MAPP: A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03816579
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 4
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Protein; Diet; Skeletal Muscle	Other: PRO-A; Other: PRO-B; Other: PRO-C	N/A

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:

1. 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]

2. 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.

3. 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

4. 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.

5. 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

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
• Actual Study Start Date: Mar 26, 2019
• Actual Primary Completion Date: Jan 21, 2021
• Actual Study Completion Date: Jan 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRO-A Beef protein	Other: PRO-A; 30 g of beef protein will be consumed at each meal
Experimental: PRO-B Complementary proteins at each meal	Other: PRO-B; 30 g of complementary proteins will be consumed at each meal
Experimental: PRO-C Complementary proteins over 24 hours	Other: PRO-C; 30 g of complementary proteins will be consumed over 24 hours
No Intervention: CON Low protein (<5 g) meal

Outcome Measures

Primary Outcome Measures

1. Acute muscle protein synthesis: PRO-A [3 hours after consuming meal]

   Muscle protein synthesis response to PRO-A breakfast meal (%/h)

2. Acute muscle protein synthesis: PRO-B [3 hours after consuming meal]

   Muscle protein synthesis response to PRO-B breakfast meal (%/h)

3. Acute muscle protein synthesis: PRO-C [3 hours after consuming meal]

   Muscle protein synthesis response to PRO-C breakfast meal (%/h)

4. Acute muscle protein synthesis: CON [3 hours after consuming meal]

   Muscle protein synthesis response to CON breakfast meal (%/hour)

5. 24-hour muscle protein synthesis: PRO-A [Approximately 24 hours]

   Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)

6. 24-hour muscle protein synthesis: PRO-B [Approximately 24 hours]

   Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)

7. 24-hour muscle protein synthesis: PRO-C [Approximately 24 hours]

   Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)

8. Blood amino acid response to diet: PRO-A [Approximately 5 hours]

   Blood samples will be drawn to measure amino acid concentrations response to PRO-A breakfast (µmol/L)

9. Blood amino acid response to diet: PRO-B [Approximately 5 hours]

   Blood samples will be drawn to measure amino acid concentrations response to PRO-B breakfast (µmol/L)

10. Blood amino acid response to diet: PRO-C [Approximately 5 hours]

    Blood samples will be drawn to measure amino acid concentrations response to PRO-B C breakfast (µmol/L)

11. Blood amino acid response to diet: CON [Approximately 5 hours]

    Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)

Secondary Outcome Measures

1. Blood glucose response to diet: PRO-A [Approximately 24 hours]

   Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)

2. Blood glucose response to diet: PRO-B [Approximately 24 hours]

   Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)

3. Blood glucose response to diet: PRO-C [Approximately 24 hours]

   Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)

4. Blood glucose response to diet: CON [Approximately 5 hours]

   Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)

5. Appetite and Hedonic Questionnaire: PRO-A [Approximately 8 hours]

   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.

6. Appetite and Hedonic Questionnaire: PRO-B [Approximately 8 hours]

   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.

7. Appetite and Hedonic Questionnaire: PRO-C [Approximately 8 hours]

   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.

8. Appetite and Hedonic Questionnaire: CON [Approximately 5 hours]

   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.

9. 3 day dietary record: PRO-A [Approximately 36 hours]

   Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-A study visit

10. 3 day dietary record: PRO-B [Approximately 36 hours]

    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-B study visit

11. 3 day dietary record: PRO-C [Approximately 36 hours]

    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to PRO-C study visit

12. 3 day dietary record: CON [Approximately 36 hours]

    Diet records will be collected and analyzed with ASA24 to assess habitual energy intake the week prior to CON study visit

13. Palatability Questionnaire:PRO-A [Approximately 8 hours]

    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".

14. Palatability Questionnaire:PRO-B [Approximately 8 hours]

    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".

15. Palatability Questionnaire:PRO-C [Approximately 8 hours]

    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".

16. Palatability Questionnaire:CON [Approximately 5 hours]

    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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. All races and ethnic backgrounds

2. Men and women, age 45-60 years

3. Generally healthy (see exclusion criteria)

4. Able and willing to provide informed consent

5. 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)

Exclusion Criteria:

1. Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))

2. Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)

3. Peripheral vascular disease

4. Pulmonary disease

5. History of systemic or pulmonary embolus

6. Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)

7. Impaired renal function (creatinine >1.5 mg/dl)

8. Anemia (hematocrit <33)

9. Untreated thyroid disease (abnormal TSH)

10. A recent history (<12 months) of GI bleed

11. Diabetes mellitus or other untreated endocrine or metabolic disease

12. Electrolyte abnormalities

13. Any history of stroke, hypo- or hyper-coagulation disorders

14. Recent (3 years) treated cancer other than basal cell carcinoma

15. Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months

16. Recent (6 months) adherence to a weight-loss or weight-gain diet

17. Weight change of 5% or more in previous 6 months

18. Body mass index >30 or excess body fat that compromises muscle biopsy collection

19. Body mass index <20 or recent history (<12 month) of disordered eating

20. Dietary preferences or practices that preclude the consumption of the study meals

21. Acute infectious disease or chronic infection

22. Alcohol or drug abuse

23. Any other condition or event considered exclusionary by study physician

24. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unversity of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

• The University of Texas Medical Branch, Galveston

Investigators

• Principal Investigator: Doug Paddon-Jones, PhD, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03816579
• Other Study ID Numbers: 18-0147
• First Posted: Jan 25, 2019
• Last Update Posted: Apr 29, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 29, 2021