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Clinical Trials/NCT03816579
NCT03816579CompletedNot Applicable

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

The University of Texas Medical Branch, Galveston1 site in 1 country23 target enrollmentStarted: March 26, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Acute muscle protein synthesis: PRO-B

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)
  • Exclusion Criteria:
  • 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)
  • 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

Arms & Interventions

PRO-A

Experimental

Beef protein

Intervention: PRO-A (Other)

PRO-B

Experimental

Complementary proteins at each meal

Intervention: PRO-B (Other)

PRO-C

Experimental

Complementary proteins over 24 hours

Intervention: PRO-C (Other)

CON

No Intervention

Low protein (<5 g) meal

Outcomes

Primary Outcomes

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-A

Time Frame: 3 hours after consuming meal

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

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)

24-hour muscle protein synthesis: PRO-B

Time Frame: Approximately 24 hours

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

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-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-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)

Acute muscle protein synthesis: PRO-C

Time Frame: 3 hours after consuming meal

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

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)

Secondary Outcomes

  • Blood glucose response to diet: PRO-A(Approximately 24 hours)
  • 3 day dietary record: CON(Approximately 36 hours)
  • Palatability Questionnaire:CON(Approximately 5 hours)
  • Blood glucose response to diet: PRO-B(Approximately 24 hours)
  • Blood glucose response to diet: PRO-C(Approximately 24 hours)
  • Blood glucose response to diet: CON(Approximately 5 hours)
  • Appetite and Hedonic Questionnaire: PRO-A(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: PRO-B(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: CON(Approximately 5 hours)
  • 3 day dietary record: PRO-A(Approximately 36 hours)
  • Palatability Questionnaire:PRO-C(Approximately 8 hours)
  • Appetite and Hedonic Questionnaire: PRO-C(Approximately 8 hours)
  • 3 day dietary record: PRO-B(Approximately 36 hours)
  • 3 day dietary record: PRO-C(Approximately 36 hours)
  • Palatability Questionnaire:PRO-A(Approximately 8 hours)
  • Palatability Questionnaire:PRO-B(Approximately 8 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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