Effect of Carbonated Soft Drinks on the Body Weight - Full Text View

Sponsor:	Aarhus University Hospital
Collaborator:	LG Life Sciences
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00777647

Purpose

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.

Condition	Intervention
Obesity Diet	Other: Sugar-sweetened soft drink Other: Aspartame-sweetened soft drink Other: Semi-skimmed milk Other: Water

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Body Weight; MR spectroscopy; MRI; DEXA scan. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Circulating metabolic parameters; blood pressure. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	May 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sugar-sweetened soft drink 54g sugar/L, 180kJ/100mL	Other: Sugar-sweetened soft drink One litre a day for six months.
Experimental: Aspartame-sweetened soft drink 1.5kJ/100mL	Other: Aspartame-sweetened soft drink One litre a day for six months.
Active Comparator: Semi-skimmed milk 202kJ/100mL	Other: Semi-skimmed milk One litre a day for six months
Placebo Comparator: Water 0kJ/100mL	Other: Water One litre a day for six months.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777647

Locations

Denmark
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

Aarhus University Hospital

LG Life Sciences

Investigators

Study Chair:

Bjørn Richelsen, Professor

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

More Information

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maersk M, Belza A, Stødkilde-Jørgensen H, Ringgaard S, Chabanova E, Thomsen H, Pedersen SB, Astrup A, Richelsen B. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study. Am J Clin Nutr. 2012 Feb;95(2):283-9. Epub 2011 Dec 28.

Responsible Party:	Bjørn Richelsen/ Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00777647 History of Changes
Other Study ID Numbers:	20070134B
Study First Received:	October 21, 2008
Last Updated:	June 21, 2011
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:

Body Weight
Obesity
Signs and Symptoms

Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on May 23, 2012