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Completed

NCT Number: NCT01199835

The Effects of Dairy Products on Energy Balance

The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • men and women,
  • medium overweight (body mass index 28-36 kg/m2),
  • 18-60 years old,
  • low habitual calcium intake (<800 mg/d)

Exclusion criteria

  • milk allergy, infection diseases and diabetes,
  • intake of dietary supplements,
  • smoking,
  • pregnancy and/or breast feeding,
  • any medications known to affect the outcome measurements,
  • weigh reducing diet,
  • gastrointestinal diseases,
  • participation in other intervention studies

Treatment and study plan

High Calcium intake from dairy products

Other

High dietary intake of calcium from dairy products (~1200 mg/d)

Primary outcomes

  1. Fecal fat excretion

    Time frame: 24 weeks

  2. Body weight

    Time frame: 24 weeks

  3. body composition

    Time frame: 24 weeks

Secondary outcomes

  1. Resting energy expenditure

    Time frame: 24 weeks

  2. Blood pressure

    Time frame: 24 weeks

  3. Appetite regulation

    Time frame: 24 weeks

  4. Lipid profile

    Time frame: 24 weeks

  5. Intestinal micro flora

    Time frame: 24 weeks

  6. Metabolomics in urine, feces and blood

    Time frame: 24 week

  7. calcium excretion

    Time frame: 24 weeks

  8. bone markers

    Time frame: 24 weeks

  9. vitamin D status

    Time frame: 24 weeks

  10. calcium status

    Time frame: 24 weeks

  11. lipid metabolism

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Danish Dairy Research Foundation, Denmark
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Acronym: MEPEB

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2010
Registry last updated
Jun 11, 2014

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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