NCT00776971

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
Last Updated

October 22, 2008

Status Verified

August 1, 2008

Enrollment Period

10 months

First QC Date

October 21, 2008

Last Update Submit

October 21, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Four hours

Secondary Outcomes (1)

  • Appetite-regulating hormones, Glucose, Insulin; Energy intake

    Four hours

Study Arms (4)

Sugar-sweetened soft drink

EXPERIMENTAL

54g sugar/L, 180kJ/100mL

Other: Sugar-sweetened soft drink

Aspartame-sweetened soft drink

EXPERIMENTAL

1.5kJ/100mL

Other: Aspartame-sweetened soft drink

Semi-skimmed milk

ACTIVE COMPARATOR

202kJ/100mL

Other: Semi-skimmed milk

Water

PLACEBO COMPARATOR

0kJ/100mL

Other: Water

Interventions

500mL as a preload drink

Sugar-sweetened soft drink

500mL as a preload drink

Aspartame-sweetened soft drink

500mL as a preload drink

Semi-skimmed milk
WaterOTHER

500mL as a preload drink

Water

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-50 years;
  • BMI between 28-36 kg/m2;
  • Less than 10 hours of weekly exercise.

You may not qualify if:

  • Diabetes
  • Allergic to phenylalanine or milk
  • Smoking
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Maersk M, Belza A, Holst JJ, Fenger-Gron M, Pedersen SB, Astrup A, Richelsen B. Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):523-9. doi: 10.1038/ejcn.2011.223. Epub 2012 Jan 18.

MeSH Terms

Conditions

Obesity

Interventions

Sugar-Sweetened BeveragesDiet, Fat-RestrictedWater

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Bjørn Richelsen, Professor

    Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 22, 2008

Record last verified: 2008-08

Locations