Effect of Carbonated Soft Drinks on the Body Weight

This study has been completed.
Sponsor:
Collaborator:
LG Life Sciences
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00777647
First received: October 21, 2008
Last updated: June 21, 2011
Last verified: July 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 29, 2014