Nebraska Food for Health Center
Lincoln, Nebraska, 68588, United States
Location contact
Edward C Deehan, PhD, RD
CONTACT
Edward C Deehan, PhD, RD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07832071
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.
Trial opening soon.
Get Notified19 year–64 year
All sexes
Interventional
Not applicable
Lincoln, Nebraska, 68588, United States
Edward C Deehan, PhD, RD
CONTACT
Edward C Deehan, PhD, RD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: From baseline to the end of treatment at 4 weeks.
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.
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: Continuously over a 10 day period during the treatment weeks.
Interstitial glucose dynamics (Unit: mg/dL) when assessed continuously over a 10 day period.
Time frame: From baseline to the end of treatment at 4 weeks.
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.
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.
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.
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.
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.
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.
Changes in fecal pH as determined by pH meter.
Time frame: From baseline to the end of treatment at 4 weeks.
Changes in fecal dry mass as determined by oven-drying.
Time frame: From baseline to the end of treatment at 4 weeks.
Changes in blood pressure (Units: (mmHg) as evaluated by an clinic blood pressure monitor.
Time frame: At baseline and during the treatment weeks 2 and 4.
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.
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 3 and 4.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Nebraska Lincoln
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