Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

University of Lausanne (UNIL)

Status: Completed

Conditions: Obesity; Dyslipidemia; Metabolic Syndrome

Treatments: Other: artificially sweetened sodas

Study type: Interventional

Funder types: Other

Identifiers

NCT01394380

171/11

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

artificially sweetened beverages

Experimental group

Description:

subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee

Treatment:

Other: artificially sweetened sodas

regular sodas

No Intervention group

Description:

subjects will continue their usual consumption of sweetened sodas