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

March 22, 2013 updated by: AAstrup, University of Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg C
      • Copenhagen, Frederiksberg C, Denmark, 1958
        • Department of Human Nutrition, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Meal rich in dairy protein
Other: Dietary meal intervention
Test meals with different protein types (dairy versus meat)
Experimental: Meal rich in meat protein
Other: Dietary meal intervention
Test meals with different protein types (dairy versus meat)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
serum C-terminal carboxy-terminal collagen crosslinks (CTX)
Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
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
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
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
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
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
serum insulin-growth factor-1 (IGF-1)
Time Frame: at 0, 30, 60, 120, 180 and 240 min at both visits
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
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
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
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
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
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
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
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
at 0, 30, 60, 90, 120, 180 and 240 min at both visits

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
weight
Time Frame: at baseline at both visits
at baseline at both visits
height
Time Frame: at baseline at the first visit
at baseline at the first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danish Agriculture and Food Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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