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Clinical Trials/NCT03816579
NCT03816579
Completed
Not 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 enrollmentMarch 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Protein
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
23
Locations
1
Primary Endpoint
Acute muscle protein synthesis: PRO-B
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2019
End Date
January 21, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

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

Study Sites (1)

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