NCT05151887

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.

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

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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

June 28, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

November 15, 2021

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis rates

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

    One integrative value over the 6 hour post-prandial period

Secondary Outcomes (4)

  • Muscle protein synthesis rates

    -3-0 hour, 0-3 hour, and 3-6 hour

  • Plasma amino acid concentrations

    6 hour post-prandial period

  • Plasma glucose concentrations

    6 hour post-prandial period

  • Plasma insulin concentrations

    6 hour post-prandial period

Study Arms (2)

Meat meal

EXPERIMENTAL

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

Other: Muscle protein synthesis

Plant meal

EXPERIMENTAL

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

Other: Muscle protein synthesis

Interventions

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

Meat mealPlant meal

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Pinckaers PJ, Domic J, Petrick HL, Holwerda AM, Trommelen J, Hendriks FK, Houben LH, Goessens JP, van Kranenburg JM, Senden JM, de Groot LC, Verdijk LB, Snijders T, van Loon LJ. Higher Muscle Protein Synthesis Rates Following Ingestion of an Omnivorous Meal Compared with an Isocaloric and Isonitrogenous Vegan Meal in Healthy, Older Adults. J Nutr. 2024 Jul;154(7):2120-2132. doi: 10.1016/j.tjnut.2023.11.004. Epub 2023 Nov 15.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Luc van Loon, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 9, 2021

Study Start

June 28, 2021

Primary Completion

April 25, 2022

Study Completion

April 25, 2022

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations