Effect of Carbonated Soft Drinks on Appetite-Regulation

Study Overview
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Brief Summary
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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.

Official Title
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Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.

Conditions
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Obesity, Diet

Intervention / Treatment
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* Other: Sugar-sweetened soft drink
* Other: Aspartame-sweetened soft drink
* Other: Semi-skimmed milk
* Other: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugar-sweetened soft drink<br>54g sugar/L, 180kJ/100mL | Other: Sugar-sweetened soft drink<br>* 500mL as a preload drink<br>|
| Experimental: Aspartame-sweetened soft drink<br>1.5kJ/100mL | Other: Aspartame-sweetened soft drink<br>* 500mL as a preload drink<br>|
| Active Comparator: Semi-skimmed milk<br>202kJ/100mL | Other: Semi-skimmed milk<br>* 500mL as a preload drink<br>|
| Placebo Comparator: Water<br>0kJ/100mL | Other: Water<br>* 500mL as a preload drink<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | Four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite-regulating hormones, Glucose, Insulin; Energy intake |  | Four hours |