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
  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


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394380

Locations
Switzerland
Clinical Research Center, CHUV
Lausanne, VD, Switzerland, CH-1011
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: June 3, 2014
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 August 27, 2014