A Study to Investigate the Effect of SFF on Glucose and Insulin Responses

Study Overview
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Brief Summary
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This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of: Sugars from Fiber in comparison with dextrose Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips

Official Title
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Postprandial Glucose, and Insulin Response of Sugars From Fiber: An Acute, Double Blind, Randomized Controlled Clinical Trial

Conditions
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Postprandial Glycemic Response

Intervention / Treatment
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* Dietary Supplement: SFF
* Dietary Supplement: Glucose
* Dietary Supplement: SFF chocolate chips
* Dietary Supplement: Regular chocolate chips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals, 20-65 years of age, inclusive. Body mass index (BMI) between 19 and 35 kg/m², inclusive, at screening. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. Willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial. 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. 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: Failure to meet any one of the inclusion criteria. 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. 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. Major trauma or surgical event within 3 months of screening. Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines. Known intolerance, sensitivity or allergy to test foods. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.). History of cancer in the prior two years, except for non-melanoma skin cancer. Exposure to any non-registered drug product within 30 d prior to screening. Self-reported pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose - Control<br>20 g of glucose mixed with 250 ml of cold water | Dietary Supplement: Glucose<br>* Ingestion of 20g of glucose after 10-14 hours of fasting<br>|
| Experimental: SFF<br>20 g of SFF mixed with 250 ml of cold water | Dietary Supplement: SFF<br>* Ingestion of 20g of SFF after 10-14 hours of fasting<br>|
| Active Comparator: Regular chocolate chips - Control<br>50 g of regular chocolate chips | Dietary Supplement: Regular chocolate chips<br>* Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting<br>|
| Experimental: SFF chocolate chips<br>50 g of SFF chocolate chips | Dietary Supplement: SFF chocolate chips<br>* Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose iAUC (T0 - T120min) after test meals | 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 | Through intervention periods of two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose at each time point after test meals | 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 | Through intervention periods of two hours | 
| Serum insulin iAUC (T0 - T120min) and each time point after test meals | 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 | Through intervention periods of two hours |