Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

This study is currently recruiting participants.
Verified February 2013 by University of Lausanne
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01394380
First received: July 12, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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
Obesity
Dyslipidemia
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record


Estimated Enrollment: 68
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394380

Contacts
Contact: Luc Tappy, MD +41 21 692 55 41 luc.tappy@unil.ch
Contact: Vanessa Campos, MSc +41 21 692 55 01 VanessaCaroline.Campos@unil.ch

Locations
Switzerland
Clinical Research Center, CHUV Recruiting
Lausanne, VD, Switzerland, CH-1011
Contact: Gregoire Wuerzner, MD       Gregoire.Wuerzner@chuv.ch   
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Luc Tappy, MD Department of Physiology, University of Lausanne
  More Information

No publications provided

Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT01394380     History of Changes
Other Study ID Numbers: 171/11
Study First Received: July 12, 2011
Last Updated: February 12, 2013
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014