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

Obesity Clinical Trial

— MEDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773304
• Other study ID #: M210
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: March 22, 2013
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethichs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Metabolism
• Obesity

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, University of Copenhagen	Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	The Danish Agriculture & Food Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight		at baseline at both visits	No
Other	height		at baseline at the first visit	No
Primary	serum C-terminal carboxy-terminal collagen crosslinks (CTX)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Primary	urine C-terminal carboxy-terminal collagen		baseline 24-h urine samples and 24-h urine samples after the meal test at both visits	No
Primary	serum osteocalcin (sOC)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Primary	serum tartrate-resistant acid phosphatase (s-TRAP)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Primary	urine deoxypyridinoline crosslink (uDPD)		baseline 24-h urine samples and 24-h urine samples after the meal test at both visits	No
Primary	plasma metabolites for metabolomics analyses		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Primary	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	No
Secondary	serum insulin-growth factor-1 (IGF-1)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Secondary	serum insulin-growth factor binding-protein-3 (IGFBP-3)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Secondary	serum insulin		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Secondary	serum glucose		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Secondary	serum glukagon-like peptide-1 (GLP-1)		at 0, 30, 60, 120, 180 and 240 min at both visits	No
Secondary	urinary PABA		baseline 24-h urine samples and 24-h urine samples after the meal test at both visits	No
Secondary	urinary creatinin		baseline 24-h urine samples and 24-h urine samples after the meal test at both visits	No
Secondary	urinary biobank		baseline 24-h urine samples and 24-h urine samples after the meal test at both visits	No
Secondary	plasma biobank		at 0, 30, 60, 90, 120, 180 and 240 min at both visits	No