Effects od Pulse Consumption on Bone Health of Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menopause

Intervention / Treatment
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* Other: pulses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pulse<br>Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea | Other: pulses<br>* kidney beans, pinto beans, lentil, black-eyed pea and chickpea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 
| 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 | 
| bone density | assessed by dual energy xray absorptiometry | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone health, pulses, microbiome