Effect of Carbonated Soft Drinks on the Body Weight

NCT ID: NCT00777647

Last Updated: 2017-03-29

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-12-31

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 long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).

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 Metabolic; Complications Dietary Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

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

One litre a day for six months.

Aspartame-sweetened soft drink

1.5kJ/100mL

Group Type EXPERIMENTAL

Aspartame-sweetened soft drink

Intervention Type OTHER

One litre a day for six months.

Semi-skimmed milk

202kJ/100mL

Group Type ACTIVE_COMPARATOR

Semi-skimmed milk

Intervention Type OTHER

One litre a day for six months

Water

0kJ/100mL

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

One litre a day for six months.

Interventions

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Sugar-sweetened soft drink

One litre a day for six months.

Intervention Type OTHER

Aspartame-sweetened soft drink

One litre a day for six months.

Intervention Type OTHER

Semi-skimmed milk

One litre a day for six months

Intervention Type OTHER

Water

One litre a day for six months.

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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Maria Maersk Nielsen

MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Bajahzer MF, Bruun JM, Rosqvist F, Marklund M, Richelsen B, Riserus U. Effects of sugar-sweetened soda on plasma saturated and monounsaturated fatty acids in individuals with obesity: A randomized study. Front Nutr. 2022 Aug 31;9:936828. doi: 10.3389/fnut.2022.936828. eCollection 2022.

Reference Type DERIVED
PMID: 36118751 (View on PubMed)

Bruun JM, Maersk M, Belza A, Astrup A, Richelsen B. Consumption of sucrose-sweetened soft drinks increases plasma levels of uric acid in overweight and obese subjects: a 6-month randomised controlled trial. Eur J Clin Nutr. 2015 Aug;69(8):949-53. doi: 10.1038/ejcn.2015.95. Epub 2015 Jun 17.

Reference Type DERIVED
PMID: 26081486 (View on PubMed)

Maersk M, Belza A, Stodkilde-Jorgensen H, Ringgaard S, Chabanova E, Thomsen H, Pedersen SB, Astrup A, Richelsen B. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study. Am J Clin Nutr. 2012 Feb;95(2):283-9. doi: 10.3945/ajcn.111.022533. Epub 2011 Dec 28.

Reference Type DERIVED
PMID: 22205311 (View on PubMed)

Other Identifiers

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20070134B

Identifier Type: -

Identifier Source: org_study_id

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