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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
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The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| artificially sweetened beverages | Experimental | subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee |
|
| regular sodas | No Intervention | subjects will continue their usual consumption of sweetened sodas |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artificially sweetened sodas | Other | subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in intrahepatic fat concentration | intrahepatic fat content measured by 1H-MRS | at the end of run-in and after 12 weeks intervention/control |
| Measure | Description | Time Frame |
|---|---|---|
| changes in visceral fat volume | Visceral fat volume measured by MRI | at the end of run-in and after 12 weeks of intervention/control |
| changes in day-long metabolic profile | Plasma glucose, insulin, non-esterified fatty acids, and triglycerides will be measured at 2-hourly intervals between 7:00 am and 5:00 pm. Participants will be fed standardized meals and either sweetened or artificially-sweetened beverages according to randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Tappy, MD | Department of Physiology, University of Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, CHUV | Lausanne | Canton of Vaud | CH-1011 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| D024821 | Metabolic Syndrome |
| D005234 | Fatty Liver |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| at the end of run-in and after 12 weeks of intervention/control |
| changes in food intake from baseline | Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record | at the end of the run-in period and after 6, and 12 weeks of intervention/control |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |