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Completed

NCT Number: NCT00776971

Effect of Carbonated Soft Drinks on Appetite-Regulation

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.

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Key information

Conditions

Obesity Body Weight Diet Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugar-sweetened soft drink

Other

500mL as a preload drink

Aspartame-sweetened soft drink

Other

500mL as a preload drink

Semi-skimmed milk

Other

500mL as a preload drink

Water

Other

500mL as a preload drink

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Four hours

Secondary outcomes

  1. Appetite-regulating hormones, Glucose, Insulin; Energy intake

    Time frame: Four hours

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • LG Life Sciences

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 22, 2008
Registry last updated
Oct 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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