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Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

This study has been completed.
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne Identifier:
First received: July 12, 2011
Last updated: June 3, 2014
Last verified: June 2014

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

Condition Intervention
Metabolic Syndrome
Other: artificially sweetened sodas

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors

Resource links provided by NLM:

Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • changes in intrahepatic fat concentration [ Time Frame: at the end of run-in and after 12 weeks intervention/control ]
    intrahepatic fat content measured by 1H-MRS

Secondary Outcome Measures:
  • changes in visceral fat volume [ Time Frame: 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 [ Time Frame: 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

  • changes in food intake from baseline [ Time Frame: 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

Enrollment: 29
Study Start Date: October 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01394380

Clinical Research Center, CHUV
Lausanne, VD, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Principal Investigator: Luc Tappy, MD Department of Physiology, University of Lausanne
  More Information

Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne Identifier: NCT01394380     History of Changes
Other Study ID Numbers: 171/11
Study First Received: July 12, 2011
Last Updated: June 3, 2014

Keywords provided by University of Lausanne:
sweetened beverages
hepatic steatosis
visceral obesity
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders processed this record on May 23, 2017