Dyslipidemia, Metabolic Syndrome, Obesity
Conditions
Keywords
sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome
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
Interventions
OTHERartificially sweetened sodas
subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
Sponsors
Centre Hospitalier Universitaire Vaudois
Insel Gruppe AG, University Hospital Bern
University of Lausanne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in intrahepatic fat concentration | at the end of run-in and after 12 weeks intervention/control | intrahepatic fat content measured by 1H-MRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in visceral fat volume | at the end of run-in and after 12 weeks of intervention/control | Visceral fat volume measured by MRI |
| changes in day-long metabolic profile | 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 |
| changes in food intake from baseline | 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 |
Countries
Switzerland
Outcome results
None listed