Effect of Carbonated Soft Drinks on the Body Weight

NCT00777647 | Completed

• 1 other identifier: 20070134B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic; Complications; Dietary Habits

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• 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

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

Sugar-sweetened soft drink OTHER

One litre a day for six months.

Sugar-sweetened soft drink

Aspartame-sweetened soft drink OTHER

One litre a day for six months.

Aspartame-sweetened soft drink

Semi-skimmed milk OTHER

One litre a day for six months

Semi-skimmed milk

Water OTHER

One litre a day for six months.

Water

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• LG Life Sciences: collaborator

Study Sites (1)

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 36118751 DERIVED

• 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.

  PMID: 26081486 DERIVED

• 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.

  PMID: 22205311 DERIVED

MeSH Terms

Conditions

Obesity; Feeding Behavior

Interventions

Sugar-Sweetened Beverages; Diet, Fat-Restricted; Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen 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
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

DK (1)