Overview

This trial is active, not recruiting.

Condition glucose homeostasis
Treatments drink with sweeteners, drink without sweeteners
Sponsor Institute For European Expertise in Physiology
Start date October 2012
End date April 2014
Trial size 60 participants
Trial identifier NCT02031497, 120901-10, 2012EL0905SEDULC

Summary

The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Experimental)
drink with sweeteners
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 sweeteners
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.
(Active Comparator)
drink with sweeteners
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 sweeteners
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.

Primary Outcomes

Measure
Matsuda Insulin sensitivity Index
time frame: Before and after each of the two 12-week intervention period

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Principal investigator Fabrice Bonnet, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Institute For European Expertise in Physiology.