Clinical Trials Directory

Trials / Completed

CompletedNCT04692298

Effects of Pulse Consumption on Bone Health of Postmenopausal Women

Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
Oklahoma State University · Academic / Other
Sex
Female
Age
45 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERpulseskidney beans, pinto beans, lentil, black-eyed pea and chickpea

Timeline

Start date
2021-02-22
Primary completion
2023-12-30
Completion
2023-12-30
First posted
2020-12-31
Last updated
2024-04-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04692298. Inclusion in this directory is not an endorsement.