Clinical trial NCT01773304: Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile
Official title: Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bone Metabolism
Keywords: Obesity
Adults
Bone metabolism
Metabolic profile
Dairy protein
Meat protein
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Agriculture and Food Council
First posted: 2013-01-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: serum C-terminal carboxy-terminal collagen crosslinks (CTX)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: urine C-terminal carboxy-terminal collagen
timeFrame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
measure: serum osteocalcin (sOC)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: serum tartrate-resistant acid phosphatase (s-TRAP)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: urine deoxypyridinoline crosslink (uDPD)
timeFrame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
measure: plasma metabolites for metabolomics analyses
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: urine metabolites for metabolomics analyses
timeFrame: 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 outcomes:
measure: serum insulin-growth factor-1 (IGF-1)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: serum insulin-growth factor binding-protein-3 (IGFBP-3)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: serum insulin
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: serum glucose
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: serum glukagon-like peptide-1 (GLP-1)
timeFrame: at 0, 30, 60, 120, 180 and 240 min at both visits
measure: urinary PABA
timeFrame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
measure: urinary creatinin
timeFrame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
measure: urinary biobank
timeFrame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
measure: plasma biobank
timeFrame: at 0, 30, 60, 90, 120, 180 and 240 min at both visits
Other outcomes:
measure: weight
timeFrame: at baseline at both visits
measure: height
timeFrame: at baseline at the first visit
Locations:
city: Copenhagen
country: Denmark
facility: Department of Human Nutrition, University of Copenhagen
state: Frederiksberg C
Study officials:
References: