Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Manipulation of Dietary Protein and the Anabolic Response (PRO-ADAPT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01820975
First received: March 18, 2013
Last updated: April 10, 2014
Last verified: April 2014
History of Changes
  Purpose

In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.


Condition Intervention
Focus: Anabolic Response to Food Intake in Young Individuals.
Condition Relevance: Skeletal Muscle Health, Sarcopenia.
 Dietary Supplement: High protein meals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men

Resource links provided by NLM:

MedlinePlus related topics: Dietary Proteins
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Muscle protein fractional synthetic rate following protein ingestion [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.
Estimated Enrollment: 28
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High protein intake
High protein intake: large bolus of protein in teh diet the day before testing
 Dietary Supplement: High protein meals
N/A
Placebo Comparator: No protein intake
No protein in the diet the day before testing

  Eligibility
Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males
  • Aged between 18-35 years
  • Healthy, recreationally active
  • BMI < 30 kg/m2

Exclusion Criteria:

  • Smoking
  • Allergies to milk proteins (whey or casein)
  • Vegetarians
  • Diagnosed GI tract diseases
  • Female
  • Arthritic conditions
  • A history of neuromuscular problems
  • Previous participation in amino acid tracer studies
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820975

Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01820975     History of Changes
Other Study ID Numbers: METC 12-3-067
Study First Received: March 18, 2013
Last Updated: April 10, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Muscle protein synthesis
Dietary protein

ClinicalTrials.gov processed this record on March 03, 2015