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

Diet Clinical Trial

— MAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816579
• Other study ID #: 18-0147
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: December 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet
• Protein
• Skeletal Muscle

Intervention

Other:
• PRO-A
30 g of beef protein will be consumed at each meal
• PRO-B
30 g of complementary proteins will be consumed at each meal
• PRO-C
30 g of complementary proteins will be consumed over 24 hours

Locations

Country	Name	City	State
United States	Unversity of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute muscle protein synthesis: PRO-A	Muscle protein synthesis response to PRO-A breakfast meal (%/h)	3 hours after consuming meal
Primary	Acute muscle protein synthesis: PRO-B	Muscle protein synthesis response to PRO-B breakfast meal (%/h)	3 hours after consuming meal
Primary	Acute muscle protein synthesis: PRO-C	Muscle protein synthesis response to PRO-C breakfast meal (%/h)	3 hours after consuming meal
Primary	Acute muscle protein synthesis: CON	Muscle protein synthesis response to CON breakfast meal (%/hour)	3 hours after consuming meal
Primary	24-hour muscle protein synthesis: PRO-A	Muscle protein synthesis response to PRO-A diet over 24 hours (%/hour)	Approximately 24 hours
Primary	24-hour muscle protein synthesis: PRO-B	Muscle protein synthesis response to PRO-B diet over 24 hours (%/hour)	Approximately 24 hours
Primary	24-hour muscle protein synthesis: PRO-C	Muscle protein synthesis response to PRO-C diet over 24 hours (%/hour)	Approximately 24 hours
Primary	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)	Approximately 5 hours
Primary	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)	Approximately 5 hours
Primary	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)	Approximately 5 hours
Primary	Blood amino acid response to diet: CON	Blood samples will be drawn to measure amino acid concentrations response to CON breakfast (µmol/L)	Approximately 5 hours
Secondary	Blood glucose response to diet: PRO-A	Blood samples will be drawn to measure blood glucose response to PRO-A diet (mg/dl)	Approximately 24 hours
Secondary	Blood glucose response to diet: PRO-B	Blood samples will be drawn to measure blood glucose response to PRO-B diet (mg/dl)	Approximately 24 hours
Secondary	Blood glucose response to diet: PRO-C	Blood samples will be drawn to measure blood glucose response to PRO-C diet (mg/dl)	Approximately 24 hours
Secondary	Blood glucose response to diet: CON	Blood samples will be drawn to measure blood glucose response to CON breakfast meal (mg/dl)	Approximately 5 hours
Secondary	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.	Approximately 8 hours
Secondary	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.	Approximately 8 hours
Secondary	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.	Approximately 8 hours
Secondary	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.	Approximately 5 hours
Secondary	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	Approximately 36 hours
Secondary	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	Approximately 36 hours
Secondary	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	Approximately 36 hours
Secondary	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	Approximately 36 hours
Secondary	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".	Approximately 8 hours
Secondary	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".	Approximately 8 hours
Secondary	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".	Approximately 8 hours
Secondary	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".	Approximately 5 hours