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

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

Detailed Description
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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.

Conditions
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Glucose Homeostasis

Intervention / Treatment
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* Dietary Supplement: Drink with sweeteners
* Dietary Supplement: Drink without sweeteners


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drink with sweeteners<br> | Dietary Supplement: Drink with sweeteners<br>* 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.<br>Dietary Supplement: Drink without sweeteners<br>* 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.<br>|
| Active Comparator: Drink without sweeteners<br> | Dietary Supplement: Drink with sweeteners<br>* 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.<br>Dietary Supplement: Drink without sweeteners<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matsuda Insulin sensitivity Index |  | Before and after each of the two 12-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sweetener, insulin, body mass index, physical activity