Muscle Protein SynthesisMeaLNCT05151887
The Impact of a Whole-food Animal-based Versus Plant-based Protein Rich Meal on Muscle Protein Synthesis
A study testing Muscle protein synthesis in people with Muscle Protein Synthesis and Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis, Sarcopenia
- What is being tested?
- Muscle protein synthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jun 2021to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-85 years
- Body mass index 18.5 - 30 kg/m2
- Healthy
- Having given informed consent
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Muscle Protein Synthesis, Sarcopenia
- Being tested
- Muscle protein synthesis
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle protein synthesisOther
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
| Study group | Role | What they receive |
|---|---|---|
| Meat meal | Experimental | Minced beef, potato, string beans, apple sauce, and herb butter Receives: Other: Muscle protein synthesis |
| Plant meal | Experimental | Quinoa, soy beans, chickpeas, broad beans, and soy sauce Receives: Other: Muscle protein synthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis rates
Post-prandial muscle protein synthesis rates Meat meal vs Plant meal
Measured: One integrative value over the 6 hour post-prandial period
Secondary outcomes (4)
Muscle protein synthesis rates
Muscle protein synthesis rates during the basal period and over 0-3 hour and 3-6 hour period
Measured: -3-0 hour, 0-3 hour, and 3-6 hour
Plasma amino acid concentrations
Post-prandial plasma amino acid availability
Measured: 6 hour post-prandial period
Plasma glucose concentrations
Post-prandial plasma glucose availability
Measured: 6 hour post-prandial period
Plasma insulin concentrations
Post-prandial plasma insulin availability
Measured: 6 hour post-prandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start28 Jun 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff, Vion Food Group
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151887
- Sponsor's protocol ID
- METC 21-006
- Acronym
- MeaL
- Status last verified
- May 2023
- First submitted
- 15 Nov 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37972895
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05151887
- Acronym / sponsor ID
- MeaL / METC 21-006
- Conditions
- Muscle Protein Synthesis, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff, Vion Food Group
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meat meal | Experimental | Other: Muscle protein synthesisMinced beef, potato, string beans, apple sauce, and herb butter |
| Plant meal | Experimental | Other: Muscle protein synthesisQuinoa, soy beans, chickpeas, broad beans, and soy sauce |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65-85 years
- Body mass index 18.5 - 30 kg/m2
- Healthy
- Having given informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle protein synthesisThe 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 | Other | Meat meal, Plant meal |
Primary outcome
Muscle protein synthesis rates
Time frame: One integrative value over the 6 hour post-prandial period
Post-prandial muscle protein synthesis rates Meat meal vs Plant meal
4 secondary outcomes
Muscle protein synthesis rates
Time frame: -3-0 hour, 0-3 hour, and 3-6 hour
Plasma amino acid concentrations
Time frame: 6 hour post-prandial period
Plasma glucose concentrations
Time frame: 6 hour post-prandial period
Plasma insulin concentrations
Time frame: 6 hour post-prandial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 37972895Pinckaers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle protein synthesis in people with Muscle Protein Synthesis and Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis rates (time frame: One integrative value over the 6 hour post-prandial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.