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Reduction of Sweetened Beverages and Intrahepatic Fat (REDUCS)

Primary Purpose

Obesity, Dyslipidemia, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
artificially sweetened sodas
Sponsored by
University of Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Center, CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

artificially sweetened beverages

regular sodas

Arm Description

subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee

subjects will continue their usual consumption of sweetened sodas

Outcomes

Primary Outcome Measures

changes in intrahepatic fat concentration
intrahepatic fat content measured by 1H-MRS

Secondary Outcome Measures

changes in visceral fat volume
Visceral fat volume measured by MRI
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
changes in food intake from baseline
Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record

Full Information

First Posted
July 12, 2011
Last Updated
June 3, 2014
Sponsor
University of Lausanne
Collaborators
Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01394380
Brief Title
Reduction of Sweetened Beverages and Intrahepatic Fat
Acronym
REDUCS
Official Title
Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne
Collaborators
Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia, Metabolic Syndrome
Keywords
sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artificially sweetened beverages
Arm Type
Experimental
Arm Description
subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee
Arm Title
regular sodas
Arm Type
No Intervention
Arm Description
subjects will continue their usual consumption of sweetened sodas
Intervention Type
Other
Intervention Name(s)
artificially sweetened sodas
Intervention Description
subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
Primary Outcome Measure Information:
Title
changes in intrahepatic fat concentration
Description
intrahepatic fat content measured by 1H-MRS
Time Frame
at the end of run-in and after 12 weeks intervention/control
Secondary Outcome Measure Information:
Title
changes in visceral fat volume
Description
Visceral fat volume measured by MRI
Time Frame
at the end of run-in and after 12 weeks of intervention/control
Title
changes in day-long metabolic profile
Description
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
Time Frame
at the end of run-in and after 12 weeks of intervention/control
Title
changes in food intake from baseline
Description
Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record
Time Frame
at the end of the run-in period and after 6, and 12 weeks of intervention/control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Tappy, MD
Organizational Affiliation
Department of Physiology, University of Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

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Reduction of Sweetened Beverages and Intrahepatic Fat

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