Nebraska Food for Health Center
Lincoln, Nebraska, 68588, United States
NCT Number: NCT06935435
Beans are well known for their health benefits. Many of these benefits relate to gut health, as many of the nutrients found in beans support beneficial microbes that live in the gut. However, beans have a lot of genetic diversity. This diversity has led to different bean market classes with different colors, sizes, and nutrient profiles. Differences between bean market classes may trigger different effects on gut microbes and health, but this is poorly understood. The goal of the pilot clinical trial is to make comparisons (1) between two different bean market classes (pink beans, great northern beans) and (2) between a bean mixture (pinto, kidney, black, pink, and great northern beans) and individual bean market classes. The study will assess whether bean market classes differ in their effects on gut microbes, blood pressure, metabolism, and gut symptoms in adults with and without obesity.
This study is active but is not currently recruiting participants.
Notify Me19 year–50 year
All sexes
Interventional
Not applicable
Lincoln, Nebraska, 68588, United States
Bean consumption delivers diverse dietary fibers (resistant starches, non-starch polysaccharides), proteins, polyphenols, and other compounds to the colon, where they serve as substrates for the microbial community (microbiota) that colonizes the gut of humans. However, dry beans exhibit high genetic diversity, corresponding with diverse pigments and nutrients across market classes. It remains poorly understood whether targeted effects on the gut microbiota and health measures are possible with distinct dry bean market classes. The overarching study objective is to perform a randomized, crossover pilot intervention trial in adults to determine the effects of consuming distinct dry bean market classes in isolation or combination on the gut microbiota and health. The study will compare the dose-dependent effects of pink beans, great northern beans, and a five-bean mixture (pinto, kidney, black, pink, and great northern beans) on the gut microbiota, health-relevant metabolites, blood pressure, and immunometabolic markers in adults with and without extra body weight. The pilot study will employ a 3-phase, cross-over design with 2-week intervention periods separated by 2-week washout periods.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Time frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in bacterial composition, and precisely the relative abundance of Faecalibacterium, in fecal samples, as assessed by 16S rRNA gene amplicon sequencing.
Time frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in fecal concentrations of short-chain fatty acids as determined by gas chromatography.
Time frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale, where the scale is between 0 and 6 and higher values indicate more severe gastrointestinal symptoms.
Time frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent 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 three-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: From baseline to the end of treatment at 2 weeks.
Changes in 24-hour blood pressure as evaluated by an ambulatory blood pressure monitor.
Time frame: From baseline to the end of treatment at 2 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 2 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 2 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 2 weeks.
Changes in circulating levels of C-peptide (Unit: ng/mL) when collected after fasting.
Time frame: From baseline to the end of treatment at 2 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 2 weeks.
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.
University of Nebraska Lincoln
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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