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

This study has been completed.
Sponsor:
Collaborator:
The Danish Agriculture & Food Council
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01773304
First received: January 15, 2013
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Obesity
Bone Metabolism
Other: Dietary meal intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • serum C-terminal carboxy-terminal collagen crosslinks (CTX) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • serum osteocalcin (sOC) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • serum tartrate-resistant acid phosphatase (s-TRAP) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • urine deoxypyridinoline crosslink (uDPD) [ Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits ] [ Designated as safety issue: No ]
  • plasma metabolites for metabolomics analyses [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum insulin-growth factor-1 (IGF-1) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • serum insulin-growth factor binding-protein-3 (IGFBP-3) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • serum insulin [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • serum glucose [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • serum glukagon-like peptide-1 (GLP-1) [ Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]
  • urinary PABA [ Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits ] [ Designated as safety issue: No ]
  • urinary creatinin [ Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits ] [ Designated as safety issue: No ]
  • urinary biobank [ Time Frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits ] [ Designated as safety issue: No ]
  • plasma biobank [ Time Frame: at 0, 30, 60, 90, 120, 180 and 240 min at both visits ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • weight [ Time Frame: at baseline at both visits ] [ Designated as safety issue: No ]
  • height [ Time Frame: at baseline at the first visit ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meal rich in dairy protein Other: Dietary meal intervention
Test meals with different protein types (dairy versus meat)
Experimental: Meal rich in meat protein Other: Dietary meal intervention
Test meals with different protein types (dairy versus meat)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773304

Locations
Denmark
Department of Human Nutrition, University of Copenhagen
Copenhagen, Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Agriculture & Food Council
  More Information

No publications provided

Responsible Party: AAstrup, Dr Med Sci, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01773304     History of Changes
Other Study ID Numbers: M210
Study First Received: January 15, 2013
Last Updated: March 22, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethichs

Keywords provided by University of Copenhagen:
Obesity
Adults
Bone metabolism
Metabolic profile
Dairy protein
Meat protein

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014