CClinicalTrials.gg
CompletedNCT05587426Updated Oct 20, 2022

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

An interventional study of SFF and Glucose in Postprandial Glycemic Response, sponsored by Cambridge Glycoscience. Completed at 1 site in Canada. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by Cambridge Glycoscience · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Postprandial Glycemic Response
03

In context

Lead sponsor

Cambridge Glycoscience is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Glucose - Control

    20 g of glucose mixed with 250 ml of cold water

    Dietary Supplement: Glucose

  • Experimental
    SFF

    20 g of SFF mixed with 250 ml of cold water

    Dietary Supplement: SFF

  • Active comparator
    Regular chocolate chips - Control

    50 g of regular chocolate chips

    Dietary Supplement: Regular chocolate chips

  • Experimental
    SFF chocolate chips

    50 g of SFF chocolate chips

    Dietary Supplement: SFF chocolate chips

Interventions

  • Dietary supplementSFF

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

  • Dietary supplementGlucose

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

  • Dietary supplementSFF chocolate chips

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

  • Dietary supplementRegular chocolate chips

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

06

What researchers measure

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

    Time frame: Through intervention periods of two hours

Secondary outcomes

  1. Plasma glucose at each time point after test meals

    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

    Time frame: Through intervention periods of two hours

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

    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

    Time frame: Through intervention periods of two hours

07

Study locations

1 site
  • INQUIS Clinical Research, Ltd
    Toronto, Ontario M5C 2N8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05587426
Lead sponsor
Cambridge Glycoscience
Responsible party
Sponsor
First posted
Oct 20, 2022
Start date
Jun 3, 2022
Primary completion
Jul 29, 2022
Completion
Jul 29, 2022
Last update
Oct 20, 2022

Study contacts

Thomas Wolever, Ph.D
principal investigator · INQUIS Clinical Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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