Clinical trial NCT02031497: Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Homeostasis
Keywords: Sweetener, insulin, body mass index, physical activity
Lead sponsor: Institute For European Expertise in Physiology
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Matsuda Insulin sensitivity Index
timeFrame: Before and after each of the two 12-week intervention period
Secondary outcomes:
measure: Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30
timeFrame: Before and after each of the two 12-week intervention period
measure: Disposition index defined as Insulin sensitivity x insulinogenic Index
timeFrame: Before and after each of the two 12-week intervention period
measure: HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5
timeFrame: Before and after each of the two 12-week intervention period
measure: Dietary intake
timeFrame: Before and after each of the two 12-week intervention period
measure: Physical activity
timeFrame: Before and after each of the two 12-week intervention period
Other outcomes:
Locations:
city: Rennes
country: France
facility: Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes
Study officials:
affiliation: Centre Hospitalo-Universitaire de Rennes
name: Fabrice Bonnet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalo-Universitaire de Rennes
name: Fabrice Lainé, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.