Nutrient Profile and Muscle Protein Synthesis in Response to Corn Bread Made From Refined Versus Whole Grain Maize Flour

NCT06662214 | Active Not Recruiting

• 1 other identifier: 2224550
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to quantify and compare the serum nutrient and hormonal profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of a traditional East African meal, mung bean stew with a traditional African corn bread made from two different kinds of maize (whole corn flour or refined). Specific aim 1: Describe the post-prandial nutrient and hormonal profile in serum in the 3 hours following consumption of a portion of mung bean stew with traditional African corn bread made with either whole grain maize flour or refined maize flour. Specific aim 2: Compare the ability a portion of mung bean stew and traditional African corn bread made with either whole grain maize flour or refined maize flour to activate mTORC1-specific and whole muscle protein synthesis in an in vitro model of muscle.

Conditions

Effect of Food

Keywords

muscle protein synthesis; post-prandial nutrient and hormonal profile; farming practices

Outcome Measures

Primary Outcomes (4)

• post-prandial amino acid profile

  Serum samples are extracted with 1mL of modified Folch extraction, followed by vacuum centrifugation for drying. Dried samples will be reconstituted with 100 μl of 75% ACN/water. The supernatant is then injected into Aligent UPLC-QqQ for analysis of targeted free amino acids, short peptides, and other metabolites.

  [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]

• post-prandial short peptide profile

  Serum samples are extracted with 1mL of modified Folch extraction, followed by vacuum centrifugation for drying. Dried samples will be reconstituted with 100 μl of 75% ACN/water. The supernatant is then injected into Aligent UPLC-QqQ for analysis of targeted free amino acids, short peptides, and other metabolites.

  [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]

• Muscle protein synthesis

  To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 10% baseline or fed serum (from blood samples at 30, 60, 90,120 and 180 minutes after meal) for 3 hours. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

  [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]

• mTORC1 specific protein synthesis

  To measure the ability of meal of chicken (conventional or regenerative) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA, which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (from blood samples at 30, 60, 90,120 and 180 minutes after meal). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

  [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]

Study Arms (2)

Refined maize flour

EXPERIMENTAL

This arm will be given a meal of corn bread made from refined maize flour and a portion of the mung bean stew meat together with 250mL of water

Other: Refined maize flour

Whole grain flour

EXPERIMENTAL

This arm will be given a meal of corn bread made from whole grain maize flour and a portion of the mung bean stew meat together with 250mL of water

Other: Whole grain flour

Interventions

Refined maize flour OTHER

Meal made form refined maize flour

Refined maize flour

Whole grain flour OTHER

Meal made form whole grain maize flour

Whole grain flour

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy active males and females (To be considered active, volunteers must meet the following American College of Sports Medicine's guideline for physical activity for healthy adults: performing at least 150 minutes per week of moderate-to-vigorous intensity physical activity.
• Age18-30 years
• Normal weight (BMI between 18 and 25 kg/m2

You may not qualify if:

• Health or dietary restrictions that would prevent consumption of the test foods
• Known food allergy to corn
• Anemia (low red blood cell count)
• Overweight or obesity (BMI \> 25 kg/m2)
• Receiving any medication that may interfere with the study
• Metabolic or endocrine disorder that would affect the digestion, absorption, and/or physiological response to any of the nutrients ingested.
• Currently not meeting the ACSM physical activity recommendations (IPAQ score \< 150 min/week of moderate-to-vigorous physical activity.
• Pregnancy

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

Study Officials

• Keith Baar

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which food. The interventions will be coded using a blinded alphabetical letter code (A, B). A delegate researcher (independent party not further involved in the study) will randomize all interventions using a computer-generated randomization list. The delegate will hand in the code-breaker to the principal investigator in a sealed envelope. The envelope will be stored in a locked filing cabinet in the principal investigator's office, which will also be locked when unoccupied. The envelope will be opened by the principal investigator after completing the analysis of blood samples.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will consume a meal corn bread plus mung bean stew, which type (refined vs. whole grain) consumed will be randomized where neither the participant nor investigator will know which meal is being consumed. Each participant will repeat the protocol two times.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)