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NCT07832071
Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism
Conditions: Dietary Intervention, Gut Microbiota, Insulin Sensitivity/Resistance, Obesity & Overweight
Sex: All
Ages: 19 Years – 64 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: University of Nebraska Lincoln
Location: Nebraska Food for Health Center Lincoln Nebraska
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.
Eligibility Criteria
Inclusion Criteria:
1. Between the age of 19 and 64 years.
2. Not currently pregnant or planning to become pregnant (females only).
3. Stable body mass index above or equal to 26 kg/m² (rounded up) for the last month.
4. Body fat above or equal to 36% (female) or 25% (male) (rounded up).
5. No major diet changes in the last month.
6. Ability to eat provided study foods each day and avoid eating sorghum except for the study foods.
7. Ability to wear a continuous glucose monitor for 10 days.
8. Ability to have blood drawn after \~12 hours of fasting.
9. Have a bowel movement at least every third day.
10. Ability to collect and deliver your stool samples to the study site within 4 hours of collection.
11. No known allergies or intolerance to sorghum or rice.
12. No known allergies to wheat or soy (study foods may contain wheat or soy)
13. Able to read and speak English.
14. Requires no legally authorized representative (LAR).
15. Not institutionalized (e.g., prison, psychological treatment center, etc.).
Exclusion Criteria:
1. Has cardiac device or history of organ transplant.
2. History of cancer within the last year (excludes skin cancer).
3. History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines.
4. Current use of tobacco.
5. Excessing alcohol use (≥8 drinks \[female\] or ≥15 drinks \[male\] per week).
6. Taken antibiotics in the last 2 months.
7. Current long-term use of anti-diabetic, anti-inflammatory, or cholesterol-lowering medications.
8. Medication regimen or dosage changed within the last 2 months.
9. Use of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements within the last 3 weeks.
10. Supplement regimen or dosage changed within the last 3 weeks
Source: ClinicalTrials.gov (NCT07832071). StuddyBuddy aggregates publicly available trial information.