Glucose Homeostasis
Conditions
Keywords
Sweetener, insulin, body mass index, physical activity
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.
Interventions
DIETARY_SUPPLEMENTDrink 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.
DIETARY_SUPPLEMENTDrink 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.
Sponsors
Institute For European Expertise in Physiology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Matsuda Insulin sensitivity Index | Before and after each of the two 12-week intervention period |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed