Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Dyslipidemia
• Intervention / Treatment: Other: artificially sweetened sodas

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, CH-1011
      • Clinical Research Center, CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: artificially sweetened beverages; subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee	Other: artificially sweetened sodas; subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
NO_INTERVENTION: regular sodas; subjects will continue their usual consumption of sweetened sodas

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne
• Collaborators: University Hospital Inselspital, Berne; Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Luc Tappy, MD, Department of Physiology, University of Lausanne

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (ESTIMATE): July 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: metabolic syndrome; hepatic steatosis; sugar; sweetened beverages; visceral obesity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: 171/11