Effect of Carbonated Soft Drinks on the Body Weight

Not Applicable

Completed

• Conditions: Obesity; Metabolic; Complications; Dietary Habits
• Interventions: Other: Semi-skimmed milk; Other: Aspartame-sweetened soft drink; Other: Water; Other: Sugar-sweetened soft drink

• Registration Number: NCT00777647
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semi-skimmed milk	Semi-skimmed milk	202kJ/100mL
Aspartame-sweetened soft drink	Aspartame-sweetened soft drink	1.5kJ/100mL
Water	Water	0kJ/100mL
Sugar-sweetened soft drink	Sugar-sweetened soft drink	54g sugar/L, 180kJ/100mL

Primary Outcome Measures

Name	Time	Method
Body Weight (kg)	Six months
MR spectroscopy	Six months	to assess liver fat and skeletal muscle fat
Dual-energy X-ray absorptiometry (DEXA) scan	Six months	to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)
Magnetic resonance imaging	Six months	to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)

Secondary Outcome Measures

Name	Time	Method
Fasting plasma PAI-1	Six months	ng/ml
fasting serum insulin	Six months	pmol/L
Blood pressure	Six months	Systolic and diastolic blood pressure (mmHg)
Circulating metabolic parameters: including serum urate	Six months	mmol/L
Oral Glucose Tolerance Test (OGTT)	Six months	AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index
Fasting plasma FFA	Six months	mmol/L
fasting plasma glucose	Six months	mmol/L
Fasting blood lipids	Six months	Total, LDL, and HDL cholesterol, and TAG (mmol/L)

Trial Locations

Locations (1)

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark