An interventional study of Whole grain sumac sorghum and Whole grain white sorghum in Dietary Intervention, Gut Microbiota and Insulin Sensitivity/Resistance, sponsored by University of Nebraska Lincoln. Not yet recruiting at 1 site in United States. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Nebraska Lincoln · Not applicable, Interventional, and Other
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:
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:
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.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Nebraska Lincoln is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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 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 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 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
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 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 consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g/day of refined grain (3 ounce servings).
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.
Time frame: From baseline to the end of treatment at 4 weeks.
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Interstitial glucose dynamics by continuous glucose monitoring
Interstitial glucose dynamics (Unit: mg/dL) when assessed continuously over a 10 day period.
Time frame: Continuously over a 10 day period during the treatment weeks.
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Systematic inflammation assessed by C-reactive protein
Changes in circulating levels of C-reactive protein (Unit: mg/L) when collected after fasting.
Time frame: From baseline to the end of treatment at 4 weeks.
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Systematic inflammation assessed by interleukin-6
Changes in circulating levels of interleukin-6 (Unit: pg/mL) when collected after fasting.
Time frame: From baseline to the end of treatment at 4 weeks.
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Fecal short-chain fatty acids assessed by gas chromatography
Changes in fecal concentrations of short-chain fatty acids as determined by gas chromatography.
Time frame: From baseline to the end of treatment at 4 weeks.
Fecal pH assessed by pH meter
Changes in fecal pH as determined by pH meter.
Time frame: From baseline to the end of treatment at 4 weeks.
Fecal dry mass assessed by oven-drying
Changes in fecal dry mass as determined by oven-drying.
Time frame: From baseline to the end of treatment at 4 weeks.
Blood pressure
Changes in blood pressure (Units: (mmHg) as evaluated by an clinic blood pressure monitor.
Time frame: From baseline to the end of treatment at 4 weeks.
Perceived Satiety
Changes in perceived satiety assessed using the Satiety Labeled Intensity Magnitude (SLIM) Questionnaire.
Time frame: At baseline and during the treatment weeks 2 and 4.
Bowel movement habits assessed by a Bowel Habits Questionnaire
Changes in bowel movement (BM) habits as assessed using a Bowel Habits Questionnaire, which has been previously described by Deehan and colleagues. The questionnaire asks participants to record and describe their BMs over four-days to obtain information on BM frequency (number of BM/day), stool consistency (Bristol Stool Scale, 1 \[hard\] to 7 \[liquid\]), perceived stool hardness (1 \[soft\] to 4 \[very hard\]), straining during bowel movement, discomfort during bowel movement, sensation of incomplete evacuation (1 \[none\] to 4 \[severe\]).
Time frame: At baseline and during the treatment weeks 2 and 4.
Gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale
Changes in gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale, where the scale is between 1 and 7 and higher values indicate more severe gastrointestinal symptoms.
Time frame: At baseline and during the treatment weeks 3 and 4.
Percent body fat assessed by bioelectrical impedance analysis
Changes in percent body fat assessed by an InBody 770 bioelectrical impedance analyzer. The validity of the InBody 770 bioelectrical impedance analyzer has been previously described by Brewer and colleagues.
Time frame: At baseline and during the treatment weeks 3 and 4.
Plan to share: 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.
Supporting information: Informed consent form
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.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 23 months is close to that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Nebraska Lincoln