Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism

NCT07832071 | Not Yet Recruiting

• 3 other identifiers: UNL-000255162025-67017-447702025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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? 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.

Conditions

Dietary Intervention; Gut Microbiota; Insulin Sensitivity/Resistance; Obesity & Overweight

Keywords

Nutritional Microbiology; Sorghum bicolor; Gut Microbiota

Outcome Measures

Primary Outcomes (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.

  From baseline to the end of treatment at 4 weeks.

Secondary Outcomes (10)

• Beta cell function as estimated by the Homeostatic Model Assessment for beta-cell function (HOMA-%B).

  From baseline to the end of treatment at 4 weeks.

• Interstitial glucose dynamics by continuous glucose monitoring

  Continuously over a 10 day period during the treatment weeks.

• Lipid metabolism assessed by a lipid panel

  From baseline to the end of treatment at 4 weeks.

• Systematic inflammation assessed by C-reactive protein

  From baseline to the end of treatment at 4 weeks.

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

  From baseline to the end of treatment at 4 weeks.

Other Outcomes (5)

• Blood pressure

  From baseline to the end of treatment at 4 weeks.

• Perceived Satiety

  At baseline and during the treatment weeks 2 and 4.

• Bowel movement habits assessed by a Bowel Habits Questionnaire

  At baseline and during the treatment weeks 2 and 4.

Study Arms (6)

Intervention Scheme 1

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Intervention Scheme 2

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Intervention Scheme 3

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Intervention Scheme 4

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Intervention Scheme 5

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Intervention Scheme 6

ACTIVE COMPARATOR

Intervention 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.

Other: Whole grain sumac sorghum; Other: Whole grain white sorghum; Other: White rice

Interventions

Whole grain sumac sorghum OTHER

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).

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

Whole grain white sorghum OTHER

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).

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

White rice OTHER

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).

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

Nebraska Food for Health Center

Lincoln, Nebraska, 68588, United States

Location

Related Publications (1)

• 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.

  PMID: 3899825 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward C Deehan, PhD, RD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward C Deehan, PhD, RD

CONTACT

402-472-1862; edeehan2@unl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The de-identified data will be made available upon publication of study findings.
• Access Criteria: Data will be available for download at the National Center for Biotechnology Information Sequence Read Archive and the UNL Data Repository.

Locations

US (1)