HealthyIGNUTNCT01343797
Glycemic and Insulinemic Index Determination of Two Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix
A study testing Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup in people with Healthy, run by CRITT Bio-Industries at 1 site in France.
Trial summary
The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to May 2011
- 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
- Aged between 18 to 50 years (limits included
- With a BMI between 19 and 25 kg/m² (limits included)
- Non-smoker
- Non-menopausal female with reliable contraception for two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
- Capable and willing to conform to the protocol and accepting to give his written informed consent
- Registered to Social Security System
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- Accepting to be registered on the Volunteers in biomedical research file
- After biological analysis, the subjects will be included on the following criteria :
- Fasting blood sugar level < 1,1 g/L
- Blood sugar level 120 minutes after 75g glucose intake < 1.4 g/L
- Complete blood count without significant clinically abnormality according to the investigator
- ASAT < 1,55 µkat/L
- ALAT < 1,7 µkat/L
- GGT < 2,55 µkat/L
- 45 < Creatinine < 104 µmol/L
- 1.7 < Urea < 8.3 mmol/L
Who cannot join
- Known food allergy, in particular to one of the tested products' components or to related products
- Personal history of hypercholesterolemia, high blood pressure, diabetes or glucose intolerance
- Renal insufficiency
- Liver disorders ongoing
- Gastrointestinal disorders, clinically significant according the investigator
- Use of medications which could affect lipidic or carbohydrate metabolism
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- Disease or medication with impact on nutrients digestion and absorption
- Pregnant or breastfeeding women
- General anaesthetic in the month before the study
- Presenting a psychological or linguistic incapability to sign the informed consent
- Refusing to sign the informed consent
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
- Impossible to contact in case of emergency
- Major or medical or surgical event with hospitalization in the last 3 months
- Taking part in an-other clinical trial or being in the exclusion period of a previous clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycemic and Insulinemic Index Determination of 2 Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix
The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.
Read the detailed description
12 male and female healthy adults are included in the study. During 5 separated visits subjects consume either 50 g of glucose in water (3 glucose response tests) or portion of syrup supply the equivalent of 50 g of glycaemic carbohydrates (2 syrup response tests).
Experimental sessions last 3 hours with 9 veinous and capillary blood taking. The experimental meals are served at t0 and are consumed between 12 and 15 minutes maximum. At time -5, 0, 15, 30, 45, 60, 90, 120 and 180 minutes, glucose is measured out on capillary blood and insulin is measured out on venous blood.
The glycemic index and Insulinemic index determination of the 2 syrups start by the calculation for each glycemia and insulinemia responses of the AUC over 120 min. The AUC(0-120min) is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration. then GI and II values expressed in percentage are calculated by dividing the AUC(0-120min) for test syrup products by the AUC(0-120min) for the glucose reference and multiplying by 100.
- Conditions
- Healthy
- Being tested
- Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup
- Keywords
- Glycemic index, Insulinemic index, Fructo-oligosaccharide syrup, Fructose syrup, Aged between eighteen and fifty years old, BMI between nineteen and twenty five kg/m², Non diabetic or pre-diabetic, Without liver, renal or gastro-intestinal disorder, Non-smoker
- Medical subject headings
- Glucose Intolerance, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrupOther
One test with 65,5g of fruit (apple) extract sugar syrup with high fructose content in 250mL of water One test with 108,2g of peach purified sugar syrup with high fructo-oligosaccharid content in 250mL of water Three tests with the reference : 50g of anhydrous glucose in 250mL of water
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the glycemia Curve over 120 min (AUC 0-120min)
Syrup glycemic response compare to glucose glycemic response. Measure with glucometer at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.
Measured: 120 minutes after intake by test
Secondary outcomes (1)
Area Under the insulinemia Curve over 120 min (AUC 0-120min)
Syrup insulinemia response compare to glucose insulinemia response. Measure at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.
Measured: 120 minutes after intake by test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRITT Bio-Industries
- Sponsor type
- University, hospital or other
- Collaborators
- BioFortis, NUTRITIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343797
- Sponsor's protocol ID
- IGNUT PEC10513
- Acronym
- IGNUT
- Status last verified
- Apr 2011
- First submitted
- 20 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Insulinemic Index Determination of 2 Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix
- ClinicalTrials.gov ID
- NCT01343797
- Acronym / sponsor ID
- IGNUT / IGNUT PEC10513
- Conditions
- Healthy
- Keywords
- Glycemic index, Insulinemic index, Fructo-oligosaccharide syrup, Fructose syrup, Aged between eighteen and fifty years old, BMI between nineteen and twenty five kg/m², Non diabetic or pre-diabetic, Without liver, renal or gastro-intestinal disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CRITT Bio-IndustriesUniversity, hospital or other
- Collaborators
- BioFortis, NUTRITIS
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (estimated)
- First posted
- 28 Apr 2011 (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 aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.
Detailed description
12 male and female healthy adults are included in the study. During 5 separated visits subjects consume either 50 g of glucose in water (3 glucose response tests) or portion of syrup supply the equivalent of 50 g of glycaemic carbohydrates (2 syrup response tests).
Experimental sessions last 3 hours with 9 veinous and capillary blood taking. The experimental meals are served at t0 and are consumed between 12 and 15 minutes maximum. At time -5, 0, 15, 30, 45, 60, 90, 120 and 180 minutes, glucose is measured out on capillary blood and insulin is measured out on venous blood.
The glycemic index and Insulinemic index determination of the 2 syrups start by the calculation for each glycemia and insulinemia responses of the AUC over 120 min. The AUC(0-120min) is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration. then GI and II values expressed in percentage are calculated by dividing the AUC(0-120min) for test syrup products by the AUC(0-120min) for the glucose reference and multiplying by 100.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Aged between 18 to 50 years (limits included
- With a BMI between 19 and 25 kg/m² (limits included)
- Non-smoker
- Non-menopausal female with reliable contraception for two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
- Capable and willing to conform to the protocol and accepting to give his written informed consent
Key exclusion criteria (16 listed)
- Known food allergy, in particular to one of the tested products' components or to related products
- Personal history of hypercholesterolemia, high blood pressure, diabetes or glucose intolerance
- Renal insufficiency
- Liver disorders ongoing
- Gastrointestinal disorders, clinically significant according the 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 |
|---|---|---|
| Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrupOne test with 65,5g of fruit (apple) extract sugar syrup with high fructose content in 250mL of water One test with 108,2g of peach purified sugar syrup with high fructo-oligosaccharid content in 250mL of water Three tests with the reference : 50g of anhydrous glucose in 250mL of water | Other | – |
Primary outcome
Area Under the glycemia Curve over 120 min (AUC 0-120min)
Time frame: 120 minutes after intake by test
Syrup glycemic response compare to glucose glycemic response. Measure with glucometer at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.
1 secondary outcome
Area Under the insulinemia Curve over 120 min (AUC 0-120min)
Time frame: 120 minutes after intake by test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup in people with Healthy, run by CRITT Bio-Industries 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 16 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 28 Apr 2011. 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. 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?
Results are not available in the source record.
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?
Area Under the glycemia Curve over 120 min (AUC 0-120min) (time frame: 120 minutes after intake by test). 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 28 Apr 2011.