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Effect of Carbonated Soft Drinks on Appetite-Regulation

NCT ID: NCT00776971

Last Updated: 2008-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

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.

Detailed Description

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Conditions

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Obesity Diet

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Sugar-sweetened soft drink

54g sugar/L, 180kJ/100mL

Group Type EXPERIMENTAL

Sugar-sweetened soft drink

Intervention Type OTHER

500mL as a preload drink

Aspartame-sweetened soft drink

1.5kJ/100mL

Group Type EXPERIMENTAL

Aspartame-sweetened soft drink

Intervention Type OTHER

500mL as a preload drink

Semi-skimmed milk

202kJ/100mL

Group Type ACTIVE_COMPARATOR

Semi-skimmed milk

Intervention Type OTHER

500mL as a preload drink

Water

0kJ/100mL

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

500mL as a preload drink

Interventions

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Sugar-sweetened soft drink

500mL as a preload drink

Intervention Type OTHER

Aspartame-sweetened soft drink

500mL as a preload drink

Intervention Type OTHER

Semi-skimmed milk

500mL as a preload drink

Intervention Type OTHER

Water

500mL as a preload drink

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital

Principal Investigators

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Bjørn Richelsen, Professor

Role: STUDY_CHAIR

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Locations

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Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22252107 (View on PubMed)

Other Identifiers

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20070134A

Identifier Type: -

Identifier Source: org_study_id