GlycaemiaGLYCOFOS-creamNCT02353403
Glycaemic and Insulinaemic Responses After Consumption of FOS.
A study testing Sugar and FOS in people with Glycaemia, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemia
- What is being tested?
- Sugar and FOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Feb 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.0 and 25.0 kg/m² (included)
- Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit
- Be used to have breakfast
- Non-smoker for at least 3 months
- For the female participant: not being pregnant or breastfeeding and using efficient birth control
- Signed the consent form
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- Able to follow the instructions of the study
- Health insured
- Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).
Who cannot join
- Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not)
- Fasting blood cholesterol over 6.35 mmol/L
- Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma)
- Fasting blood insulin under 20 mU/L
- Fasting HbA1c under 7%
- History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not
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- History of dietary allergies or coeliac disease
- History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease
- Somatic or psychiatric disorders
- Renal insufficiency (kidney failure)
- SGOT or ALAT over 52.5 U/L
- Smoker
- Consuming more than 3 alcoholic beverage a day
- Weight varied 3 kg the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.
The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.
- Conditions
- Glycaemia
- Being tested
- Sugar, FOS
- Keywords
- Fructo-oligosaccharides, Sugar-reduced foods, Postprandial glucose response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarOther
A 210g chocolate dairy dessert made with 35g of dextrose.
FOSOther
A 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS.
| Study group | Role | What they receive |
|---|---|---|
| Sugar | Placebo comparator | Control group consuming a dairy dessert containing 35g of dextrose. Receives: Other: Sugar |
| FOS | Experimental | Group consuming a dairy dessert in which 30% of the dextrose was replaced by FOS. Receives: Other: FOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response
Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.
Measured: 2 hours and 5 minutes
Secondary outcomes (5)
Insulinaemic response
Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin.
Measured: 2 hours and 5 minutes
Blood glucose peak (Cmax)
Peak of blood glucose during kinetics.
Measured: One-time data (the highest one) within the 2hrs 5mins kinetics.
Blood insulin peak (Cmax)
Peak of blood insulin during kinetics.
Measured: One-time data (the highest one) within the 2hrs 5mins kinetics.
Glucose Tmax : time to reach the peak of blood glucose
Measured: One time within the 2hrs 5mins kinetics.
Insulin Tmax : time to reach the peak of blood insulin
Measured: One time within the 2hrs 5mins kinetics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycaemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Syral
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353403
- Sponsor's protocol ID
- 2013-A00786-39
- Acronym
- GLYCOFOS-cream
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.
- ClinicalTrials.gov ID
- NCT02353403
- Acronym / sponsor ID
- GLYCOFOS-cream / 2013-A00786-39
- Conditions
- Glycaemia
- Keywords
- Fructo-oligosaccharides, Sugar-reduced foods, Postprandial glucose response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Syral
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Feb 2015 (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 study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar | Placebo comparator | Other: SugarControl group consuming a dairy dessert containing 35g of dextrose. |
| FOS | Experimental | Other: FOSGroup consuming a dairy dessert in which 30% of the dextrose was replaced by FOS. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Body mass index (BMI) between 18.0 and 25.0 kg/m² (included)
- Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit
- Be used to have breakfast
- Non-smoker for at least 3 months
- For the female participant: not being pregnant or breastfeeding and using efficient birth control
Key exclusion criteria (14 listed)
- Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not)
- Fasting blood cholesterol over 6.35 mmol/L
- Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma)
- Fasting blood insulin under 20 mU/L
- Fasting HbA1c under 7%
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 |
|---|---|---|
| SugarA 210g chocolate dairy dessert made with 35g of dextrose. | Other | Sugar |
| FOSA 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS. | Other | FOS |
Primary outcome
Glycaemic response
Time frame: 2 hours and 5 minutes
Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.
5 secondary outcomes
Insulinaemic response
Time frame: 2 hours and 5 minutes
Blood glucose peak (Cmax)
Time frame: One-time data (the highest one) within the 2hrs 5mins kinetics.
Blood insulin peak (Cmax)
Time frame: One-time data (the highest one) within the 2hrs 5mins kinetics.
Glucose Tmax : time to reach the peak of blood glucose
Time frame: One time within the 2hrs 5mins kinetics.
Insulin Tmax : time to reach the peak of blood insulin
Time frame: One time within the 2hrs 5mins kinetics.
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 2 Feb 2015.
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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.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar and FOS in people with Glycaemia, run by Institut Pasteur de Lille at 1 site in France.
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 9 inclusion and 14 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 2 Feb 2015. 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 France. 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. Some participants in this study may receive a placebo. 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?
Glycaemic response (time frame: 2 hours and 5 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 2 Feb 2015.