A Study to Investigate the Effect of SFF on Glucose and Insulin Responses
NCT ID: NCT05587426
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-06-03
2022-07-29
Brief Summary
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1. Sugars from Fiber in comparison with dextrose
2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Glucose - Control
20 g of glucose mixed with 250 ml of cold water
Glucose
Ingestion of 20g of glucose after 10-14 hours of fasting
SFF
20 g of SFF mixed with 250 ml of cold water
SFF
Ingestion of 20g of SFF after 10-14 hours of fasting
Regular chocolate chips - Control
50 g of regular chocolate chips
Regular chocolate chips
Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting
SFF chocolate chips
50 g of SFF chocolate chips
SFF chocolate chips
Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting
Interventions
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SFF
Ingestion of 20g of SFF after 10-14 hours of fasting
Glucose
Ingestion of 20g of glucose after 10-14 hours of fasting
SFF chocolate chips
Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting
Regular chocolate chips
Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting
Eligibility Criteria
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Inclusion Criteria
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.
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.
20 Years
65 Years
ALL
Yes
Sponsors
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Cambridge Glycoscience
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Wolever, Ph.D
Role: PRINCIPAL_INVESTIGATOR
INQUIS Clinical Research
Locations
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INQUIS Clinical Research, Ltd
Toronto, Ontario, Canada
Countries
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References
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Moura de Oliveira Beltrame D, Simmons TJ, Jenkins AL, Dinan T, Nicholson TJ. Gastrointestinal Tolerability and Acute Glycemic Response of Oligosaccharides and Polysaccharides from Cellulose and Xylan in Healthy Adults: Two Double-Blinded, Randomized, Controlled, Cross-over Trials. J Am Nutr Assoc. 2024 May-Jun;43(4):305-314. doi: 10.1080/27697061.2023.2282615. Epub 2023 Nov 30.
Other Identifiers
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CG2211
Identifier Type: -
Identifier Source: org_study_id
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