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Effect of FoodPRO-CORNNCT06662214

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

A study testing Refined maize flour and Whole grain flour in people with Effect of Food, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Effect of Food
What is being tested?
Refined maize flour and Whole grain flour
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Feb 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC Davis CTSC Clinical Research Center

    Sacramento, California, 95817

Other trials in United States

About this study

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.

Read the detailed description

Indicators of longevity in humans include skeletal muscle mass and strength. Muscle mass is determined by the balance between myofibrillar protein synthesis and degradation, influenced by diet and physical activity. Muscle strength is closely tied to muscle mass, and activities like weight lifting until failure have been shown to increase muscle protein synthesis, enhancing muscle mass and strength over time. Protein intake is essential for maintaining a positive protein balance and promoting muscle growth. While animal proteins are generally more effective than plant proteins at promoting muscle protein synthesis, many cultures rely on staple plant-based foods, such as maize, rather than animal-based protein sources.

Maize (Zea mays) flour is a leading staple in African diets, where it is consumed in various forms, including porridges and breads like Ugali in East Africa or Fufu in West Africa. The nutritional profile of this corn bread varies greatly depending on whether it is made with refined or whole-grain maize flour. Whole-grain maize flour retains the bran, germ, and endosperm, providing higher fiber, vitamins, and minerals, while refined maize flour primarily contains the endosperm. Although refined maize is lower in fiber, it has a higher proportion of the leucine-rich zein, a major corn protein. These nutritional differences could significantly impact metabolism and overall health.

Given that approximately a fifth of the global population relies on corn meal as a dietary staple, understanding the impact of refined versus whole-grain maize flour on muscle protein synthesis and serum amino acid content could provide valuable insights for dietary guidelines and public health. This study aims to explore these effects, comparing the post-meal nutrient profile and muscle protein synthesis response to traditional African corn bread made with whole-grain versus refined maize flour.

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 servings of traditional African corn bread made from whole-grain or refined maize flour, paired with mung bean stew.

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.

Study participants will attend the CTSC Clinical Research Center on two separate occasions.

The two study visits will be scheduled over a 2-week period (i.e., once per week for 2 weeks) at the same time in the morning after an overnight fast of more than 12 hours. Participants will be asked to refrain from vigorous exercise, caffeine, nicotine, and alcohol for 24 hours before each visit. Female participants will schedule their visits within the first two weeks of their menstrual cycle to control for hormone fluctuations that may affect digestion and metabolism.

Upon arrival at the research center for the first test visit, each participant's height and weight will be measured. They will also complete a questionnaire covering their physical activity and dietary habits.

  1. Baseline blood draw.

Participants will be seated in individual testing rooms equipped with reclining phlebotomy armchairs. A nurse will insert a 22G catheter into a forearm vein to collect an initial 5 mL baseline blood sample.

II. Test meal.

After baseline blood collection, participants will consume one of the two corn bread test meals. The meal consists of a serving of mung bean stew and an isonitrogenous amount of either whole-grain or refined maize flour-based corn bread:

The food will be weighed before cooking, and an eighth of a teaspoon of salt will be added to enhance palatability and participants will be asked to consume the meal within a 10-minute period, chewing thoroughly. Participants will also drink a 250 mL glass of water with the meal.

III. Postprandial blood draws.

After the test meal, participants will remain at the research site in their testing rooms for 3 hours, where they may bring books or electronic devices to occupy themselves. Five additional 5 mL blood samples will be collected at 30, 60, 90, 120, and 180 minutes post-meal, totaling 30 mL per visit, and 60 mL for participants completing the study.

Blood samples will be collected in 5 mL serum-separating tubes. Samples will clot before centrifugation at 1000 x g for 10 minutes. The serum will then be frozen and stored at -80°C. One milliliter from each serum sample will be used to determine nutrient and hormone concentrations. The remainder will be used for muscle protein synthesis and mTORC1 bioassay analysis.

Conditions
Effect of Food
Being tested
Refined maize flour, Whole grain flour
Keywords
muscle protein synthesis, post-prandial nutrient and hormonal profile, farming practices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Refined maize flourOther

    Meal made form refined maize flour

  • Whole grain flourOther

    Meal made form whole grain maize flour

Study groups in NCT06662214
Study groupRoleWhat they receive
Refined maize flourExperimentalThis 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
Receives: Other: Refined maize flour
Whole grain flourExperimentalThis 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
Receives: Other: Whole grain flour

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start24 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06662214
Sponsor's protocol ID
2224550
Acronym
PRO-CORN
Status last verified
Oct 2026
First submitted
25 Oct 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Refined maize flour and Whole grain flour in people with Effect of Food, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post-prandial amino acid profile (time frame: [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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