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Dietary InterventionNCT07832071

Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism

A study testing Whole grain sumac sorghum, Whole grain white sorghum and White rice in people with Dietary Intervention and Gut Microbiota, run by University of Nebraska Lincoln at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Sorghum is a nutrient-dense ancient grain that, when eaten as a whole grain, provides health-beneficial dietary fiber, protein, and phenolics. The goal of this clinical trial is to learn about the phenolic-dependent and independent effects of whole grain sorghum in adults with excess body weight. Read more about this study

Who is it for?
Ages 19 to 64 yearsHealthy volunteers can take part
What is being tested?
Whole grain sumac sorghum, Whole grain white sorghum and White rice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Oct 2026to Jul 2029
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 19 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between the age of 19 and 64 years.
  • Not currently pregnant or planning to become pregnant (females only).
  • Stable body mass index above or equal to 26 kg/m² (rounded up) for the last month.
  • Body fat above or equal to 36% (female) or 25% (male) (rounded up).
  • No major diet changes in the last month.
  • Ability to eat provided study foods each day and avoid eating sorghum except for the study foods.
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  • Ability to wear a continuous glucose monitor for 10 days.
  • Ability to have blood drawn after ~12 hours of fasting.
  • Have a bowel movement at least every third day.
  • Ability to collect and deliver your stool samples to the study site within 4 hours of collection.
  • No known allergies or intolerance to sorghum or rice.
  • No known allergies to wheat or soy (study foods may contain wheat or soy)
  • Able to read and speak English.
  • Requires no legally authorized representative (LAR).
  • Not institutionalized (e.g., prison, psychological treatment center, etc.).

Who cannot join

  • Has cardiac device or history of organ transplant.
  • History of cancer within the last year (excludes skin cancer).
  • History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines.
  • Current use of tobacco.
  • Excessing alcohol use (≥8 drinks [female] or ≥15 drinks [male] per week).
  • Taken antibiotics in the last 2 months.
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  • Current long-term use of anti-diabetic, anti-inflammatory, or cholesterol-lowering medications.
  • Medication regimen or dosage changed within the last 2 months.
  • Use of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements within the last 3 weeks.
  • Supplement regimen or dosage changed within the last 3 weeks

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edward C Deehan, PhD, RD contact

402-472-1862

edeehan2@unl.edu

United States1 site
  • Nebraska Food for Health Center

    Lincoln, Nebraska, 68588

    Edward C Deehan, PhD, RD, 402-472-1862, edeehan2@unl.edu

    Edward C Deehan, PhD, RD

Other trials in United States

About this study

Sorghum is a nutrient-dense ancient grain that, when eaten as a whole grain, provides health-beneficial dietary fiber, protein, and phenolics. The goal of this clinical trial is to learn about the phenolic-dependent and independent effects of whole grain sorghum in adults with excess body weight. The main questions it aims to answer are:

  • Are markers of immune and metabolic health affected differently by eating high- vs low-phenolic whole grain sorghum?
  • Does the gut microbiome respond differently to eating high- vs low-phenolic whole grain sorghum, and does this response explain the health effects?
Read more

Researchers will compare foods made from (1) whole grain sumac sorghum (high phenolic profile), (2) whole grain white sorghum (low phenolic profile), and (3) white rice (control) randomly to identify the health benefits of sorghum relative to white rice.

Participants will:

  • Consume three study foods daily during three intervention phases, with each phase lasting four weeks. The three study foods will be a cereal, crispy breadstick, and grain pouch product, which will be made from one of the study grains (sumac sorghum, white sorghum, or white rice).
  • Complete questionnaires asking about demographic, diet, lifestyle, quality-of-life, health, and gut health information.
  • Have height, weight, waist circumference, body composition, and blood pressure measured.
  • Wear a continuous glucose monitor 3 times, each for 10 days.
  • Have six blood draws, one saliva sample collection, and provide six stool samples.
  • Maintain a study journal during the three intervention phases.
Read the detailed description

Whole grain sorghum is a nutrient-dense, climate-resilient cereal grain that contains dietary fiber, protein, and bioactive compounds such as phenolics, which may beneficially influence gut microbiota and host immunometabolism. However, evidence from well-controlled human randomized controlled trials (RCTs) remains limited, particularly regarding how sorghum varieties with distinct phenolic profiles differentially affect metabolic health and the gut microbiome.

This study is a randomized, three-phase crossover dietary intervention trial designed to evaluate the phenolic-dependent and independent effects of whole grain sorghum consumption in adults with excess body weight. Participants will consume foods made from (1) whole grain sumac sorghum (high phenolic profile), (2) whole grain white sorghum (low phenolic profile), and (3) white rice (control), in random order.

The study consists of a baseline phase of up to two weeks, followed by three 4-week intervention phases separated by washout periods of at least three weeks. During each intervention phase, participants will consume three study foods daily: ready-to-eat cereal, crispy breadsticks, and pre-cooked grain pouches, providing approximately 84 g/day of the study grain. Clinical, metabolic, and microbiome-related outcomes will be assessed through repeated biospecimen collection and questionnaires.

