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

NCT05587426 | Completed DMC

• 1 other identifier: CG2211
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Postprandial Glycemic Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasma glucose at each time point after test meals

  Through intervention periods of two hours

• Serum insulin iAUC (T0 - T120min) and each time point after test meals

  Through intervention periods of two hours

Study Arms (4)

Glucose - Control

ACTIVE COMPARATOR

20 g of glucose mixed with 250 ml of cold water

Dietary Supplement: Glucose

SFF

EXPERIMENTAL

20 g of SFF mixed with 250 ml of cold water

Dietary Supplement: SFF

Regular chocolate chips - Control

ACTIVE COMPARATOR

50 g of regular chocolate chips

Dietary Supplement: Regular chocolate chips

SFF chocolate chips

EXPERIMENTAL

50 g of SFF chocolate chips

Dietary Supplement: SFF chocolate chips

Interventions

SFF DIETARY_SUPPLEMENT

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

SFF

Glucose DIETARY_SUPPLEMENT

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

Glucose - Control

SFF chocolate chips DIETARY_SUPPLEMENT

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

SFF chocolate chips

Regular chocolate chips DIETARY_SUPPLEMENT

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

Regular chocolate chips - Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Glycoscience: lead

Study Sites (1)

INQUIS Clinical Research, Ltd

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38032277 DERIVED

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Thomas Wolever, Ph.D

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: June 3, 2022
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

CA (1)