Menopause
Conditions
Keywords
bone health, pulses, microbiome
Brief 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.
Interventions
OTHERpulses
kidney beans, pinto beans, lentil, black-eyed pea and chickpea
Sponsors
USDA Beltsville Human Nutrition Research Center
Oklahoma State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in blood biomarkers and/or bone mineral density (BMD) | change from baseline, after 90 days and 9 months (for BMD) | analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD |
| blood C-terminal telopeptide of type 1 collagen (CTX) | change from baseline after 90 days | analyzed by enzyme-linked immunoassay |
| blood procollagen type 1 N-propeptide (P1NP) | change from baseline after 90 days | analyzed by enzyme-linked immunoassay |
| fecal bacteria | change from baseline after 90 days | analyzed by 16sRNA sequencing |
| fecal short chain fatty acid | change from baseline after 90 days | analyzed by gas chromatography |
| fecal immunoglobulin A | change from baseline after 90 days | analyzed by enzyme-linked immunoassay |
| plasma concentrations of fatty acid binding protein | change from baseline after 90 days | analyzed by enzyme-linked immunoassay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
| blood triglycerides | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
| blood glycosylated hemoglobin | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
| blood insulin | change from baseline after 90 days | analyzed using enzyme linked immunoassay |
| blood C-peptide | change from baseline after 90 days | analyzed using enzyme linked immunoassay |
| blood total cholesterol | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
| blood HDL cholesterol | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
| blood LDL cholesterol | change from baseline after 90 days | analyzed using clinical chemistry analyzer |
Countries
United States
Outcome results
None listed