Effect of Carbonated Soft Drinks on Appetite-Regulation

This study has been completed.
Sponsor:
Collaborator:
LG Life Sciences
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00776971
First received: October 21, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: Four hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776971

Locations
Denmark
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
LG Life Sciences
Investigators
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 August 19, 2014