NCT01773304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

January 15, 2013

Last Update Submit

March 22, 2013

Conditions

ObesityBone Metabolism

Keywords

ObesityAdultsBone metabolismMetabolic profileDairy proteinMeat protein

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Other Outcomes (2)

  • weight

    at baseline at both visits

  • height

    at baseline at the first visit

Study Arms (2)

Meal rich in dairy protein

EXPERIMENTAL
Other: Dietary meal intervention

Meal rich in meat protein

EXPERIMENTAL
Other: Dietary meal intervention

Interventions

Dietary meal interventionOTHER

Test meals with different protein types (dairy versus meat)

Meal rich in dairy proteinMeal rich in meat protein

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females between 18 and 50 years
  • BMI 25-40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Med Sci

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

DK(1)