NCT01394380

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

2.5 years

First QC Date

July 12, 2011

Last Update Submit

June 3, 2014

Conditions

ObesityDyslipidemiaMetabolic Syndrome

Keywords

sugarsweetened beverageshepatic steatosisvisceral obesitymetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • changes in intrahepatic fat concentration

    intrahepatic fat content measured by 1H-MRS

    at the end of run-in and after 12 weeks intervention/control

Secondary Outcomes (3)

  • changes in visceral fat volume

    at the end of run-in and after 12 weeks of intervention/control

  • changes in day-long metabolic profile

    at the end of run-in and after 12 weeks of intervention/control

  • changes in food intake from baseline

    at the end of the run-in period and after 6, and 12 weeks of intervention/control

Study Arms (2)

artificially sweetened beverages

EXPERIMENTAL

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

Other: artificially sweetened sodas

regular sodas

NO INTERVENTION

subjects will continue their usual consumption of sweetened sodas

Interventions

artificially sweetened sodasOTHER

subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee

artificially sweetened beverages

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, CHUV

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

MeSH Terms

Conditions

ObesityDyslipidemiasMetabolic SyndromeFatty LiverObesity, Abdominal

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersLiver DiseasesDigestive System Diseases

Study Officials

  • Luc Tappy, MD

    Department of Physiology, University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of physiology

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

CH(1)