Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

This study has been completed.
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: June 3, 2014
Last verified: June 2014

July 12, 2011
June 3, 2014
October 2011
April 2014   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01394380 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
Not Provided
Not Provided
 
Reduction of Sweetened Beverages and Intrahepatic Fat
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Dyslipidemia
  • Metabolic Syndrome
Other: artificially sweetened sodas
subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
  • Experimental: artificially sweetened beverages
    subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee
    Intervention: Other: artificially sweetened sodas
  • No Intervention: regular sodas
    subjects will continue their usual consumption of sweetened sodas
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01394380
171/11
No
Luc Tappy, MD, University of Lausanne
University of Lausanne
  • Centre Hospitalier Universitaire Vaudois
  • University Hospital Inselspital, Berne
Principal Investigator: Luc Tappy, MD Department of Physiology, University of Lausanne
University of Lausanne
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP