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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2021-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle

NCT02787889

Sarcopenia

COMPLETED NA

Habitual Protein Intake and Muscle Protein Synthesis

NCT01986842

Sarcopenia

COMPLETED NA

The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females

NCT03571425

Healthy

COMPLETED NA

Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults

NCT05574205

Sarcopenia Dietary Protein Resistance Exercise

COMPLETED NA

Time Course of Postprandial Protein Metabolism

NCT04121689

Muscle Protein Synthesis Protein Metabolism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Protein Diet Skeletal Muscle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRO-A

Beef protein

Group Type EXPERIMENTAL

PRO-A

Intervention Type OTHER

30 g of beef protein will be consumed at each meal

PRO-B

Complementary proteins at each meal

Group Type EXPERIMENTAL

PRO-B

Intervention Type OTHER

30 g of complementary proteins will be consumed at each meal

PRO-C

Complementary proteins over 24 hours

Group Type EXPERIMENTAL

PRO-C

Intervention Type OTHER

30 g of complementary proteins will be consumed over 24 hours

CON

Low protein (\<5 g) meal

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRO-A

30 g of beef protein will be consumed at each meal

Intervention Type OTHER

PRO-B

30 g of complementary proteins will be consumed at each meal

Intervention Type OTHER

PRO-C

30 g of complementary proteins will be consumed over 24 hours

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. All races and ethnic backgrounds
2. Men and women, age 45-60 years

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)

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes