Nutritional Sciences Department, Oklahoma State University
Stillwater, Oklahoma, 74078, United States
NCT Number: NCT04692298
This study will investigate the effects of the addition of 100 grams/day of cooked pulses (i.e. lentil, pinto beans, peas, chickpeas, kidney beans) to the diet of postmenopausal women for 12 weeks on gut health, metabolic outcomes and bone biomarkers.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
Stillwater, Oklahoma, 74078, United States
With approximately 1.3 million women reaching menopause each year in the US and about one-third of a woman's life is spent in this state, it is imperative to identify effective, safe, and economical approaches that can minimize disease risk that is associated with this phase of life. Pulses are excellent source of fiber, protein, essential amino acids, vitamins, minerals and phytochemicals, that can act as prebiotics and prevent gut dysbiosis and promote a healthy gut. A few studies in overweight or obese adults have shown the health benefits of pulses, including gut modulating potential. However, studies examining the use of pulse crops are limited, especially in alleviating health risks associated with menopause. The objective of this study is to evaluate the prebiotic potential of pulse-based diet and consequent effects on metabolic and bone biomarkers in postmenopausal women. We hypothesize that daily intake of pulses, due to its nutrient content and many other bioactive compounds including fiber content, will beneficially affect gut health and subsequently improve metabolic outcomes and bone markers in postmenopausal women. To accomplish our objectives, 40 postmenopausal women (50- 65 y old and ≥ 1 y menopause) will be recruited and will be asked to consume 100 g/d of pulse (alternate between lentils, pinto beans, peas, chickpeas, and kidney beans) for 3 months. Pulse intake, anthropometric measures, markers of gut and bone health, and metabolic outcomes will be assessed at baseline and at the end of pulse consumption.
Once the study was underway and we got more funding, women were given the option to continue pulse supplementation for another six months to examine changes on bone density.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
kidney beans, pinto beans, lentil, black-eyed pea and chickpea
Time frame: change from baseline, after 90 days and 9 months (for BMD)
analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
Time frame: change from baseline after 90 days
analyzed by 16sRNA sequencing
Time frame: change from baseline after 90 days
analyzed by gas chromatography
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Time frame: change from baseline after 90 days
analyzed using enzyme linked immunoassay
Time frame: change from baseline after 90 days
analyzed using enzyme linked immunoassay
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Time frame: change from baseline after 90 days
analyzed using clinical chemistry analyzer
Oklahoma State University
Other
Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women
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