Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| USDA Beltsville Human Nutrition Research Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse | Other | Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulses | Other | kidney beans, pinto beans, lentil, black-eyed pea and chickpea |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in blood biomarkers and/or bone mineral density (BMD) | analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD | change from baseline, after 90 days and 9 months (for BMD) |
| blood C-terminal telopeptide of type 1 collagen (CTX) | analyzed by enzyme-linked immunoassay | change from baseline after 90 days |
| blood procollagen type 1 N-propeptide (P1NP) | analyzed by enzyme-linked immunoassay | change from baseline after 90 days |
| fecal bacteria | analyzed by 16sRNA sequencing | change from baseline after 90 days |
| fecal short chain fatty acid | analyzed by gas chromatography | change from baseline after 90 days |
| fecal immunoglobulin A | analyzed by enzyme-linked immunoassay | change from baseline after 90 days |
| plasma concentrations of fatty acid binding protein | analyzed by enzyme-linked immunoassay | change from baseline after 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose | analyzed using clinical chemistry analyzer | change from baseline after 90 days |
| blood glycosylated hemoglobin | analyzed using clinical chemistry analyzer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| EDRALIN A LUCAS, PhD | Oklahoma State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutritional Sciences Department, Oklahoma State University | Stillwater | Oklahoma | 74078 | United States |
Not provided
| ID | Term |
|---|---|
| D011674 | Pulse |
| ID | Term |
|---|---|
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| change from baseline after 90 days |
| blood insulin | analyzed using enzyme linked immunoassay | change from baseline after 90 days |
| blood C-peptide | analyzed using enzyme linked immunoassay | change from baseline after 90 days |
| blood total cholesterol | analyzed using clinical chemistry analyzer | change from baseline after 90 days |
| blood HDL cholesterol | analyzed using clinical chemistry analyzer | change from baseline after 90 days |
| blood LDL cholesterol | analyzed using clinical chemistry analyzer | change from baseline after 90 days |
| blood triglycerides | analyzed using clinical chemistry analyzer | change from baseline after 90 days |