Being tested
Whole grain sumac sorghum, Whole grain white sorghum, White rice
Keywords
Nutritional Microbiology, Sorghum bicolor, Gut Microbiota
Medical subject headings
Insulin Resistance, Obesity, Overweight

What participants receive

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

  • Whole grain sumac sorghumOther

    Whole grain sumac sorghum consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g/day of whole grain (3 ounce servings).

  • Whole grain white sorghumOther

    Whole grain white sorghum consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g/day of whole grain (3 ounce servings).

  • White riceOther

    White rice consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g/day of refined grain (3 ounce servings).

Study groups in NCT07832071
Study groupRoleWhat they receive
Intervention Scheme 1Active comparatorIntervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice
Intervention Scheme 2Active comparatorIntervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice
Intervention Scheme 3Active comparatorIntervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice
Intervention Scheme 4Active comparatorIntervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice
Intervention Scheme 5Active comparatorIntervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice
Intervention Scheme 6Active comparatorIntervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch. Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch. Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Receives: Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

What is being measured

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

  1. Insulin resistance as estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

    Changes in circulating levels of glucose (Unit: mg/dL) and insulin (Unit: uIU/mL) when collected after fasting. Glucose and insulin values will then be used to calculate the Homeostasis Model Assessment of Insulin Resistance using the equation previously described by Matthews and colleagues.

    Measured: From baseline to the end of treatment at 4 weeks.

Secondary outcomes (10)
  1. Beta cell function as estimated by the Homeostatic Model Assessment for beta-cell function (HOMA-%B).

    Changes in circulating levels of glucose (Unit: mg/dL) and C-peptide (Unit: ng/mL) when collected after fasting. Glucose and C-peptide values will then be used to calculate the Homeostasis Model Assessment of beta-cell function using the equation previously described by Matthews and colleagues.

    Measured: From baseline to the end of treatment at 4 weeks.

  2. Interstitial glucose dynamics by continuous glucose monitoring

    Interstitial glucose dynamics (Unit: mg/dL) when assessed continuously over a 10 day period.

    Measured: Continuously over a 10 day period during the treatment weeks.

  3. Lipid metabolism assessed by a lipid panel

    Changes in circulating levels of total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides (Units: mg/dL) when collected after fasting.

    Measured: From baseline to the end of treatment at 4 weeks.

  4. Systematic inflammation assessed by C-reactive protein

    Changes in circulating levels of C-reactive protein (Unit: mg/L) when collected after fasting.

    Measured: From baseline to the end of treatment at 4 weeks.

  5. Systematic inflammation assessed by glycosylated acute-phase proteins (GlycA)

    Changes in circulating levels of glycosylated acute-phase proteins (Unit: umol/L) when collected after fasting.

    Measured: From baseline to the end of treatment at 4 weeks.

  6. Systematic inflammation assessed by interleukin-6

    Changes in circulating levels of interleukin-6 (Unit: pg/mL) when collected after fasting.

    Measured: From baseline to the end of treatment at 4 weeks.

  7. 16S rRNA gene amplicon sequencing of the fecal bacterial community

    Changes in bacterial composition in fecal samples, as assessed by 16S rRNA gene amplicon sequencing.

    Measured: From baseline to the end of treatment at 4 weeks.

  8. Fecal short-chain fatty acids assessed by gas chromatography

    Changes in fecal concentrations of short-chain fatty acids as determined by gas chromatography.

    Measured: From baseline to the end of treatment at 4 weeks.

  9. Fecal pH assessed by pH meter

    Changes in fecal pH as determined by pH meter.

    Measured: From baseline to the end of treatment at 4 weeks.

  10. Fecal dry mass assessed by oven-drying

    Changes in fecal dry mass as determined by oven-drying.

    Measured: From baseline to the end of treatment at 4 weeks.

Timeline

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

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionJul 2029 (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
The study intervention will consist of individuals consuming, on a daily basis, study foods made from whole grain sumac sorghum, whole grain white sorghum, or white rice over three 4-week intervention periods. The study foods will include ready-to-eat cereal, crispy breadsticks, and pre-cooked grain pouches. The study foods will provide approximately 84 g/day of the assigned study grain. Participants will be asked to consume all three interventions in random order. The study foods will be added to the participants' usual diet.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832071
Sponsor's protocol ID
UNL-00025516
Other IDs
2025-67017-44770, 2025
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified gut bacteria sequencing data, along with limited participant information, will be uploaded to the National Center for Biotechnology Information Sequence Read Archive. De-identified health-relevant data will be will be uploaded to the UNL Data Repository.

Publications

  • Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

    PubMed 3899825

Questions about this trial

What is this clinical trial studying?

A study testing Whole grain sumac sorghum, Whole grain white sorghum and White rice in people with Dietary Intervention and Gut Microbiota, run by University of Nebraska Lincoln 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 15 inclusion and 10 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: opening soon, as of the sponsor's last update on 21 Sep 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?

Contact Edward C Deehan, PhD, RD (402-472-1862, edeehan2@unl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin resistance as estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). (time frame: From baseline to the end of treatment at 4 weeks.). 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 NCT07832071, 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 21 Sep 2026.

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