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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02031497 |
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Date of registration:
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08/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
SEDULC |
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Scientific title:
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Date of first enrolment:
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October 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02031497 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Fabrice Bonnet, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalo-Universitaire de Rennes |
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Name:
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Fabrice Lainé, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalo-Universitaire de Rennes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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, ... )
- 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glucose Homeostasis
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Intervention(s)
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Dietary Supplement: Drink with sweeteners
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Dietary Supplement: Drink without sweeteners
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Primary Outcome(s)
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Matsuda Insulin sensitivity Index
[Time Frame: Before and after each of the two 12-week intervention period]
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Secondary Outcome(s)
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Physical activity
[Time Frame: Before and after each of the two 12-week intervention period]
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Disposition index defined as Insulin sensitivity x insulinogenic Index
[Time Frame: Before and after each of the two 12-week intervention period]
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Dietary intake
[Time Frame: Before and after each of the two 12-week intervention period]
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Insulinogenic Index defined as ? insulin 0-30 / ? glucose 0-30
[Time Frame: Before and after each of the two 12-week intervention period]
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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]
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Secondary ID(s)
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2012EL0905SEDULC
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120901-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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