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The Impact of a Whole-food Animal-based Versus Plant-based Protein Rich Meal on Muscle Protein Synthesis (MeaL)

Primary Purpose

Muscle Protein Synthesis, Sarcopenia

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

About this trial

This is an interventional prevention trial for Muscle Protein Synthesis

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 65-85 years
  • Body mass index 18.5 - 30 kg/m2
  • Healthy
  • Having given informed consent

Exclusion Criteria:

  • Allergy for one of the food items used
  • >5% weight change in the previous 6 months
  • Participating in a structured (progressive) exercise program
  • Smoking
  • Diagnosed musculoskeletal disorders
  • Diagnosed metabolic disorders (e.g. diabetes)
  • Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
  • Chronic use of gastric acid suppressing medication
  • Chronic use of anti-coagulants
  • Diagnosed GI tract disorders or diseases
  • Blood donation in the past 2 months
  • Strict vegetarian diet

Sites / Locations

  • Maastricht University Medical Center+

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Meat meal

Plant meal

Arm Description

Minced beef, potato, string beans, apple sauce, and herb butter

Quinoa, soy beans, chickpeas, broad beans, and soy sauce

Outcomes

Primary Outcome Measures

Muscle protein synthesis rates
Post-prandial muscle protein synthesis rates Meat meal vs Plant meal

Secondary Outcome Measures

Muscle protein synthesis rates
Muscle protein synthesis rates during the basal period and over 0-3 hour and 3-6 hour period
Plasma amino acid concentrations
Post-prandial plasma amino acid availability
Plasma glucose concentrations
Post-prandial plasma glucose availability
Plasma insulin concentrations
Post-prandial plasma insulin availability

Full Information

First Posted
November 15, 2021
Last Updated
May 30, 2023
Sponsor
Maastricht University Medical Center
Collaborators
National Cattlemen's Beef Association, Vion Food Group
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1. Study Identification

