Effect of Carbonated Soft Drinks on Appetite-Regulation

Obesity Clinical Trial

Official title:

Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776971
• Other study ID #: 20070134A
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: October 21, 2008
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2008
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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 short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. The study is a crossover, intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served.

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diet
• Obesity

Intervention

Other:
• Sugar-sweetened soft drink
500mL as a preload drink
• Aspartame-sweetened soft drink
500mL as a preload drink
• Semi-skimmed milk
500mL as a preload drink
• Water
500mL as a preload drink

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine/Endocrinology C, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	LG Life Sciences

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale		Four hours	No
Secondary	Appetite-regulating hormones, Glucose, Insulin; Energy intake		Four hours	No