[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656800":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":70,"studyPopulation":67,"armGroups":71,"interventions":100,"overallOfficials":113,"centralContacts":117,"locations":122,"responsibleParty":139,"collaborators":67,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":67,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":67,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":166,"whyStopped":67,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"University of Nebraska Lincoln","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Insulin resistance as estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).","Changes in circulating levels of glucose (Unit: mg\u002FdL) and insulin (Unit: uIU\u002FmL) 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.",[14,17,21,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Beta cell function as estimated by the Homeostatic Model Assessment for beta-cell function (HOMA-%B).","Changes in circulating levels of glucose (Unit: mg\u002FdL) and C-peptide (Unit: ng\u002FmL) 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.",{"measure":18,"description":19,"timeFrame":20},"Interstitial glucose dynamics by continuous glucose monitoring","Interstitial glucose dynamics (Unit: mg\u002FdL) when assessed continuously over a 10 day period.","Continuously over a 10 day period during the treatment weeks.",{"measure":22,"description":23,"timeFrame":12},"Lipid metabolism assessed by a lipid panel","Changes in circulating levels of total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides (Units: mg\u002FdL) when collected after fasting.",{"measure":25,"description":26,"timeFrame":12},"Systematic inflammation assessed by C-reactive protein","Changes in circulating levels of C-reactive protein (Unit: mg\u002FL) when collected after fasting.",{"measure":28,"description":29,"timeFrame":12},"Systematic inflammation assessed by glycosylated acute-phase proteins (GlycA)","Changes in circulating levels of glycosylated acute-phase proteins (Unit: umol\u002FL) when collected after fasting.",{"measure":31,"description":32,"timeFrame":12},"Systematic inflammation assessed by interleukin-6","Changes in circulating levels of interleukin-6 (Unit: pg\u002FmL) when collected after fasting.",{"measure":34,"description":35,"timeFrame":12},"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.",{"measure":37,"description":38,"timeFrame":12},"Fecal short-chain fatty acids assessed by gas chromatography","Changes in fecal concentrations of short-chain fatty acids as determined by gas chromatography.",{"measure":40,"description":41,"timeFrame":12},"Fecal pH assessed by pH meter","Changes in fecal pH as determined by pH meter.",{"measure":43,"description":44,"timeFrame":12},"Fecal dry mass assessed by oven-drying","Changes in fecal dry mass as determined by oven-drying.",[46,49,53,56,60],{"measure":47,"description":48,"timeFrame":12},"Blood pressure","Changes in blood pressure (Units: (mmHg) as evaluated by an clinic blood pressure monitor.",{"measure":50,"description":51,"timeFrame":52},"Perceived Satiety","Changes in perceived satiety assessed using the Satiety Labeled Intensity Magnitude (SLIM) Questionnaire.","At baseline and during the treatment weeks 2 and 4.",{"measure":54,"description":55,"timeFrame":52},"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\u002Fday), 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\\]).",{"measure":57,"description":58,"timeFrame":59},"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.","At baseline and during the treatment weeks 3 and 4.",{"measure":61,"description":62,"timeFrame":59},"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.",{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":6,"observationalModel":67,"timePerspective":67,"maskingInfo":68},"RANDOMIZED","CROSSOVER","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\u002Fday 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.",null,{"masking":69,"maskingDescription":67,"whoMasked":67},"NONE","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.\n\nThis 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.\n\nThe 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\u002Fday of the study grain. Clinical, metabolic, and microbiome-related outcomes will be assessed through repeated biospecimen collection and questionnaires.",[72,80,84,88,92,96],{"label":73,"type":74,"description":75,"interventionNames":76},"Intervention Scheme 1","ACTIVE_COMPARATOR","Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.",[77,78,79],"Other: Whole grain sumac sorghum","Other: Whole grain white sorghum","Other: White rice",{"label":81,"type":74,"description":82,"interventionNames":83},"Intervention Scheme 2","Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.",[77,78,79],{"label":85,"type":74,"description":86,"interventionNames":87},"Intervention Scheme 3","Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.",[77,78,79],{"label":89,"type":74,"description":90,"interventionNames":91},"Intervention Scheme 4","Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.",[77,78,79],{"label":93,"type":74,"description":94,"interventionNames":95},"Intervention Scheme 5","Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.",[77,78,79],{"label":97,"type":74,"description":98,"interventionNames":99},"Intervention Scheme 6","Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.