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Completed

NCT Number: NCT01773304

Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile

The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.

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Key information

Conditions

Obesity Body Weight Bone Metabolism Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males and females between 18 and 50 years
  • BMI 25-40

Exclusion criteria

  • Physical activity more than 10 hours weekly
  • Smoking
  • Diagnosed osteoporosis in at least one parent
  • Dietary supplements and vitamin pills (during the study and 2 months before the start)
  • Vegetarians and vegans
  • Lactose intolerant
  • Women who are pregnant, breastfeeding or post-menstrual
  • Regular intake of medication
  • Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders)
  • Participation in other clinical trials that could affect the test results
  • Donation of blod within 3 months before intervention start
  • Hypersensitivity to paraaminobenzoic acid (PABA)
  • Not able to comply with the procedures established by the Protocol

Treatment and study plan

Dietary meal intervention

Other

Test meals with different protein types (dairy versus meat)

Primary outcomes

  1. serum C-terminal carboxy-terminal collagen crosslinks (CTX)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  2. urine C-terminal carboxy-terminal collagen

    Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits

  3. serum osteocalcin (sOC)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  4. serum tartrate-resistant acid phosphatase (s-TRAP)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  5. urine deoxypyridinoline crosslink (uDPD)

    Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits

  6. plasma metabolites for metabolomics analyses

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  7. urine metabolites for metabolomics analyses

    Time frame: baseline 24-h urine samples, 24-h urine samples after the meal test, urine samples at 2-h and 4-h after the meal test and urine samples from 4-h to 24-h, all at both visits

Secondary outcomes

  1. serum insulin-growth factor-1 (IGF-1)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  2. serum insulin-growth factor binding-protein-3 (IGFBP-3)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  3. serum insulin

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  4. serum glucose

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  5. serum glukagon-like peptide-1 (GLP-1)

    Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits

  6. urinary PABA

    Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits

  7. urinary creatinin

    Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits

  8. urinary biobank

    Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits

  9. plasma biobank

    Time frame: at 0, 30, 60, 90, 120, 180 and 240 min at both visits

Other outcomes

  1. weight

    Time frame: at baseline at both visits

  2. height

    Time frame: at baseline at the first visit

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danish Agriculture and Food Council

Registry information

Official study title

Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults

Acronym: MEDA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Mar 25, 2013

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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