Reduction of Sweetened Beverages and Intrahepatic Fat

NCT ID: NCT01394380

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-04-30

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

Conditions

Obesity; Dyslipidemia; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

artificially sweetened beverages

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

Group Type: EXPERIMENTAL

artificially sweetened sodas

Intervention Type: OTHER

subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee

regular sodas

subjects will continue their usual consumption of sweetened sodas

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

artificially sweetened sodas

subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University of Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Luc Tappy, MD

professor of physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luc Tappy, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physiology, University of Lausanne

Locations

Clinical Research Center, CHUV

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

171/11

Identifier Type: -

Identifier Source: org_study_id