Reduction of Sweetened Beverages and Intrahepatic Fat

Study Overview
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Brief Summary
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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 intrahepatic fat concentration visceral fat volume changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations) changes in food intake and daily energy, carbohydrate and sugars intake from baseline

Official Title
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Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors

Conditions
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Obesity, Dyslipidemia, Metabolic Syndrome

Intervention / Treatment
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* Other: artificially sweetened sodas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gender male or female body mass index (BMI) > 27 kg/m2 consumption of > 2 3dl-can regular soda/day low to moderate physical activity (< 60 min walking/day; < 3 exercise session/week Exclusion Criteria: diabetes mellitus liver, kidney or heart disease any current drug treatment contra-indications to MR examination (pacemaker, foreign bodies,etc) pregnancy or planned pregnancy active weight gain or weight loss (weight change > 4 kg in the past 12 months) consumption of drugs or illicit substances consumption of more than 10g alcohol/day vegetarians or subjects on special diets

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: artificially sweetened beverages<br>subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee | Other: artificially sweetened sodas<br>* subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee<br>|
| No Intervention: regular sodas<br>subjects will continue their usual consumption of sweetened sodas | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome