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

Overview

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.

Full Title of Study: “Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

Interventions

  • Other: Dietary meal intervention
    • Test meals with different protein types (dairy versus meat)

Arms, Groups and Cohorts

  • Experimental: Meal rich in dairy protein
  • Experimental: Meal rich in meat protein

Clinical Trial Outcome Measures

Primary Measures

  • serum C-terminal carboxy-terminal collagen crosslinks (CTX)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • 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
  • serum osteocalcin (sOC)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • serum tartrate-resistant acid phosphatase (s-TRAP)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • urine deoxypyridinoline crosslink (uDPD)
    • Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
  • plasma metabolites for metabolomics analyses
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • 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 Measures

  • serum insulin-growth factor-1 (IGF-1)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • serum insulin-growth factor binding-protein-3 (IGFBP-3)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • serum insulin
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • serum glucose
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • serum glukagon-like peptide-1 (GLP-1)
    • Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
  • urinary PABA
    • Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
  • urinary creatinin
    • Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
  • urinary biobank
    • Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
  • plasma biobank
    • Time Frame: at 0, 30, 60, 90, 120, 180 and 240 min at both visits

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Copenhagen
  • Collaborator
    • Danish Agriculture and Food Council
  • Provider of Information About this Clinical Study
    • Principal Investigator: AAstrup, Dr Med Sci – University of Copenhagen

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