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

NCT ID: NCT05587426

Last Updated: 2022-10-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2022-07-29

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:

1. Sugars from Fiber in comparison with dextrose
2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips

Detailed Description

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Conditions

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Postprandial Glycemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Glucose - Control

20 g of glucose mixed with 250 ml of cold water

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 20g of glucose after 10-14 hours of fasting

SFF

20 g of SFF mixed with 250 ml of cold water

Group Type EXPERIMENTAL

SFF

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 20g of SFF after 10-14 hours of fasting

Regular chocolate chips - Control

50 g of regular chocolate chips

Group Type ACTIVE_COMPARATOR

Regular chocolate chips

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting

SFF chocolate chips

50 g of SFF chocolate chips

Group Type EXPERIMENTAL

SFF chocolate chips

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Glucose

Ingestion of 20g of glucose after 10-14 hours of fasting

Intervention Type DIETARY_SUPPLEMENT

SFF chocolate chips

Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting

Intervention Type DIETARY_SUPPLEMENT

Regular chocolate chips

Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge Glycoscience

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

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.

Reference Type DERIVED
PMID: 38032277 (View on PubMed)

Other Identifiers

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CG2211

Identifier Type: -

Identifier Source: org_study_id

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