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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Bone Metabolism

Intervention / Treatment
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* Other: Dietary meal intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal rich in dairy protein<br> | Other: Dietary meal intervention<br>* Test meals with different protein types (dairy versus meat)<br>|
| Experimental: Meal rich in meat protein<br> | Other: Dietary meal intervention<br>* Test meals with different protein types (dairy versus meat)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum C-terminal carboxy-terminal collagen crosslinks (CTX) |  | at 0, 30, 60, 120, 180 and 240 min at both visits | 
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 insulin |  | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Adults, Bone metabolism, Metabolic profile, Dairy protein, Meat protein