Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-64
SponsorUniversity of Nebraska Lincoln
About this trial
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
This trial accepts healthy volunteersQualifiers
Between the age of 19 and 64 years.
Not currently pregnant or planning to become pregnant (females only).
Stable body mass index above or equal to 26 kg/m² (rounded up) for the last month.
Body fat above or equal to 36% (female) or 25% (male) (rounded up).
Disqualifiers
Has cardiac device or history of organ transplant.
History of cancer within the last year (excludes skin cancer).
History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines.
Current use of tobacco.
Trial design
Design model
Crossover
Treatments tested in this trial
Whole grain sumac sorghum
Other interventionWhole 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
Other interventionWhole 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
Other interventionWhite rice consumed as cereal, breadsticks, and grain pouches for 4 weeks, at an amount of 84 g/day of refined grain (3 ounce servings).
Treatment groups
30 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Intervention Scheme 1Active comparator 3 interventions
Group B: Intervention Scheme 2Active comparator 3 interventions
Group C: Intervention Scheme 3Active comparator 3 interventions
Group D: Intervention Scheme 4Active comparator 3 interventions
Group E: Intervention Scheme 5Active comparator 3 interventions
Group F: Intervention Scheme 6Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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 4.3
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 4.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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