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Completed

NCT Number: NCT05587426

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

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INQUIS Clinical Research, Ltd

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SFF

Dietary Supplement

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

Glucose

Dietary Supplement

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

SFF chocolate chips

Dietary Supplement

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

Regular chocolate chips

Dietary Supplement

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

Primary outcomes

  1. Plasma glucose iAUC (T0 - T120min) after test meals

    Time frame: Through intervention periods of two hours

    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

Secondary outcomes

  1. Plasma glucose at each time point after test meals

    Time frame: Through intervention periods of two hours

    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

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

    Time frame: Through intervention periods of two hours

    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

Sponsors and collaborators

Lead sponsor

Cambridge Glycoscience

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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