Effect of Carbonated Soft Drinks on Appetite-Regulation
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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 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 | Intervention |
|---|---|
|
Obesity Diet |
Other: Sugar-sweetened soft drink Other: Aspartame-sweetened soft drink Other: Semi-skimmed milk Other: Water |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake. |
- Visual Analogue Scale [ Time Frame: Four hours ] [ Designated as safety issue: No ]
- Appetite-regulating hormones, Glucose, Insulin; Energy intake [ Time Frame: Four hours ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (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
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
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: | NCT00776971 History of Changes |
| Other Study ID Numbers: | 20070134A |
| Study First Received: | October 21, 2008 |
| Last Updated: | October 21, 2008 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013