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.
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
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.
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Whole grain flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
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]
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]
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.
- First posted28 Oct 2024
- Study start24 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of FoodStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Baar, Principal investigator, University of California, Davis
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrient Profile and Muscle Protein Synthesis in Response to Corn Bread Made From Refined Versus Whole Grain Maize Flour
- ClinicalTrials.gov ID
- NCT06662214
- Acronym / sponsor ID
- PRO-CORN / 2224550
- Conditions
- Effect of Food
- Keywords
- muscle protein synthesis, post-prandial nutrient and hormonal profile, farming practices
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Refined maize flour | Experimental | Other: Refined maize flourThis 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 |
| Whole grain flour | Experimental | Other: Whole grain flourThis 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refined maize flourMeal made form refined maize flour | Other | Refined maize flour |
| Whole grain flourMeal made form whole grain maize flour | Other | Whole grain flour |
Primary outcome
post-prandial amino acid profile
Time frame: [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]
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.
post-prandial short peptide profile
Time frame: [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]
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.
Muscle protein synthesis
Time frame: [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]
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.
mTORC1 specific protein synthesis
Time frame: [Time Frame: Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal]
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Baar principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
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.