Gut MicrobiomeCHSNCT03967990
Corn and Heart Health Study
A study testing Refined cornmeal flour, 50/50 refined cornmeal-bran mix and Whole grain cornmeal flour in people with Gut Microbiome and Cholesterol, LDL, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Cholesterol, LDL, Cholesterol, HDL
- What is being tested?
- Refined cornmeal flour, 50/50 refined cornmeal-bran mix and Whole grain cornmeal flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c ≥ 120 mg/dL).
- Individuals with LDL-c > 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study.
Who cannot join
- recent weight fluctuations (> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism)
- use of supplements (antioxidants, fiber, botanicals)
- allergies to dairy, egg, wheat, corn or gluten
- use of antibiotics in the past 2-3 months
- use of lipid lowering medications
- regular physical activity ≥ 30 min/d for ≥ 5 days/wk
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- history of thyroid disorders, diabetes, heart disease, cancer, hepatitis, inflammatory conditions and/or gastrointestinal disorders which may impact gut function and metabolism
- anyone with a fear of needles or blood draws
- If female, women may not be pregnant or lactating during the study.
- Unwillingness to comply with study protocols will also result in exclusion from the study.
- Participants in this study will not be eligible if they are participating in other research studies at the same time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85007
About this study
Official title: Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
Read the detailed description
Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals.
Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.
Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.
- Conditions
- Gut Microbiome, Cholesterol, LDL, Cholesterol, HDL
- Being tested
- Refined cornmeal flour, 50/50 refined cornmeal-bran mix, Whole grain cornmeal flour
- Keywords
- cholesterol, gut microbiome, gut microbiota, dietary fiber, whole grain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refined cornmeal flourOther
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
50/50 refined cornmeal-bran mixOther
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins
Whole grain cornmeal flourOther
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
| Study group | Role | What they receive |
|---|---|---|
| refined-50/50-whole | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) whole grain cornmeal flour Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
| 50/50-whole-refined | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) whole grain cornmeal flour, followed by (3) refined cornmeal flour Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
| whole-refined-50/50 | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) refined cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
| refined-whole-50/50 | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) whole grain cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
| 50/50-refined-whole | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) refined cornmeal flour, followed by (3) whole grain cornmeal flour Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
| whole-50/50-refined | Experimental | 48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) refined cornmeal flour Receives: Other: Refined cornmeal flour; Other: 50/50 refined cornmeal-bran mix; Other: Whole grain cornmeal flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
Serum LDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention
Measured: 0 weeks, 4 weeks
HDL Cholesterol
Serum HDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention
Measured: 0 weeks, 4 weeks
Secondary outcomes (1)
Gut Microbiome Diversity
Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0 and 4 weeks for each cornmeal intervention. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured.
Measured: 0 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 Mar 2018
- Primary completion30 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- North American Millers Association - Corn Division
- Responsible party
- Sponsor
- Investigators
- Corrie M Whisner, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967990
- Sponsor's protocol ID
- STUDY00007518
- Acronym
- CHS
- Status last verified
- Feb 2024
- First submitted
- 28 May 2019
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liedike B, Khatib M, Tabarsi B, Harris M, Wilson SL, Ortega-Santos CP, Mohr AE, Vega-Lopez S, Whisner CM. Evaluating the Effects of Corn Flour Product Consumption on Cardiometabolic Outcomes and the Gut Microbiota in Adults with Elevated Cholesterol: A Randomized Crossover. J Nutr. 2024 Aug;154(8):2437-2447. doi: 10.1016/j.tjnut.2024.06.003. Epub 2024 Jun 14.
PubMed 38880174
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol
- ClinicalTrials.gov ID
- NCT03967990
- Acronym / sponsor ID
- CHS / STUDY00007518
- Conditions
- Gut Microbiome, Cholesterol, LDL, Cholesterol, HDL
- Keywords
- cholesterol, gut microbiome, gut microbiota, dietary fiber, whole grain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- North American Millers Association - Corn Division
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 30 May 2019 (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 this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
Detailed description
Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals.
Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.
Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| refined-50/50-whole | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) whole grain cornmeal flour |
| 50/50-whole-refined | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) whole grain cornmeal flour, followed by (3) refined cornmeal flour |
| whole-refined-50/50 | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) refined cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran |
| refined-whole-50/50 | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) whole grain cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran |
| 50/50-refined-whole | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) refined cornmeal flour, followed by (3) whole grain cornmeal flour |
| whole-50/50-refined | Experimental | Other: Refined cornmeal flour, Other: 50/50 refined cornmeal-bran mix, Other: Whole grain cornmeal flour48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) refined cornmeal flour |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c ≥ 120 mg/dL).
- Individuals with LDL-c > 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study.
Key exclusion criteria (11 listed)
- recent weight fluctuations (> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism)
- use of supplements (antioxidants, fiber, botanicals)
- allergies to dairy, egg, wheat, corn or gluten
- use of antibiotics in the past 2-3 months
- use of lipid lowering medications
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 cornmeal flour48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins | Other | 50/50-refined-whole, 50/50-whole-refined, refined-50/50-whole, refined-whole-50/50, whole-50/50-refined, whole-refined-50/50 |
| 50/50 refined cornmeal-bran mix48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins | Other | 50/50-refined-whole, 50/50-whole-refined, refined-50/50-whole, refined-whole-50/50, whole-50/50-refined, whole-refined-50/50 |
| Whole grain cornmeal flour48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins | Other | 50/50-refined-whole, 50/50-whole-refined, refined-50/50-whole, refined-whole-50/50, whole-50/50-refined, whole-refined-50/50 |
Primary outcome
LDL Cholesterol
Time frame: 0 weeks, 4 weeks
Serum LDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention
HDL Cholesterol
Time frame: 0 weeks, 4 weeks
Serum HDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention
1 secondary outcome
Gut Microbiome Diversity
Time frame: 0 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 38880174Liedike B, Khatib M, Tabarsi B, Harris M, Wilson SL, Ortega-Santos CP, Mohr AE, Vega-Lopez S, Whisner CM. Evaluating the Effects of Corn Flour Product Consumption on Cardiometabolic Outcomes and the Gut Microbiota in Adults with Elevated Cholesterol: A Randomized Crossover. J Nutr. 2024 Aug;154(8):2437-2447. doi: 10.1016/j.tjnut.2024.06.003. Epub 2024 Jun 14.
- 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.
Corrie M Whisner, PhD principal investigator
Arizona State University
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 cornmeal flour, 50/50 refined cornmeal-bran mix and Whole grain cornmeal flour in people with Gut Microbiome and Cholesterol, LDL, run by Arizona State University 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LDL Cholesterol (time frame: 0 weeks, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967990, which also lists 1 linked publication.
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 5 Feb 2024.