NCT00777647|Completed
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Sponsor study identifier
interventional
60
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 21, 2008
Actual (reported)October 22, 2008
Actual (reported)December 2010
Actual (reported)December 2010
Actual (reported)Body Weight (kg)
Six months
MR spectroscopy
to assess liver fat and skeletal muscle fat
Six months
Magnetic resonance imaging
to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)
Six months
Dual-energy X-ray absorptiometry (DEXA) scan
to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)
Six months
Blood pressure
Six months
Circulating metabolic parameters: including serum urate
Six months
fasting plasma glucose
Six months
fasting serum insulin
Six months
Oral Glucose Tolerance Test (OGTT)
Six months
54g sugar/L, 180kJ/100mL
1.5kJ/100mL
202kJ/100mL
One litre a day for six months.
One litre a day for six months.
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, 8000, Denmark
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.
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.
Bjørn Richelsen, Professor
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
60 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
0kJ/100mL
One litre a day for six months
One litre a day for six months.
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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.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
March 29, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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