ProteinMAPPNCT03816579
A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
A study testing PRO-A, PRO-B and PRO-C in people with Protein and Diet, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein, Diet, Skeletal Muscle
- What is being tested?
- PRO-A, PRO-B and PRO-C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 21 Jan 2021
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All races and ethnic backgrounds
- Men and women, age 45-60 years
- Generally healthy (see exclusion criteria)
- Able and willing to provide informed consent
- Ability to speak and read English (* the study procedures, e.g., muscle biopsy, duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires require sound written and spoken English)
Who cannot join
- Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))
- Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
- Peripheral vascular disease
- Pulmonary disease
- History of systemic or pulmonary embolus
- Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)
Show all 24Show fewer
- Impaired renal function (creatinine >1.5 mg/dl)
- Anemia (hematocrit <33)
- Untreated thyroid disease (abnormal TSH)
- A recent history (<12 months) of GI bleed
- Diabetes mellitus or other untreated endocrine or metabolic disease
- Electrolyte abnormalities
- Any history of stroke, hypo- or hyper-coagulation disorders
- Recent (3 years) treated cancer other than basal cell carcinoma
- Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months
- Recent (6 months) adherence to a weight-loss or weight-gain diet
- Weight change of 5% or more in previous 6 months
- Body mass index >30 or excess body fat that compromises muscle biopsy collection
- Body mass index <20 or recent history (<12 month) of disordered eating
- Dietary preferences or practices that preclude the consumption of the study meals
- Acute infectious disease or chronic infection
- Alcohol or drug abuse
- Any other condition or event considered exclusionary by study physician
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Texas Medical Branch
Galveston, Texas, 77555
About this study
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Secondly, the investigators will directly challenge a prevalent, but untested, assertion that has the potential to negatively impact health. The goal is to demonstrate that complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed at the same meal to stimulate protein synthesis.
Read the detailed description
The investigators will test the following hypotheses in middle-aged men and women (45-60) years old using a randomized, cross over design. All study objectives will be met concurrently:
- Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis [confirmatory hypothesis]
- Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein synthesis, but to a lesser extent than beef-protein.
- A single meal containing 30 g of an incomplete plant-based protein source (PRO-C: lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein synthesis
- Meals containing 30 g of plant-based protein that are incomplete at each separate meal, but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle protein synthesis.
- Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose [descriptive]
If these hypotheses are correct, the investigators will demonstrate that meals containing a moderate amount of high quality protein, such as beef, are an efficient and effective way to augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a prerequisite for outcomes related to physical function, performance, successful aging and metabolic health.
- Conditions
- Protein, Diet, Skeletal Muscle
- Being tested
- PRO-A, PRO-B, PRO-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-AOther
30 g of beef protein will be consumed at each meal
PRO-BOther
30 g of complementary proteins will be consumed at each meal
PRO-COther
30 g of complementary proteins will be consumed over 24 hours
| Study group | Role | What they receive |
|---|---|---|
| PRO-A | Experimental | Beef protein Receives: Other: PRO-A |
| PRO-B | Experimental | Complementary proteins at each meal Receives: Other: PRO-B |
| PRO-C | Experimental | Complementary proteins over 24 hours Receives: Other: PRO-C |
| CON | No intervention | Low protein (<5 g) meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute muscle protein synthesis: PRO-A
Muscle protein synthesis response to PRO-A breakfast meal (%/h)
Measured: 3 hours after consuming meal
Acute muscle protein synthesis: PRO-B
Muscle protein synthesis response to PRO-B breakfast meal (%/h)
Measured: 3 hours after consuming meal
Acute muscle protein synthesis: PRO-C
Muscle protein synthesis response to PRO-C breakfast meal (%/h)
Measured: 3 hours after consuming meal
Acute muscle protein synthesis: CON
Muscle protein synthesis response to CON breakfast meal (%/hour)
Measured: 3 hours after consuming meal
24-hour muscle protein synthesis: PRO-A
Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
Measured: Approximately 24 hours
24-hour muscle protein synthesis: PRO-B
Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
Measured: Approximately 24 hours
24-hour muscle protein synthesis: PRO-C
Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
Measured: Approximately 24 hours
Blood amino acid response to diet: PRO-A
Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
Measured: Approximately 5 hours
Blood amino acid response to diet: PRO-B
Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
Measured: Approximately 5 hours
Blood amino acid response to diet: PRO-C
Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
Measured: Approximately 5 hours
Blood amino acid response to diet: CON
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
Measured: Approximately 5 hours
Secondary outcomes (16)
Blood glucose response to diet: PRO-A
Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)
Measured: Approximately 24 hours
Blood glucose response to diet: PRO-B
Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)
Measured: Approximately 24 hours
Blood glucose response to diet: PRO-C
Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)
Measured: Approximately 24 hours
Blood glucose response to diet: CON
Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)
Measured: Approximately 5 hours
Appetite and Hedonic Questionnaire: PRO-A
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-A diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
Measured: Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-B
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-B diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
Measured: Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-C
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to PRO-C diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
Measured: Approximately 8 hours
Appetite and Hedonic Questionnaire: CON
Questionnaires will be given to assess hunger, fullness, desire to eat, thirst, desire to eat something sweet, desire to eat something salty, desire to eat something savory, sleepiness, physical energy, mental energy, and nausea in response to CON diet. All outcomes are scored individually on a 10 pt visual analog scale using "not at all" being 0 and "extremely" being a 10.
Measured: Approximately 5 hours
3 day dietary record: PRO-A
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit
Measured: Approximately 36 hours
3 day dietary record: PRO-B
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit
Measured: Approximately 36 hours
3 day dietary record: PRO-C
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit
Measured: Approximately 36 hours
3 day dietary record: CON
Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit
Measured: Approximately 36 hours
Palatability Questionnaire:PRO-A
Questionnaires will be given to assess palatability of the PRO-A diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
Measured: Approximately 8 hours
Palatability Questionnaire:PRO-B
Questionnaires will be given to assess palatability of the PRO-B diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
Measured: Approximately 8 hours
Palatability Questionnaire:PRO-C
Questionnaires will be given to assess palatability of the PRO-C diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
Measured: Approximately 8 hours
Palatability Questionnaire:CON
Questionnaires will be given to assess palatability of the CON diet. Outcomes include the participants ranking of the food appearance, aroma intensity, aroma, flavor intensity, flavor, texture and overall appeal of the food. A 10 pt visual analog scale will be used to assess the subject's response with 0 being "extremely dislike", 5 being "neither like nor dislike" and 10 being "extremely like".
Measured: Approximately 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start26 Mar 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
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 ProteinStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doug Paddon-Jones, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816579
- Sponsor's protocol ID
- 18-0147
- Acronym
- MAPP
- Status last verified
- Dec 2020
- First submitted
- 22 Jan 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arentson-Lantz EJ, Von Ruff Z, Connolly G, Albano F, Kilroe SP, Wacher A, Campbell WW, Paddon-Jones D. Meals Containing Equivalent Total Protein from Foods Providing Complete, Complementary, or Incomplete Essential Amino Acid Profiles do not Differentially Affect 24-h Skeletal Muscle Protein Synthesis in Healthy, Middle-Aged Women. J Nutr. 2024 Dec;154(12):3626-3638. doi: 10.1016/j.tjnut.2024.10.010. Epub 2024 Oct 11.
PubMed 39396760
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
- ClinicalTrials.gov ID
- NCT03816579
- Acronym / sponsor ID
- MAPP / 18-0147
- Conditions
- Protein, Diet, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 25 Jan 2019 (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.
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Secondly, the investigators will directly challenge a prevalent, but untested, assertion that has the potential to negatively impact health. The goal is to demonstrate that complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed at the same meal to stimulate protein synthesis.
Detailed description
The investigators will test the following hypotheses in middle-aged men and women (45-60) years old using a randomized, cross over design. All study objectives will be met concurrently:
- Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis [confirmatory hypothesis]
- Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein synthesis, but to a lesser extent than beef-protein.
- A single meal containing 30 g of an incomplete plant-based protein source (PRO-C: lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein synthesis
- Meals containing 30 g of plant-based protein that are incomplete at each separate meal, but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle protein synthesis.
- Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose [descriptive]
If these hypotheses are correct, the investigators will demonstrate that meals containing a moderate amount of high quality protein, such as beef, are an efficient and effective way to augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a prerequisite for outcomes related to physical function, performance, successful aging and metabolic health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRO-A | Experimental | Other: PRO-ABeef protein |
| PRO-B | Experimental | Other: PRO-BComplementary proteins at each meal |
| PRO-C | Experimental | Other: PRO-CComplementary proteins over 24 hours |
| CON | No intervention | –Low protein (<5 g) meal |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All races and ethnic backgrounds
- Men and women, age 45-60 years
- Generally healthy (see exclusion criteria)
- Able and willing to provide informed consent
- Ability to speak and read English (* the study procedures, e.g., muscle biopsy, duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires require sound written and spoken English)
Key exclusion criteria (24 listed)
- Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))
- Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
- Peripheral vascular disease
- Pulmonary disease
- History of systemic or pulmonary embolus
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 |
|---|---|---|
| PRO-A30 g of beef protein will be consumed at each meal | Other | PRO-A |
| PRO-B30 g of complementary proteins will be consumed at each meal | Other | PRO-B |
| PRO-C30 g of complementary proteins will be consumed over 24 hours | Other | PRO-C |
Primary outcome
Acute muscle protein synthesis: PRO-A
Time frame: 3 hours after consuming meal
Muscle protein synthesis response to PRO-A breakfast meal (%/h)
Acute muscle protein synthesis: PRO-B
Time frame: 3 hours after consuming meal
Muscle protein synthesis response to PRO-B breakfast meal (%/h)
Acute muscle protein synthesis: PRO-C
Time frame: 3 hours after consuming meal
Muscle protein synthesis response to PRO-C breakfast meal (%/h)
Acute muscle protein synthesis: CON
Time frame: 3 hours after consuming meal
Muscle protein synthesis response to CON breakfast meal (%/hour)
24-hour muscle protein synthesis: PRO-A
Time frame: Approximately 24 hours
Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)
24-hour muscle protein synthesis: PRO-B
Time frame: Approximately 24 hours
Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)
24-hour muscle protein synthesis: PRO-C
Time frame: Approximately 24 hours
Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)
Blood amino acid response to diet: PRO-A
Time frame: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)
Blood amino acid response to diet: PRO-B
Time frame: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)
Blood amino acid response to diet: PRO-C
Time frame: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)
Blood amino acid response to diet: CON
Time frame: Approximately 5 hours
Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)
16 secondary outcomes
Blood glucose response to diet: PRO-A
Time frame: Approximately 24 hours
Blood glucose response to diet: PRO-B
Time frame: Approximately 24 hours
Blood glucose response to diet: PRO-C
Time frame: Approximately 24 hours
Blood glucose response to diet: CON
Time frame: Approximately 5 hours
Appetite and Hedonic Questionnaire: PRO-A
Time frame: Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-B
Time frame: Approximately 8 hours
Appetite and Hedonic Questionnaire: PRO-C
Time frame: Approximately 8 hours
Appetite and Hedonic Questionnaire: CON
Time frame: Approximately 5 hours
3 day dietary record: PRO-A
Time frame: Approximately 36 hours
3 day dietary record: PRO-B
Time frame: Approximately 36 hours
3 day dietary record: PRO-C
Time frame: Approximately 36 hours
3 day dietary record: CON
Time frame: Approximately 36 hours
Palatability Questionnaire:PRO-A
Time frame: Approximately 8 hours
Palatability Questionnaire:PRO-B
Time frame: Approximately 8 hours
Palatability Questionnaire:PRO-C
Time frame: Approximately 8 hours
Palatability Questionnaire:CON
Time frame: Approximately 5 hours
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 29 Apr 2021.
- Derived from this study: PubMed 39396760Arentson-Lantz EJ, Von Ruff Z, Connolly G, Albano F, Kilroe SP, Wacher A, Campbell WW, Paddon-Jones D. Meals Containing Equivalent Total Protein from Foods Providing Complete, Complementary, or Incomplete Essential Amino Acid Profiles do not Differentially Affect 24-h Skeletal Muscle Protein Synthesis in Healthy, Middle-Aged Women. J Nutr. 2024 Dec;154(12):3626-3638. doi: 10.1016/j.tjnut.2024.10.010. Epub 2024 Oct 11.
- 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.
Doug Paddon-Jones, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO-A, PRO-B and PRO-C in people with Protein and Diet, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 5 inclusion and 24 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 29 Apr 2021. 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 United States. 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?
Acute muscle protein synthesis: PRO-A (time frame: 3 hours after consuming meal). The study lists 11 primary outcomes in all. 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 NCT03816579, 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 29 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.