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Effect of Carbonated Soft Drinks on Appetite-Regulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776971
First Posted: October 22, 2008
Last Update Posted: October 22, 2008
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.
Collaborator:
LG Life Sciences
Information provided by:
Aarhus University Hospital
October 21, 2008
October 22, 2008
October 22, 2008
November 2007
September 2008   (Final data collection date for primary outcome measure)
Visual Analogue Scale [ Time Frame: Four hours ]
Same as current
No Changes Posted
Appetite-regulating hormones, Glucose, Insulin; Energy intake [ Time Frame: Four hours ]
Same as current
Not Provided
Not Provided
 
Effect of Carbonated Soft Drinks on Appetite-Regulation
Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Obesity
  • Diet
  • Other: Sugar-sweetened soft drink
    500mL as a preload drink
  • Other: Aspartame-sweetened soft drink
    500mL as a preload drink
  • Other: Semi-skimmed milk
    500mL as a preload drink
  • Other: Water
    500mL as a preload drink
  • Experimental: Sugar-sweetened soft drink
    54g sugar/L, 180kJ/100mL
    Intervention: Other: Sugar-sweetened soft drink
  • Experimental: Aspartame-sweetened soft drink
    1.5kJ/100mL
    Intervention: Other: Aspartame-sweetened soft drink
  • Active Comparator: Semi-skimmed milk
    202kJ/100mL
    Intervention: Other: Semi-skimmed milk
  • Placebo Comparator: Water
    0kJ/100mL
    Intervention: Other: Water
Maersk M, Belza A, Holst JJ, Fenger-Grøn M, Pedersen SB, Astrup A, Richelsen B. Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):523-9. doi: 10.1038/ejcn.2011.223. Epub 2012 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00776971
20070134A
No
Not Provided
Not Provided
Bjørn Richelsen/ Professor, Aarhus University Hospital
Aarhus University Hospital
LG Life Sciences
Study Chair: Bjørn Richelsen, Professor Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus University Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP