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CompletedNCT01394380REDUCSUpdated Jun 4, 2014

Reduction of Sweetened Beverages and Intrahepatic Fat

An interventional study of artificially sweetened sodas in Obesity, Dyslipidemia and Metabolic Syndrome, sponsored by University of Lausanne. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-06-04.

Sponsored by University of Lausanne · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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
02

Conditions studied

  • Obesity
  • Dyslipidemia
  • Metabolic Syndrome

Keywords

  • sugar
  • sweetened beverages
  • hepatic steatosis
  • visceral obesity
  • metabolic syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Lausanne is the lead sponsor of 54 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    artificially sweetened beverages

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

    Other: artificially sweetened sodas

  • No intervention
    regular sodas

    subjects will continue their usual consumption of sweetened sodas

Interventions

  • Otherartificially sweetened sodas

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

06

What researchers measure

Primary outcomes

  1. changes in intrahepatic fat concentration

    intrahepatic fat content measured by 1H-MRS

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

Secondary outcomes

  1. changes in visceral fat volume

    Visceral fat volume measured by MRI

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

  2. 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

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

  3. changes in food intake from baseline

    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

07

Study locations

1 site
  • Clinical Research Center, CHUV
    Lausanne, VD CH-1011, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01394380
Lead sponsor
University of Lausanne
Collaborators
Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern
Responsible party
Luc Tappy, MD (professor of physiology, University of Lausanne) — Principal investigator
First posted
Jul 14, 2011
Start date
Oct 2011
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jun 4, 2014

Study contacts

Luc Tappy, MD
principal investigator · Department of Physiology, University of Lausanne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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