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Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 64 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 2 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Consume three study foods daily during three intervention phases, with each phase lasting four weeks."
  • "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."
  • "Clinical, metabolic, and microbiome-related outcomes will be assessed through repeated biospecimen collection and questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how whole grain sorghum affects immune health, how the body uses food, and gut microbes in adults with excess body weight. It compares sorghum with high or low levels of phenolics (plant compounds) to white rice. Participants eat study foods daily during three 4-week periods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 19–64; not pregnant or planning to become pregnant.
  • Stable body mass index (BMI, a measure based on height and weight) of at least 26 for the past month. Body fat must be at least 36% for women or 25% for men. These numbers may be rounded up.
  • No major diet changes in the past month. Able to eat study foods daily and avoid other sorghum foods.
  • No allergy or intolerance to sorghum or rice, and no allergy to wheat or soy.
  • Able to wear a blood sugar monitor for 10 days and have blood drawn after about 12 hours without food.
  • Have a bowel movement at least every third day. Able to collect stool samples and bring them to the study site within 4 hours.
  • Able to read and speak English and give consent without a legal representative.
  • Not living in an institution, such as a prison or mental health treatment center.

Who can't join

  • Have a heart device or have had an organ transplant.
  • Have had cancer within the past year, other than skin cancer.
  • Have had surgery or a doctor-diagnosed disease involving the stomach or intestines.
  • Currently use tobacco, or drink at least 8 alcoholic drinks per week for women or 15 for men.
  • Have taken antibiotics in the past 2 months.
  • Currently use medicines long-term for diabetes, inflammation, or lowering cholesterol.
  • Have changed medicines or medicine doses within the past 2 months.
  • Have used digestive enzymes, laxatives, fiber supplements, prebiotics, or probiotics (supplements that feed or add gut bacteria) within the past 3 weeks, or changed any supplements or doses during that time.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NE