Dietary Habits, Metabolic; Complications, Obesity
Conditions
Brief summary
Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified. The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy). The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.
Interventions
One litre a day for six months.
One litre a day for six months.
OTHERSemi-skimmed milk
One litre a day for six months
OTHERWater
One litre a day for six months.
Sponsors
LG Life Sciences
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 20-50 years; * BMI between 28-36 kg/m2; * Weight stabile 3 months prior to the study inclusion; * Less than 10 hours of weekly exercise
Exclusion criteria
* Diabetes * Allergic to phenylalanine or milk * Smoking * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight (kg) | Six months | — |
| MR spectroscopy | Six months | to assess liver fat and skeletal muscle fat |
| Magnetic resonance imaging | Six months | to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT) |
| Dual-energy X-ray absorptiometry (DEXA) scan | Six months | to assess total fat mass (kg), lean body mass (kg), and bone mass (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Six months | AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index |
| Fasting blood lipids | Six months | Total, LDL, and HDL cholesterol, and TAG (mmol/L) |
| Blood pressure | Six months | Systolic and diastolic blood pressure (mmHg) |
| Fasting plasma PAI-1 | Six months | ng/ml |
| Fasting plasma FFA | Six months | mmol/L |
| Circulating metabolic parameters: including serum urate | Six months | mmol/L |
| fasting plasma glucose | Six months | mmol/L |
| fasting serum insulin | Six months | pmol/L |
Countries
Denmark
Outcome results
None listed