ObesityMEDANCT01773304
Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile
A study testing Dietary meal intervention in people with Obesity and Bone Metabolism, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bone Metabolism
- What is being tested?
- Dietary meal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between 18 and 50 years
- BMI 25-40
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Copenhagen, Frederiksberg C, 1958
About this study
Official title: Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults
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.
- Conditions
- Obesity, Bone Metabolism
- Being tested
- Dietary meal intervention
- Keywords
- Obesity, Adults, Bone metabolism, Metabolic profile, Dairy protein, Meat protein
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary meal interventionOther
Test meals with different protein types (dairy versus meat)
| Study group | Role | What they receive |
|---|---|---|
| Meal rich in dairy protein | Experimental | Not described Receives: Other: Dietary meal intervention |
| Meal rich in meat protein | Experimental | Not described Receives: Other: Dietary meal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum C-terminal carboxy-terminal collagen crosslinks (CTX)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
urine C-terminal carboxy-terminal collagen
Measured: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
serum osteocalcin (sOC)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
serum tartrate-resistant acid phosphatase (s-TRAP)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
urine deoxypyridinoline crosslink (uDPD)
Measured: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
plasma metabolites for metabolomics analyses
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
urine metabolites for metabolomics analyses
Measured: 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 (9)
serum insulin-growth factor-1 (IGF-1)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
serum insulin-growth factor binding-protein-3 (IGFBP-3)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
serum insulin
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
serum glucose
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
serum glukagon-like peptide-1 (GLP-1)
Measured: at 0, 30, 60, 120, 180 and 240 min at both visits
urinary PABA
Measured: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
urinary creatinin
Measured: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
urinary biobank
Measured: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
plasma biobank
Measured: at 0, 30, 60, 90, 120, 180 and 240 min at both visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Agriculture and Food Council
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773304
- Sponsor's protocol ID
- M210
- Acronym
- MEDA
- Status last verified
- Mar 2013
- First submitted
- 15 Jan 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults
- ClinicalTrials.gov ID
- NCT01773304
- Acronym / sponsor ID
- MEDA / M210
- Conditions
- Obesity, Bone Metabolism
- Keywords
- Obesity, Adults, Bone metabolism, Metabolic profile, Dairy protein, Meat protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Agriculture and Food Council
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal rich in dairy protein | Experimental | Other: Dietary meal intervention |
| Meal rich in meat protein | Experimental | Other: Dietary meal intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females between 18 and 50 years
- BMI 25-40
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary meal interventionTest meals with different protein types (dairy versus meat) | Other | Meal rich in dairy protein, Meal rich in meat protein |
Primary outcome
serum C-terminal carboxy-terminal collagen crosslinks (CTX)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
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
serum osteocalcin (sOC)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
serum tartrate-resistant acid phosphatase (s-TRAP)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
urine deoxypyridinoline crosslink (uDPD)
Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
plasma metabolites for metabolomics analyses
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
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
9 secondary outcomes
serum insulin-growth factor-1 (IGF-1)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
serum insulin-growth factor binding-protein-3 (IGFBP-3)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
serum insulin
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
serum glucose
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
serum glukagon-like peptide-1 (GLP-1)
Time frame: at 0, 30, 60, 120, 180 and 240 min at both visits
urinary PABA
Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
urinary creatinin
Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
urinary biobank
Time frame: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
plasma biobank
Time frame: at 0, 30, 60, 90, 120, 180 and 240 min at both visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary meal intervention in people with Obesity and Bone Metabolism, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum C-terminal carboxy-terminal collagen crosslinks (CTX) (time frame: at 0, 30, 60, 120, 180 and 240 min at both visits). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.