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| ID | Type | Description | Link |
|---|---|---|---|
| 120901-10 | Other Identifier | ANSM |
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The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drink with sweeteners | Experimental |
| |
| Drink without sweeteners | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drink with sweeteners | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Matsuda Insulin sensitivity Index | Before and after each of the two 12-week intervention period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice Bonnet, MD, PhD | Centre Hospitalo-Universitaire de Rennes | Principal Investigator |
| Fabrice Lainé, MD, PhD | Centre Hospitalo-Universitaire de Rennes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes | Rennes | 35033 Rennes Cedex 9 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29982723 | Derived | 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. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013549 | Sweetening Agents |
| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
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| Drink without sweeteners | Dietary Supplement | 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. |
|
| 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 |
| D001519 | Behavior |
| D020164 |
| Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |