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

Not Applicable

Completed

• Conditions: Bone Metabolism; Obesity
• Interventions: Other: Dietary meal intervention

• Registration Number: NCT01773304
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-23
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meal rich in meat protein	Dietary meal intervention	-
Meal rich in dairy protein	Dietary meal intervention	-

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Department of Human Nutrition, University of Copenhagen; 🇩🇰 Copenhagen, Frederiksberg C, Denmark