Effect of Carbonated Soft Drinks on Appetite-Regulation
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ClinicalTrials.gov Identifier: NCT00776971 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
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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 | Phase |
---|---|---|
Obesity Diet | Other: Sugar-sweetened soft drink Other: Aspartame-sweetened soft drink Other: Semi-skimmed milk Other: Water | Not Applicable |
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 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |
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 |
- Visual Analogue Scale [ Time Frame: Four hours ]
- Appetite-regulating hormones, Glucose, Insulin; Energy intake [ Time Frame: Four hours ]

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Denmark | |
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital | |
Aarhus, Denmark, 8000 |
Study Chair: | Bjørn Richelsen, Professor | Department of Internal Medicine/Endocrinology C, Aarhus University Hospital |
Responsible Party: | Bjørn Richelsen/ Professor, Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT00776971 |
Other Study ID Numbers: |
20070134A |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | October 22, 2008 |
Last Verified: | August 2008 |