Blood Glucose KineticsNCT02323542
Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers
A study testing Nutrition intervention with cereal products in people with Blood Glucose Kinetics, run by Mondelēz International, Inc. at 1 site in Canada.
Trial summary
The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Kinetics
- What is being tested?
- Nutrition intervention with cereal products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2016
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer, male or female (half male, half female);
- Aged between 18 and 40 years old (bounds included);
- Non-smoker;
- BMI ranging between 18.5 and 25 kg/m2 (bounds included)
- Waist circumference ≤ 94 cm for men and ≤ 80 cm for women;
- Stable body weight (± 1 kg) over the 3 months preceding the experimental period;
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- Systolic blood pressure between 95 and 145 mmHg and diastolic blood pressure between 50 and 85 mmHg;
- For the female subjects: use of an oral contraceptive with regular menstrual cycles;
- Subject not displaying any identified significant metabolic impairment according to the Principal Investigator;
- Sedentary or with a moderate physical activity;
- Not having given blood in the month prior to the selection and accepting not to give blood during the experimental period of the present study;
- Regularly consuming a breakfast providing more than 15% of the total daily energy intake, including at least one cereal product; adequate partitioning of macronutrient intake;
- Providing written consent for his/her participation to the study;
Who cannot join
- Subject with a severe or acute disease which should influence the results of the study and to be life-threatening for the volunteer according to the Principal Investigator;
- Subject with medical history of symptomatic vascular diseases (infarct, angina pectoris, syndrome of threat, surgery or endovascular surgery, stroke, symptomatic peripheral arteritis) which according to the investigator should interfere with the results from the study or should constitute a particular risk for the subject;
- Subject with type 1 or type 2 diabetes;
- Subject with any food allergy;
- Subject with eating disorders (e.g. anorexia nervosa \& bulimia) according to the Principal Investigator;
- Subject regularly consuming more than 20 g/day of alcohol;
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- Subject regularly consuming recreational drugs;
- Subject consuming regularly corticoids, anorectics, adrenergic drugs, gastric demulcent, cholesterol and/or lipid lowering medication, weight-loss drugs or other drugs or supplement that should impact glucose metabolism in the Principal Investigator's opinion;
- Pregnant or lactating women;
- Currently participating in another study or having participated in another study in the 3 months prior to the selection visit;
- Consuming large amounts of food products naturally rich in 13C.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2W1R7
About this study
Official title: Plasma Glucose Kinetics Following Ingestion of Two Cereal Products With a Different Content in Slowly Digestible Starch (SDS) in Healthy Males and Females
The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.
Read the detailed description
The present study will compare the effect of consuming cereal products alone on :
- the rates of appearance and disappearance of exogenous and total glucose
- the glycemic and insulinemic responses
- the postprandial GIP concentrations
- Conditions
- Blood Glucose Kinetics
- Being tested
- Nutrition intervention with cereal products
- Keywords
- Starch, cereal products, glucose kinetics, blood glucose, blood insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition intervention with cereal productsOther
acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content
| Study group | Role | What they receive |
|---|---|---|
| High-SDS biscuit | Experimental | Biscuit with high Slowly Digestible Starch content Receives: Other: Nutrition intervention with cereal products |
| Low-SDS cereal product | Active comparator | Cereal product with low Slowly Digestible Starch content Receives: Other: Nutrition intervention with cereal products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appearance of exogenous glucose (RaE)
Postprandial kinetic of RaE
Measured: T0 to 300 minutes
Secondary outcomes (9)
iAUC RaE
iAUC of RaE over selected intervals over the 300-minute postprandial period
Measured: T0 to 300 minutes
kinetics of Rate of disappearance of exogenous glucose (RdE), Rate of appearance of total glucose (RaT), Rate of disappearance of total glucose (RdT) and Endogenous glucose production (EGP)
Postprandial kinetics of RdE, RaT, RdT and EGP
Measured: T0 to 300 minutes
iAUC of RdE, RaT, RdT and EGP
iAUC of RdE, RaT and RdT and dAUC of EGP over selected intervals over the 300-minute postprandial period
Measured: T0 to 300 minutes
kinetics of glycemia and insulinemia
Pre- and postprandial kinetics of glycemia and insulinemia
Measured: T-120 to 300 minutes
iAUC of glycemia and insulinemia
