | Through intervention periods of two hours | Compare the postprandial glucose incremental area under the curve after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose at each time point after test meals | Through intervention periods of two hours | Compare the postprandial glucose levels at each time point after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips |
| Serum insulin iAUC (T0 - T120min) and each time point after test meals | Through intervention periods of two hours | Compare the postprandial insulin levels at each time and incremental area under the curve after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips |
Countries
Canada
Outcome results
None listed