Reduction of Sweetened Beverages and Intrahepatic Fat

Obesity Clinical Trial

— REDUCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394380
• Other study ID #: 171/11
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: June 3, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

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

Locations

Country	Name	City	State
Switzerland	Clinical Research Center, CHUV	Lausanne	VD

Sponsors (3)

Lead Sponsor	Collaborator
University of Lausanne	Centre Hospitalier Universitaire Vaudois, University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in intrahepatic fat concentration	intrahepatic fat content measured by 1H-MRS	at the end of run-in and after 12 weeks intervention/control	No
Secondary	changes in visceral fat volume	Visceral fat volume measured by MRI	at the end of run-in and after 12 weeks of intervention/control	No
Secondary	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	at the end of run-in and after 12 weeks of intervention/control	No
Secondary	changes in food intake from baseline	Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record	at the end of the run-in period and after 6, and 12 weeks of intervention/control	No