Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
University of Nebraska Lincoln
Study ID
NCT07832071
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - 64 Years
Healthy Volunteers
Accepted

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).
  • 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).
  • 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).

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Intervention Scheme 1
    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.
  • Active Comparator: Intervention Scheme 2
    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.
  • Active Comparator: Intervention Scheme 3
    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.
  • Active Comparator: Intervention Scheme 4
    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.
  • Active Comparator: Intervention Scheme 5
    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.
  • Active Comparator: Intervention Scheme 6
    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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nebraska Food for Health CenterLincolnNebraska68588
Edward C Deehan, PhD, RD
402-472-1862
Edward C Deehan, PhD, RD (PRINCIPAL_INVESTIGATOR)

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