Glucose HomeostasisSEDULCNCT02031497
Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
A study testing Drink with sweeteners and Drink without sweeteners in people with Glucose Homeostasis, run by Institute For European Expertise in Physiology at 1 site in France.
Trial summary
The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Homeostasis
- What is being tested?
- Drink with sweeteners and Drink without sweeteners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Dec 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
- Healthy male or female
- Subject taking at least three main meals (breakfast, lunch, dinner)
- Subject able to understand and sign an informed consent
- Subject drinking and enjoying soft drinks
- Subject appreciating sweeteners taste
- 19 kg/m² < BMI< 30 kg/m²
Who cannot join
- Any severe or acute illness that may influence the results of the study or may be life-threatening
- Pregnant or breastfeeding subject
- Past or present metabolic or digestive diseases, with the exception of a possible appendectomy
- Diabetes or severe acute illness that may alter blood sugar
- Treatment that may interfere with glucose homeostasis
- Past or present kidney disease (renal failure, ... )
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- Local or systemic medication that may change water status, metabolism and feeding behavior
- Antiplatelet treatment
- Alcohol consumption ≥ 3-4 glasses / day ( ≥ 21 drinks / week )
- Sustained physical exercise (more than 4 hours per week)
- Subject adding sweeteners (tablets or powder) in their diet
- Subject drinking more than two cans of drinks with sweeteners / day
- Subject dieting to lose weight
- Subject unable or unwilling to consume 2 liters of fluid / day
Trial locations and contacts
1 site in 1 country.
France1 site
Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes
Rennes, 35033 Rennes Cedex 9
About this study
The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.
Read the detailed description
Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to drink and food with few or no additional calories. Sweeteners are widely used in commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a reasonable level of consumption (less than 20 cans per day). However little data is available on the metabolic effects of a regular consumption of beverages containing sweeteners. The objective of the study is to evaluate the effect of a regular consumption (twice a day for 12 weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.
- Conditions
- Glucose Homeostasis
- Being tested
- Drink with sweeteners, Drink without sweeteners
- Keywords
- Sweetener, insulin, body mass index, physical activity
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink with sweetenersDietary supplement
Subjects will have to consume a 330ml can of a drink with sweeteners twice per day as part of their usual fluid intake for 12 weeks.
Drink without sweetenersDietary supplement
Subjects will have to consume a 330ml can of a drink without sweeteners twice per day as part of their usual fluid intake for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Drink with sweeteners | Experimental | Not described Receives: Dietary Supplement: Drink with sweeteners; Dietary Supplement: Drink without sweeteners |
| Drink without sweeteners | Active comparator | Not described Receives: Dietary Supplement: Drink with sweeteners; Dietary Supplement: Drink without sweeteners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Insulin sensitivity Index
Measured: Before and after each of the two 12-week intervention period
Secondary outcomes (5)
Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30
Measured: Before and after each of the two 12-week intervention period
Disposition index defined as Insulin sensitivity x insulinogenic Index
Measured: Before and after each of the two 12-week intervention period
HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5
Measured: Before and after each of the two 12-week intervention period
Dietary intake
Measured: Before and after each of the two 12-week intervention period
Physical activity
Measured: Before and after each of the two 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionDec 2014
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 Glucose HomeostasisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute For European Expertise in Physiology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabrice Bonnet, MD, PhD, Principal investigator, Centre Hospitalo-Universitaire de RennesFabrice Lainé, MD, PhD, Study director, Centre Hospitalo-Universitaire de Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031497
- Sponsor's protocol ID
- 2012EL0905SEDULC
- Other IDs
- 120901-10
- Acronym
- SEDULC
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Laine F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.
PubMed 29982723
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT02031497
- Acronym / sponsor ID
- SEDULC / 2012EL0905SEDULC
- Conditions
- Glucose Homeostasis
- Keywords
- Sweetener, insulin, body mass index, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute For European Expertise in PhysiologyIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Jan 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 purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.
Detailed description
Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to drink and food with few or no additional calories. Sweeteners are widely used in commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a reasonable level of consumption (less than 20 cans per day). However little data is available on the metabolic effects of a regular consumption of beverages containing sweeteners. The objective of the study is to evaluate the effect of a regular consumption (twice a day for 12 weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drink with sweeteners | Experimental | Dietary Supplement: Drink with sweeteners, Dietary Supplement: Drink without sweeteners |
| Drink without sweeteners | Active comparator | Dietary Supplement: Drink with sweeteners, Dietary Supplement: Drink without sweeteners |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female
- Subject taking at least three main meals (breakfast, lunch, dinner)
- Subject able to understand and sign an informed consent
- Subject drinking and enjoying soft drinks
- Subject appreciating sweeteners taste
Key exclusion criteria (14 listed)
- Any severe or acute illness that may influence the results of the study or may be life-threatening
- Pregnant or breastfeeding subject
- Past or present metabolic or digestive diseases, with the exception of a possible appendectomy
- Diabetes or severe acute illness that may alter blood sugar
- Treatment that may interfere with glucose homeostasis
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 |
|---|---|---|
| Drink with sweetenersSubjects will have to consume a 330ml can of a drink with sweeteners twice per day as part of their usual fluid intake for 12 weeks. | Dietary supplement | Drink with sweeteners, Drink without sweeteners |
| Drink without sweetenersSubjects will have to consume a 330ml can of a drink without sweeteners twice per day as part of their usual fluid intake for 12 weeks. | Dietary supplement | Drink with sweeteners, Drink without sweeteners |
Primary outcome
Matsuda Insulin sensitivity Index
Time frame: Before and after each of the two 12-week intervention period
5 secondary outcomes
Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30
Time frame: Before and after each of the two 12-week intervention period
Disposition index defined as Insulin sensitivity x insulinogenic Index
Time frame: Before and after each of the two 12-week intervention period
HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5
Time frame: Before and after each of the two 12-week intervention period
Dietary intake
Time frame: Before and after each of the two 12-week intervention period
Physical activity
Time frame: Before and after each of the two 12-week intervention period
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 3 Mar 2017.
- Derived from this study: PubMed 29982723Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Laine F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.
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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.
Fabrice Bonnet, MD, PhD principal investigator
Centre Hospitalo-Universitaire de Rennes
Fabrice Lainé, MD, PhD study director
Centre Hospitalo-Universitaire de Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink with sweeteners and Drink without sweeteners in people with Glucose Homeostasis, run by Institute For European Expertise in Physiology 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 6 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 3 Mar 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?
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?
Matsuda Insulin sensitivity Index (time frame: Before and after each of the two 12-week intervention period). 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 NCT02031497, 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 3 Mar 2017.