Reduction of Sweetened Beverages and Intrahepatic Fat

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome; Dyslipidemia
• Interventions: Other: artificially sweetened sodas

• Registration Number: NCT01394380
• Lead Sponsor: University of Lausanne

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
changes in intrahepatic fat concentration	at the end of run-in and after 12 weeks intervention/control	intrahepatic fat content measured by 1H-MRS

Secondary Outcome Measures

Name	Time	Method
changes in food intake from baseline	at the end of the run-in period and after 6, and 12 weeks of intervention/control	Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record
changes in visceral fat volume	at the end of run-in and after 12 weeks of intervention/control	Visceral fat volume measured by MRI
changes in day-long metabolic profile	at the end of run-in and after 12 weeks of intervention/control	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

Trial Locations

Locations (1)

Clinical Research Center, CHUV; 🇨🇭 Lausanne, VD, Switzerland