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Completed

NCT Number: NCT00777647

Effect of Carbonated Soft Drinks on the Body Weight

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.

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Key information

Conditions

Obesity Behavior Behavior, Animal Body Weight Dietary Habits Feeding Behavior Metabolic; Complications Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugar-sweetened soft drink

Other

One litre a day for six months.

Aspartame-sweetened soft drink

Other

One litre a day for six months.

Semi-skimmed milk

Other

One litre a day for six months

Water

Other

One litre a day for six months.

Primary outcomes

  1. Body Weight (kg)

    Time frame: Six months

  2. MR spectroscopy

    Time frame: Six months

    to assess liver fat and skeletal muscle fat

  3. Magnetic resonance imaging

    Time frame: Six months

    to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)

  4. 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 outcomes

  1. Blood pressure

    Time frame: Six months

    Systolic and diastolic blood pressure (mmHg)

  2. Circulating metabolic parameters: including serum urate

    Time frame: Six months

    mmol/L

  3. fasting plasma glucose

    Time frame: Six months

    mmol/L

  4. fasting serum insulin

    Time frame: Six months

    pmol/L

  5. Oral Glucose Tolerance Test (OGTT)

    Time frame: Six months

    AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index

  6. Fasting blood lipids

    Time frame: Six months

    Total, LDL, and HDL cholesterol, and TAG (mmol/L)

  7. Fasting plasma FFA

    Time frame: Six months

    mmol/L

  8. Fasting plasma PAI-1

    Time frame: Six months

    ng/ml

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • LG Life Sciences

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2008
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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