Healthy VolunteersNCT00717912
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
A study testing Experimental sweetener syrup, Classical sweetener syrup and Classical sugar syrup in people with Healthy Volunteers, run by Routin SA at 1 site in France.
Trial summary
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Experimental sweetener syrup, Classical sweetener syrup and Classical sugar syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-50 years
- male
- healthy volunteers
- BMI above 25 kg/m²
Who cannot join
- no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance
- food allergy
- kidney deficiency
- liver troubles
- gastro-intestinal troubles
- drugs which impair sugar and lipid metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Glycemic Index and the Insulinemic Index of a Sweetener
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup
Read the detailed description
Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index.
Insulinemic index is measure with the same methodology.
- Conditions
- Healthy Volunteers
- Being tested
- Experimental sweetener syrup, Classical sweetener syrup, Classical sugar syrup
- Keywords
- BLOOD GLUCOSE, glycemic index, rates of digestion and absorption of food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental sweetener syrupOther
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Classical sweetener syrupOther
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Classical sugar syrupOther
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
| Arm 2 | Experimental | Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
| Arm 3 | Experimental | Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
| Arm 4 | Experimental | Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
| Arm 5 | Experimental | Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
| Arm 6 | Experimental | Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup Receives: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index
The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.
Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above
Measured: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Secondary outcomes (1)
Insulinemic Index
The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.
Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above
Measured: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Routin SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Cazaubiel, Doctor, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717912
- Sponsor's protocol ID
- SIRODEX 9708
- Status last verified
- Jul 2017
- First submitted
- 16 Jul 2008
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic Index and the Insulinemic Index of a Sweetener
- ClinicalTrials.gov ID
- NCT00717912
- Acronym / sponsor ID
- SIRODEX 9708
- Conditions
- Healthy Volunteers
- Keywords
- BLOOD GLUCOSE, glycemic index, rates of digestion and absorption of food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Routin SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup
Detailed description
Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index.
Insulinemic index is measure with the same methodology.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupClassical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup |
| Arm 2 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupExperimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup |
| Arm 3 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupExperimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup |
| Arm 4 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupExperimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup |
| Arm 5 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupClassical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup |
| Arm 6 | Experimental | Other: Experimental sweetener syrup, Other: Classical sweetener syrup, Other: Classical sugar syrupExperimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-50 years
- male
- healthy volunteers
- BMI above 25 kg/m²
Key exclusion criteria (6 listed)
- no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance
- food allergy
- kidney deficiency
- liver troubles
- gastro-intestinal troubles
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 |
|---|---|---|
| Experimental sweetener syrup3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber | Other | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| Classical sweetener syrup1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber | Other | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| Classical sugar syrup3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber | Other | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Glycemic Index
Time frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate. Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above
1 secondary outcome
Insulinemic Index
Time frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Research Organisation in Human NutritionLink provided by the sponsor.
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Screening Protocol
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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-Marc Cazaubiel, Doctor principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental sweetener syrup, Classical sweetener syrup and Classical sugar syrup in people with Healthy Volunteers, run by Routin SA 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 4 inclusion and 6 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 13 Jul 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 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?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Index (time frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge). 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 13 Jul 2017.