search
Back to results

Habitual Protein Intake and Muscle Protein Synthesis (Pro-Hab)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Protein diet
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Muscle protein synthesis, Digestion and absorption kinetics, Leucine, Whey protein

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy males
  • Age between 55 and 75 y
  • BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

  • Lactose intolerance
  • Smoking and alcohol abuse
  • Diabetes
  • Diagnosed GI tract diseases
  • Arthritic conditions
  • A history of neuromuscular problems
  • Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • Use of anticoagulants
  • Participation in exercise program
  • Hypertension, high blood pressure that is above 140/90 mmHg.

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low protein

High protein

Arm Description

Subject will receive a low protein diet (0.7 g/kg BW/day) for 14 days prior to the experimental trial

Subjects will receive a high protein diet (1.5 g/kg BW/day) for 14 days prior to the experimental trial

Outcomes

Primary Outcome Measures

Muscle protein synthesis rates
Change in MPS rates during the postprandial phase when compared with the basal phase

Secondary Outcome Measures

Digestion/Absorption kinetics
Difference in digestion of the intrinsically labeled protein after a 14-day period of high vs. low protein diet

Full Information

First Posted
November 12, 2013
Last Updated
November 27, 2014
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01986842
Brief Title
Habitual Protein Intake and Muscle Protein Synthesis
Acronym
Pro-Hab
Official Title
The Impact of Habitual Dietary Protein Intake on the Anabolic Response in Elderly Men
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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
Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining skeletal muscle mass with aging, it is important to optimize the adaptive response to food intake. However, a paucity of information is available describing the effects of habitual dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle protein synthesis after protein ingestion. The aim of this study is to investigate the effect of a habitual (14 days) high protein diet when compared with low protein diet on digestion and absorption kinetics and the subsequent muscle protein synthetic response to dietary protein ingestion.
Detailed Description
During the adult life skeletal muscle mass remains fairly constant until the fourth or fifth decade. Then, the slow process of sarcopenia (the age-related loss of muscle mass) is believed to begin. The maintenance of skeletal muscle mass is regulated by a balance between the opposing processes of muscle protein synthesis and muscle protein breakdown. Food intake, dietary protein in particular, stimulates muscle protein synthesis and allows net muscle protein accretion throughout the day, which allows the normal maintenance of muscle mass in healthy individuals. Many studies have described the postprandial muscle protein synthetic response to protein intake and/or physical activity, and these acute findings have led to recommendations for protein intake for both athletes wishing to gain muscle mass as well as patients and elderly individuals to help them maintaining muscle mass. However, translating the acute findings from a single meal to long-term recommendations is perhaps premature, since scientists know very little with regard to how previous consumed meals affect the anabolic responsiveness to subsequent food intake. A characteristic of the adaptation to habitual high or low protein intake is thought to be associated with a change in the amplitude of diurnal cycle of whole body proteins. If this speculation is accurate, it implies that the muscle protein synthetic responses to feeding (differences between fasting and feeding muscle protein synthesis rates) are adapting to differing habitual protein intake, which may reduce (or enhance) the anabolic responsiveness to protein intake. To gain a more complete scientific understanding, it is necessary to examine whether an adaptation does in fact occur after habitual high or low amounts of protein intake with regard to the anabolic response to subsequent protein intake. In the present investigation, we wish to investigate the impact of the habitual consumption of either high or low protein diets for 14 days on the anabolic responsiveness to a protein meal in healthy elderly. Previous work has determined that whole body adaptations to protein intake occur after >10 days. Collectively, our findings will be valuable to maximize the skeletal muscle adaptive response to food intake and, ultimately, to develop nutritional strategies for maintenance or enhancement of skeletal muscle mass in elderly men.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Muscle protein synthesis, Digestion and absorption kinetics, Leucine, Whey protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low protein
Arm Type
Experimental
Arm Description
Subject will receive a low protein diet (0.7 g/kg BW/day) for 14 days prior to the experimental trial
Arm Title
High protein
Arm Type
Experimental
Arm Description
Subjects will receive a high protein diet (1.5 g/kg BW/day) for 14 days prior to the experimental trial
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein diet
Intervention Description
Subjects will receive either a low protein or a high protein diet for 14 days. High protein will be realized with protein supplements.
Primary Outcome Measure Information:
Title
Muscle protein synthesis rates
Description
Change in MPS rates during the postprandial phase when compared with the basal phase
Time Frame
0-5 h postprandial period
Secondary Outcome Measure Information:
Title
Digestion/Absorption kinetics
Description
Difference in digestion of the intrinsically labeled protein after a 14-day period of high vs. low protein diet
Time Frame
0-5 h postprandial period
Other Pre-specified Outcome Measures:
Title
Plasma insulin
Time Frame
0-5 h postprandial period
Title
Plasma amino acid concentrations
Time Frame
0-5 h postprandial period
Title
Whole-body protein metabolism
Description
Protein metabolism (breakdown, synthesis, oxidation, net balance)
Time Frame
0-5 h postprandial period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males Age between 55 and 75 y BMI between 18.5 and 30 kg/m2 Exclusion Criteria: Lactose intolerance Smoking and alcohol abuse Diabetes Diagnosed GI tract diseases Arthritic conditions A history of neuromuscular problems Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications). Use of anticoagulants Participation in exercise program Hypertension, high blood pressure that is above 140/90 mmHg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands

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
PubMed Identifier
27903518
Citation
Gorissen SH, Horstman AM, Franssen R, Kouw IW, Wall BT, Burd NA, de Groot LC, van Loon LJ. Habituation to low or high protein intake does not modulate basal or postprandial muscle protein synthesis rates: a randomized trial. Am J Clin Nutr. 2017 Feb;105(2):332-342. doi: 10.3945/ajcn.115.129924. Epub 2016 Nov 30.
Results Reference
derived

Learn more about this trial

Habitual Protein Intake and Muscle Protein Synthesis

We'll reach out to this number within 24 hrs