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

NCT03816579 | Completed

• 1 other identifier: 18-0147
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein; Diet; Skeletal Muscle

Outcome Measures

Primary Outcomes (11)

• Acute muscle protein synthesis: PRO-A

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

  3 hours after consuming meal

• Acute muscle protein synthesis: PRO-B

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

  3 hours after consuming meal

• Acute muscle protein synthesis: PRO-C

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

  3 hours after consuming meal

• Acute muscle protein synthesis: CON

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

  3 hours after consuming meal

• 24-hour muscle protein synthesis: PRO-A

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

  Approximately 24 hours

• 24-hour muscle protein synthesis: PRO-B

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

  Approximately 24 hours

• 24-hour muscle protein synthesis: PRO-C

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

  Approximately 24 hours

• 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

• 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

• 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

• 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 Outcomes (16)

• Blood glucose response to diet: PRO-A

  Approximately 24 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

Study Arms (4)

PRO-A

EXPERIMENTAL

Beef protein

Other: PRO-A

PRO-B

EXPERIMENTAL

Complementary proteins at each meal

Other: PRO-B

PRO-C

EXPERIMENTAL

Complementary proteins over 24 hours

Other: PRO-C

CON

NO INTERVENTION

Low protein (\<5 g) meal

Interventions

PRO-A OTHER

30 g of beef protein will be consumed at each meal

PRO-A

PRO-B OTHER

30 g of complementary proteins will be consumed at each meal

PRO-B

PRO-C OTHER

30 g of complementary proteins will be consumed over 24 hours

PRO-C

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All races and ethnic backgrounds
• Men and women, age 45-60 years

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Unversity of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Arentson-Lantz EJ, Von Ruff Z, Connolly G, Albano F, Kilroe SP, Wacher A, Campbell WW, Paddon-Jones D. Meals Containing Equivalent Total Protein from Foods Providing Complete, Complementary, or Incomplete Essential Amino Acid Profiles do not Differentially Affect 24-h Skeletal Muscle Protein Synthesis in Healthy, Middle-Aged Women. J Nutr. 2024 Dec;154(12):3626-3638. doi: 10.1016/j.tjnut.2024.10.010. Epub 2024 Oct 11.

  PMID: 39396760 DERIVED

Study Officials

• Doug Paddon-Jones, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: March 26, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: April 29, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)