\n\nIntervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.",[77,78,79],[101,105,109],{"type":6,"name":102,"description":103,"armGroupLabels":104,"otherNames":67},"Whole grain sumac sorghum","Whole grain sumac sorghum consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g\u002Fday of whole grain (3 ounce servings).",[73,81,85,89,93,97],{"type":6,"name":106,"description":107,"armGroupLabels":108,"otherNames":67},"Whole grain white sorghum","Whole grain white sorghum consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g\u002Fday of whole grain (3 ounce servings).",[73,81,85,89,93,97],{"type":6,"name":110,"description":111,"armGroupLabels":112,"otherNames":67},"White rice","White rice consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g\u002Fday of refined grain (3 ounce servings).",[73,81,85,89,93,97],[114],{"name":115,"affiliation":5,"role":116},"Edward C Deehan, PhD, RD","PRINCIPAL_INVESTIGATOR",[118],{"name":115,"role":119,"phone":120,"phoneExt":67,"email":121},"CONTACT","402-472-1862","edeehan2@unl.edu",[123],{"facility":124,"status":67,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"Nebraska Food for Health Center","Lincoln","Nebraska","68588","United States","US",{"type":131,"coordinates":132},"Point",[133,134],-96.66696,40.8,{"lat":134,"lon":133},[137,138],{"name":115,"role":119,"phone":120,"phoneExt":67,"email":121},{"name":115,"role":116,"phone":67,"phoneExt":67,"email":67},{"type":140,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100656800","phenolic-dependent-and-independent-effects-of-whole-grain-sorghum-on-immunometabolism-100656800",false,"NCT07832071","Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism","Inclusion Criteria:\n\n1. Between the age of 19 and 64 years.\n2. Not currently pregnant or planning to become pregnant (females only).\n3. Stable body mass index above or equal to 26 kg\u002Fm² (rounded up) for the last month.\n4. Body fat above or equal to 36% (female) or 25% (male) (rounded up).\n5. No major diet changes in the last month.\n6. Ability to eat provided study foods each day and avoid eating sorghum except for the study foods.\n7. Ability to wear a continuous glucose monitor for 10 days.\n8. Ability to have blood drawn after \\~12 hours of fasting.\n9. Have a bowel movement at least every third day.\n10. Ability to collect and deliver your stool samples to the study site within 4 hours of collection.\n11. No known allergies or intolerance to sorghum or rice.\n12. No known allergies to wheat or soy (study foods may contain wheat or soy)\n13. Able to read and speak English.\n14. Requires no legally authorized representative (LAR).\n15. Not institutionalized (e.g., prison, psychological treatment center, etc.).\n\nExclusion Criteria:\n\n1. Has cardiac device or history of organ transplant.\n2. History of cancer within the last year (excludes skin cancer).\n3. History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines.\n4. Current use of tobacco.\n5. Excessing alcohol use (≥8 drinks \\[female\\] or ≥15 drinks \\[male\\] per week).\n6. Taken antibiotics in the last 2 months.\n7. Current long-term use of anti-diabetic, anti-inflammatory, or cholesterol-lowering medications.\n8. Medication regimen or dosage changed within the last 2 months.\n9. Use of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements within the last 3 weeks.\n10. Supplement regimen or dosage changed within the last 3 weeks",true,"ALL","19 Years","64 Years",{"count":152,"type":153},30,"ESTIMATED","INTERVENTIONAL",[156],"NA","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:\n\n* Are markers of immune and metabolic health affected differently by eating high- vs low-phenolic whole grain sorghum?\n* Does the gut microbiome respond differently to eating high- vs low-phenolic whole grain sorghum, and does this response explain the health effects?\n\nResearchers 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.\n\nParticipants will:\n\n* 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).\n* Complete questionnaires asking about demographic, diet, lifestyle, quality-of-life, health, and gut health information.\n* Have height, weight, waist circumference, body composition, and blood pressure measured.\n* Wear a continuous glucose monitor 3 times, each for 10 days.\n* Have six blood draws, one saliva sample collection, and provide six stool samples.\n* Maintain a study journal during the three intervention phases.",[159,160,161,162],"Dietary Intervention","Gut Microbiota","Insulin Sensitivity\u002FResistance","Obesity & Overweight",[164,165,160],"Nutritional Microbiology","Sorghum bicolor","NOT_YET_RECRUITING","2026-09-15",{"date":169,"type":170},"2026-09-21","ACTUAL",{"date":172,"type":153},"2026-10",{"date":174,"type":153},"2029-07",{"name":5,"class":6},1]