Unique Protocol Identification Number
NCT05151887
Brief Title
The Impact of a Whole-food Animal-based Versus Plant-based Protein Rich Meal on Muscle Protein Synthesis
Acronym
MeaL
Official Title
The Impact of Ingesting a Whole-food Animal-based Versus Plant-based Protein Rich Meal on the Muscle Protein Synthetic Response in Healthy Older Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
National Cattlemen's Beef Association, Vion Food Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: Food intake stimulates muscle protein synthesis rates. The magnitude of the anabolic response to feeding forms a key factor in regulating muscle mass maintenance. Ingestion of animal-derived proteins generally leads to a greater stimulation of muscle protein synthesis when compared to the ingestion of plant-derived proteins. What is often neglected is that the anabolic properties of protein isolates do not necessarily reflect the anabolic response to the ingestion of the whole-foods from which those are derived. This discrepancy is due to the presence or absence of other components normally found within whole-food matrices, which influence protein digestion and amino acid absorption from animal based and plant based protein sources. A rapid and robust post-prandial release of food-derived amino acids is of particular relevance for older individuals, who typically show a blunted muscle protein synthetic response to feeding Objective: To compare the post-prandial muscle protein synthetic response following ingestion of a whole-food meal (560 kilo calorie (kCal); ~36 g protein total, ~0.45 g/kg body weight) containing ~100 g lean ground beef (~30 g protein) versus the ingestion of an isonitrogenous, isocaloric whole-food meal containing only plant-based protein sources (561 kCal; ~36 g protein total) in vivo in healthy, older men and women. Study design: randomized, counter-balanced, cross-over design, researchers and participants are not blinded, analysts are blinded. Study population: 16 healthy older (65-85 y) men and women (1:1 ratio of men:women) Intervention: Participants will undergo 2 test days. On one test day participants will consume a whole-food meal containing meat as the primary source of protein (~36 g, ~0.45 g/kg body weight). On the other day, participants will consume a whole-food meal containing only plant-based foods as the source of protein (~36 g or ~0.45 g/kg body weight). In addition, a continuous intravenous tracer infusion will be applied, and blood an muscle samples will be collected in order to assess the muscle protein synthetic response. Main study parameters/endpoints: The primary endpoint will be mixed muscle protein synthesis rates over the full 6h post-prandial period following meal ingestion.
Detailed Description
Food intake stimulates muscle protein synthesis rates. The anabolic response to feeding forms a key factor in regulating muscle mass maintenance. Impairments in the sensitivity of skeletal muscle tissue to respond to the anabolic properties of protein feeding have been reported in numerous settings where muscle mass is being lost, such as aging, disuse, chronic metabolic disease, and various clinical conditions where muscle wasting is apparent. The capacity of a dietary protein to stimulate post-prandial muscle protein accretion depends on the digestion and absorption kinetics of that protein as well as its amino acid composition. A more rapid rise in circulating essential amino acids (EAAs), with leucine in particular, drives the post-prandial rise in muscle protein synthesis rates. It has been suggested that plant and animal based protein sources do not have the same anabolic properties due to differences digestibility and essential amino acid composition. However, so far, nearly all studies evaluating the muscle protein synthetic response to food ingestion have applied a reductionist approach and have determined the muscle protein synthetic response to the ingestion of isolated protein sources (e.g., whey, casein, soy) with or without other isolated meal components (e.g., carbohydrates, fats). This work suggests that the ingestion of isolated animal-based proteins stimulates a superior muscle protein synthetic response when compared to the ingestion of isolated plant-based proteins. However, protein isolates never constitute the main protein portion of a meal. Perhaps more importantly, it is often neglected that the anabolic properties of protein isolates do not necessarily reflect the anabolic response to the ingestion of the whole-foods from which those are derived. This discrepancy is due to the presence or absence of other nutritional components within whole-food matrices. In particular, plant-derived protein sources contain anti-nutritional factors that impair protein digestion and amino acid absorption and, as such, compromise the post-prandial rise in muscle protein synthesis rates. Therefore, this project will compare the impact of the ingestion of a whole-food meal with beef as the primary source of protein, with the ingestion of a whole food meal ingestion with only plant derived protein sources, on the muscle protein synthetic response in healthy older men and women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Protein Synthesis, Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The present study utilizes a randomized, counter-balanced, cross-over design in healthy older male and female participants. In total, 16 healthy older men and women (1:1 ratio of men:women) will participate in the study (20 including potential drop-out). Participants will be randomly assigned to either receive the meal including meat or exclusively plant based foods during the Test Day 1. During Test Day 2, participants will receive the other meal.
Masking
None (Open Label)
Masking Description
In this trial, neither the participants, nor the researchers who perform the trial days will be blinded to the intervention allocation. However, the researchers performing the sample analysis are blinded to intervention allocation and are not involved in the research study during the trial days.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meat meal
Arm Type
Experimental
Arm Description
Minced beef, potato, string beans, apple sauce, and herb butter
Arm Title
Plant meal
Arm Type
Experimental
Arm Description
Quinoa, soy beans, chickpeas, broad beans, and soy sauce
Intervention Type
Other
Intervention Name(s)
Muscle protein synthesis
Intervention Description
The meals contain a total of 0.45 g protein/kg body mass (36 g protein for an 80 kg person). To account for differences in body mass, the investigators will scale the meal content to ensure 0.45 g/kg body mass for different body mass ranges (i.e., 65-75 kg, 75-85 kg, etc.). As such, carbohydrate, fat, and total energy content of the meals will also be scaled to body mass. The test meals are composed out of regular whole food items which will be purchased from local shops. The muscle protein synthetic response following meal ingestion will be assessed by the use of stable isotope tracer methodology
Primary Outcome Measure Information:
Title
Muscle protein synthesis rates
Description
Post-prandial muscle protein synthesis rates Meat meal vs Plant meal
Time Frame
One integrative value over the 6 hour post-prandial period
Secondary Outcome Measure Information:
Title
Muscle protein synthesis rates
Description
Muscle protein synthesis rates during the basal period and over 0-3 hour and 3-6 hour period
Time Frame
-3-0 hour, 0-3 hour, and 3-6 hour
Title
Plasma amino acid concentrations
Description
Post-prandial plasma amino acid availability
Time Frame
6 hour post-prandial period
Title
Plasma glucose concentrations
Description
Post-prandial plasma glucose availability
Time Frame
6 hour post-prandial period
Title
Plasma insulin concentrations
Description
Post-prandial plasma insulin availability
Time Frame
6 hour post-prandial period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 65-85 years Body mass index 18.5 - 30 kg/m2 Healthy Having given informed consent Exclusion Criteria: Allergy for one of the food items used >5% weight change in the previous 6 months Participating in a structured (progressive) exercise program Smoking Diagnosed musculoskeletal disorders Diagnosed metabolic disorders (e.g. diabetes) Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories). Chronic use of gastric acid suppressing medication Chronic use of anti-coagulants Diagnosed GI tract disorders or diseases Blood donation in the past 2 months Strict vegetarian diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of a Whole-food Animal-based Versus Plant-based Protein Rich Meal on Muscle Protein Synthesis

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