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Effect of Carbonated Soft Drinks on the Body Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777647
First Posted: October 22, 2008
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LG Life Sciences
Information provided by (Responsible Party):
Maria Maersk Nielsen, Aarhus University Hospital
  Purpose

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.


Condition Intervention
Obesity Metabolic; Complications Dietary Habits Other: Sugar-sweetened soft drink Other: Aspartame-sweetened soft drink Other: Semi-skimmed milk Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors

Resource links provided by NLM:


Further study details as provided by Maria Maersk Nielsen, Aarhus University Hospital:

Primary Outcome Measures:
  • Body Weight (kg) [ Time Frame: Six months ]
  • MR spectroscopy [ Time Frame: Six months ]
    to assess liver fat and skeletal muscle fat

  • Magnetic resonance imaging [ Time Frame: Six months ]
    to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)

  • Dual-energy X-ray absorptiometry (DEXA) scan [ Time Frame: Six months ]
    to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Six months ]
    Systolic and diastolic blood pressure (mmHg)

  • Circulating metabolic parameters: including serum urate [ Time Frame: Six months ]
    mmol/L

  • fasting plasma glucose [ Time Frame: Six months ]
    mmol/L

  • fasting serum insulin [ Time Frame: Six months ]
    pmol/L

  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: Six months ]
    AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index

  • Fasting blood lipids [ Time Frame: Six months ]
    Total, LDL, and HDL cholesterol, and TAG (mmol/L)

  • Fasting plasma FFA [ Time Frame: Six months ]
    mmol/L

  • Fasting plasma PAI-1 [ Time Frame: Six months ]
    ng/ml


Enrollment: 60
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugar-sweetened soft drink
54g sugar/L, 180kJ/100mL
Other: Sugar-sweetened soft drink
One litre a day for six months.
Experimental: Aspartame-sweetened soft drink
1.5kJ/100mL
Other: Aspartame-sweetened soft drink
One litre a day for six months.
Active Comparator: Semi-skimmed milk
202kJ/100mL
Other: Semi-skimmed milk
One litre a day for six months
Placebo Comparator: Water
0kJ/100mL
Other: Water
One litre a day for six months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777647


Locations
Denmark
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
LG Life Sciences
Investigators
Study Chair: Bjørn Richelsen, Professor Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Maersk Nielsen, MD, PHD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00777647     History of Changes
Other Study ID Numbers: 20070134B
First Submitted: October 21, 2008
First Posted: October 22, 2008
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms