Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women
| Registry | NCT04692298 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 41 (Actual) |
| Sponsor | Oklahoma State University (Other); collaborators: USDA Beltsville Human Nutrition Research Center |
| Conditions | Menopause |
| Interventions | pulses (Other) |
| Dates | start 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 in United States |
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All trials for Menopause All trials of pulses
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pulse | Other | Other: pulses | Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea |
Sex: Female, ages: 45 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * 1 year without menstrual cycle Exclusion Criteria: * any medication use (for the past 6 m) that affects glucose, lipids, bone and inflammation markers, dietary supplements, and non-steroidal anti-inflammatory medications * allergy to pulse crops * tobacco use * excessive alcohol intake * antibiotic use * major surgery within 6 m of study enrollment
| Facility | City | Country | Status |
|---|---|---|---|
| Nutritional Sciences Department, Oklahoma State University | Stillwater, Oklahoma | United States |