Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity

Not Applicable

Completed

• Conditions: Glucose Homeostasis
• Interventions: Dietary Supplement: Drink with sweeteners; Dietary Supplement: Drink without sweeteners

• Registration Number: NCT02031497
• Lead Sponsor: Institute For European Expertise in Physiology

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drink with sweeteners	Drink without sweeteners	-
Drink without sweeteners	Drink without sweeteners	-
Drink with sweeteners	Drink with sweeteners	-
Drink without sweeteners	Drink with sweeteners	-

Primary Outcome Measures

Name	Time	Method
Matsuda Insulin sensitivity Index	Before and after each of the two 12-week intervention period

Secondary Outcome Measures

Name	Time	Method
Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30	Before and after each of the two 12-week intervention period
Disposition index defined as Insulin sensitivity x insulinogenic Index	Before and after each of the two 12-week intervention period
HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5	Before and after each of the two 12-week intervention period
Dietary intake	Before and after each of the two 12-week intervention period
Physical activity	Before and after each of the two 12-week intervention period

Trial Locations

Locations (1)

Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes; 🇫🇷 Rennes, France