Effect of Carbonated Soft Drinks on the Body Weight

Aarhus University Hospital

Status: Completed

Conditions: Metabolic; Complications; Dietary Habits; Obesity

Treatments: Other: Aspartame-sweetened soft drink; Other: Sugar-sweetened soft drink; Other: Water; Other: Semi-skimmed milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00777647

20070134B

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups, including a placebo group

Sugar-sweetened soft drink

Experimental group

Description:

54g sugar/L, 180kJ/100mL

Treatment:

Other: Sugar-sweetened soft drink

Aspartame-sweetened soft drink

Experimental group

Description:

1.5kJ/100mL

Treatment:

Other: Aspartame-sweetened soft drink

Semi-skimmed milk

Active Comparator group

Description:

202kJ/100mL

Treatment:

Other: Semi-skimmed milk

Water

Placebo Comparator group

Description:

0kJ/100mL

Treatment:

Other: Water