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

Cambridge Glycoscience

Status: Completed

Conditions: Postprandial Glycemic Response

Treatments: Dietary Supplement: SFF chocolate chips; Dietary Supplement: SFF; Dietary Supplement: Glucose; Dietary Supplement: Regular chocolate chips

Study type: Interventional

Funder types: Industry

Identifiers

NCT05587426

CG2211

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups

Glucose - Control

Active Comparator group

Description:

20 g of glucose mixed with 250 ml of cold water

Treatment:

Dietary Supplement: Glucose

SFF

Experimental group

Description:

20 g of SFF mixed with 250 ml of cold water

Treatment:

Dietary Supplement: SFF

Regular chocolate chips - Control

Active Comparator group

Description:

50 g of regular chocolate chips

Treatment:

Dietary Supplement: Regular chocolate chips

SFF chocolate chips

Experimental group

Description:

50 g of SFF chocolate chips

Treatment:

Dietary Supplement: SFF chocolate chips