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.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2007
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedOctober 22, 2008
August 1, 2008
10 months
October 21, 2008
October 21, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale
Four hours
Secondary Outcomes (1)
Appetite-regulating hormones, Glucose, Insulin; Energy intake
Four hours
Study Arms (4)
Sugar-sweetened soft drink
EXPERIMENTAL54g sugar/L, 180kJ/100mL
Aspartame-sweetened soft drink
EXPERIMENTAL1.5kJ/100mL
Semi-skimmed milk
ACTIVE COMPARATOR202kJ/100mL
Water
PLACEBO COMPARATOR0kJ/100mL
Interventions
Eligibility Criteria
You may qualify if:
- Age between 20-50 years;
- BMI between 28-36 kg/m2;
- Less than 10 hours of weekly exercise.
You may not qualify if:
- Diabetes
- Allergic to phenylalanine or milk
- Smoking
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- LG Life Sciencescollaborator
Study Sites (1)
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (1)
Maersk M, Belza A, Holst JJ, Fenger-Gron 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.
PMID: 22252107DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bjørn Richelsen, Professor
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
November 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
October 22, 2008
Record last verified: 2008-08