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Completed

NCT Number: NCT01394380

Reduction of Sweetened Beverages and Intrahepatic Fat

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

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Dyslipidemia Dyslipidemias Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, CHUV

Lausanne, Canton of Vaud, CH-1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

artificially sweetened sodas

Other

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

Primary outcomes

  1. changes in intrahepatic fat concentration

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

    intrahepatic fat content measured by 1H-MRS

Secondary outcomes

  1. changes in visceral fat volume

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

    Visceral fat volume measured by MRI

  2. changes in day-long metabolic profile

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

    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

  3. 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

    Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors

Acronym: REDUCS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2011
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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