Effect of Carbonated Soft Drinks on the Body Weight

Obesity Clinical Trial

Official title:

Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777647
• Other study ID #: 20070134B
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: March 28, 2017
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2017
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Dietary Habits
• Metabolic; Complications
• Obesity

Intervention

Other:
• Sugar-sweetened soft drink
One litre a day for six months.
• Aspartame-sweetened soft drink
One litre a day for six months.
• Semi-skimmed milk
One litre a day for six months
• Water
One litre a day for six months.

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine/Endocrinology C, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	LG Life Sciences

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight (kg)		Six months
Primary	MR spectroscopy	to assess liver fat and skeletal muscle fat	Six months
Primary	Magnetic resonance imaging	to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)	Six months
Primary	Dual-energy X-ray absorptiometry (DEXA) scan	to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)	Six months
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg)	Six months
Secondary	Circulating metabolic parameters: including serum urate	mmol/L	Six months
Secondary	fasting plasma glucose	mmol/L	Six months
Secondary	fasting serum insulin	pmol/L	Six months
Secondary	Oral Glucose Tolerance Test (OGTT)	AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index	Six months
Secondary	Fasting blood lipids	Total, LDL, and HDL cholesterol, and TAG (mmol/L)	Six months
Secondary	Fasting plasma FFA	mmol/L	Six months
Secondary	Fasting plasma PAI-1	ng/ml	Six months