iAUC of glycemia and insulinemia over selected intervals over the 300-minute postprandial period
Measured: T0 to 300 minutes
Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration
Postprandial kinetic of GIP
Measured: T0 to 300 minutes
iAUC of GIP
iAUC of GIP over selected intervals over the 300-minute postprandial period
Measured: T0 to 300 minutes
Kinetics of plasma FFA concentration
Postprandial kinetic of FFA
Measured: T0 to 300 minutes
dAUC of FFA
dAUC of FFA over selected intervals over the 300-minute postprandial period
Measured: T0 to 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose KineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Cliniques de Montreal, Centre de Recherche en Nutrition Humaine Rhone-Alpe, BioFortis, MedQualis
- Responsible party
- Sponsor
- Investigators
- Remi Rabasa-Llhoret, MD, PhD, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323542
- Sponsor's protocol ID
- KBE032
- Status last verified
- Sep 2017
- First submitted
- 18 Dec 2014
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucose Kinetics Following Ingestion of Two Cereal Products With a Different Content in Slowly Digestible Starch (SDS) in Healthy Males and Females
- ClinicalTrials.gov ID
- NCT02323542
- Acronym / sponsor ID
- KBE032
- Conditions
- Blood Glucose Kinetics
- Keywords
- Starch, cereal products, glucose kinetics, blood glucose, blood insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Cliniques de Montreal, Centre de Recherche en Nutrition Humaine Rhone-Alpe, BioFortis, MedQualis
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.
Detailed description
The present study will compare the effect of consuming cereal products alone on :
- the rates of appearance and disappearance of exogenous and total glucose
- the glycemic and insulinemic responses
- the postprandial GIP concentrations
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-SDS biscuit | Experimental | Other: Nutrition intervention with cereal productsBiscuit with high Slowly Digestible Starch content |
| Low-SDS cereal product | Active comparator | Other: Nutrition intervention with cereal productsCereal product with low Slowly Digestible Starch content |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy volunteer, male or female (half male, half female);
- Aged between 18 and 40 years old (bounds included);
- Non-smoker;
- BMI ranging between 18.5 and 25 kg/m2 (bounds included)
- Waist circumference ≤ 94 cm for men and ≤ 80 cm for women;
Key exclusion criteria (11 listed)
- Subject with a severe or acute disease which should influence the results of the study and to be life-threatening for the volunteer according to the Principal Investigator;
- Subject with medical history of symptomatic vascular diseases (infarct, angina pectoris, syndrome of threat, surgery or endovascular surgery, stroke, symptomatic peripheral arteritis) which according to the investigator should interfere with the results from the study or should constitute a particular risk for the subject;
- Subject with type 1 or type 2 diabetes;
- Subject with any food allergy;
- Subject with eating disorders (e.g. anorexia nervosa \& bulimia) according to the Principal Investigator;
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 |
|---|---|---|
| Nutrition intervention with cereal productsacute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content | Other | High-SDS biscuit, Low-SDS cereal product |
Primary outcome
Rate of appearance of exogenous glucose (RaE)
Time frame: T0 to 300 minutes
Postprandial kinetic of RaE
9 secondary outcomes
iAUC RaE
Time frame: T0 to 300 minutes
kinetics of Rate of disappearance of exogenous glucose (RdE), Rate of appearance of total glucose (RaT), Rate of disappearance of total glucose (RdT) and Endogenous glucose production (EGP)
Time frame: T0 to 300 minutes
iAUC of RdE, RaT, RdT and EGP
Time frame: T0 to 300 minutes
kinetics of glycemia and insulinemia
Time frame: T-120 to 300 minutes
iAUC of glycemia and insulinemia
Time frame: T0 to 300 minutes
Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration
Time frame: T0 to 300 minutes
iAUC of GIP
Time frame: T0 to 300 minutes
Kinetics of plasma FFA concentration
Time frame: T0 to 300 minutes
dAUC of FFA
Time frame: T0 to 300 minutes
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 14 Sep 2017.
Related trials for Blood Glucose Kinetics
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A1-Free vs. Conventional Milk Metabolic Response Study
Postprandial Glucose Response, Insulin Response
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.
Remi Rabasa-Llhoret, MD, PhD principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition intervention with cereal products in people with Blood Glucose Kinetics, run by Mondelēz International, Inc. 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 13 inclusion and 11 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 14 Sep 2017. 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?
Rate of appearance of exogenous glucose (RaE) (time frame: T0 to 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2017.