Clinical trial NCT00777647: Effect of Carbonated Soft Drinks on the Body Weight
Official title: Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic; Complications
Dietary Habits
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2008-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


Eligibility 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

Primary outcomes:
measure: Body Weight (kg)
timeFrame: Six months
measure: MR spectroscopy
timeFrame: Six months
measure: Magnetic resonance imaging
timeFrame: Six months
measure: Dual-energy X-ray absorptiometry (DEXA) scan
timeFrame: Six months
Secondary outcomes:
measure: Blood pressure
timeFrame: Six months
measure: Circulating metabolic parameters: including serum urate
timeFrame: Six months
measure: fasting plasma glucose
timeFrame: Six months
measure: fasting serum insulin
timeFrame: Six months
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: Six months
measure: Fasting blood lipids
timeFrame: Six months
measure: Fasting plasma FFA
timeFrame: Six months
measure: Fasting plasma PAI-1
timeFrame: Six months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Study officials:
affiliation: Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
name: Bjørn Richelsen, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.