Manipulation of Dietary Protein and the Anabolic Response (PRO-ADAPT)
Primary Purpose
Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High protein intake
Placebo comparator
Sponsored by
About this trial
This is an interventional basic science trial for Focus: Anabolic Response to Food Intake in Young Individuals focused on measuring Muscle protein synthesis, Dietary protein
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High protein intake
No protein intake
Arm Description
High protein intake: large bolus of protein in teh diet the day before testing
No protein in the diet the day before testing
Outcomes
Primary Outcome Measures
Muscle protein fractional synthetic rate following protein ingestion
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01820975
First Posted
March 18, 2013
Last Updated
March 21, 2017
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01820975
Brief Title
Manipulation of Dietary Protein and the Anabolic Response
Acronym
PRO-ADAPT
Official Title
The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
Keywords
Muscle protein synthesis, Dietary protein
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High protein intake
Arm Type
Experimental
Arm Description
High protein intake: large bolus of protein in teh diet the day before testing
Arm Title
No protein intake
Arm Type
Placebo Comparator
Arm Description
No protein in the diet the day before testing
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein intake
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Other Intervention Name(s)
control group
Intervention Description
No protein intake
Primary Outcome Measure Information:
Title
Muscle protein fractional synthetic rate following protein ingestion
Description
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.
Time Frame
3 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32069356
Citation
Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
Results Reference
derived
Learn more about this trial
Manipulation of Dietary Protein and the Anabolic Response
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