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Effect of Carbonated Soft Drinks on Appetite-Regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00776971
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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 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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.
Study Start Date : November 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sugar-sweetened soft drink
54g sugar/L, 180kJ/100mL
Other: Sugar-sweetened soft drink
500mL as a preload drink
Experimental: Aspartame-sweetened soft drink
1.5kJ/100mL
Other: Aspartame-sweetened soft drink
500mL as a preload drink
Active Comparator: Semi-skimmed milk
202kJ/100mL
Other: Semi-skimmed milk
500mL as a preload drink
Placebo Comparator: Water
0kJ/100mL
Other: Water
500mL as a preload drink


Outcome Measures

Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: Four hours ]

Secondary Outcome Measures :
  1. Appetite-regulating hormones, Glucose, Insulin; Energy intake [ Time Frame: Four hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776971


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bjørn Richelsen/ Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00776971     History of Changes
Other Study ID Numbers: 20070134A
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: August 2008