Postprandial Glycemic ResponseNCT05587426
A Study to Investigate the Effect of SFF on Glucose and Insulin Responses
A study testing SFF, Glucose and SFF chocolate chips in people with Postprandial Glycemic Response, run by Cambridge Glycoscience at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemic Response
- What is being tested?
- SFF, Glucose and SFF chocolate chips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2022to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Glucose, and Insulin Response of Sugars From Fiber: An Acute, Double Blind, Randomized Controlled Clinical Trial
This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of:
- Sugars from Fiber in comparison with dextrose
- Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips
- Conditions
- Postprandial Glycemic Response
- Being tested
- SFF, Glucose, SFF chocolate chips, Regular chocolate chips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFFDietary supplement
Ingestion of 20g of SFF after 10-14 hours of fasting
GlucoseDietary supplement
Ingestion of 20g of glucose after 10-14 hours of fasting
SFF chocolate chipsDietary supplement
Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting
Regular chocolate chipsDietary supplement
Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting
| Study group | Role | What they receive |
|---|---|---|
| Glucose - Control | Active comparator | 20 g of glucose mixed with 250 ml of cold water Receives: Dietary Supplement: Glucose |
| SFF | Experimental | 20 g of SFF mixed with 250 ml of cold water Receives: Dietary Supplement: SFF |
| Regular chocolate chips - Control | Active comparator | 50 g of regular chocolate chips Receives: Dietary Supplement: Regular chocolate chips |
| SFF chocolate chips | Experimental | 50 g of SFF chocolate chips Receives: Dietary Supplement: SFF chocolate chips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through intervention periods of two hours
Secondary outcomes (2)
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
Measured: Through intervention periods of two hours
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
Measured: Through intervention periods of two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start3 Jun 2022
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial Glycemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Glycoscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, Ph.D, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587426
- Sponsor's protocol ID
- CG2211
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38032277
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glucose, and Insulin Response of Sugars From Fiber: An Acute, Double Blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05587426
- Acronym / sponsor ID
- CG2211
- Conditions
- Postprandial Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cambridge GlycoscienceIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of:
- Sugars from Fiber in comparison with dextrose
- Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose - Control | Active comparator | Dietary Supplement: Glucose20 g of glucose mixed with 250 ml of cold water |
| SFF | Experimental | Dietary Supplement: SFF20 g of SFF mixed with 250 ml of cold water |
| Regular chocolate chips - Control | Active comparator | Dietary Supplement: Regular chocolate chips50 g of regular chocolate chips |
| SFF chocolate chips | Experimental | Dietary Supplement: SFF chocolate chips50 g of SFF chocolate chips |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFFIngestion of 20g of SFF after 10-14 hours of fasting | Dietary supplement | SFF |
| GlucoseIngestion of 20g of glucose after 10-14 hours of fasting | Dietary supplement | Glucose - Control |
| SFF chocolate chipsIngestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting | Dietary supplement | SFF chocolate chips |
| Regular chocolate chipsIngestion of 50g of regular chocolate chips after 10-14 hours of fasting | Dietary supplement | Regular chocolate chips - Control |
Primary outcome
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
2 secondary outcomes
Plasma glucose at each time point after test meals
Time frame: Through intervention periods of two hours
Serum insulin iAUC (T0 - T120min) and each time point after test meals
Time frame: Through intervention periods of two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 38032277Moura 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.
Related trials for Postprandial Glycemic Response
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A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
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Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wolever, Ph.D principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFF, Glucose and SFF chocolate chips in people with Postprandial Glycemic Response, run by Cambridge Glycoscience at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose iAUC (T0 - T120min) after test meals (time frame: Through intervention periods of two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.