Clinical trial NCT04692298: Effects of Pulse Consumption on Bone Health of Postmenopausal Women
Official title: Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: bone health
pulses
microbiome
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2020-12-31
Enrollment: 41
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in blood biomarkers and/or bone mineral density (BMD)
timeFrame: change from baseline, after 90 days and 9 months (for BMD)
measure: blood C-terminal telopeptide of type 1 collagen (CTX)
timeFrame: change from baseline after 90 days
measure: blood procollagen type 1 N-propeptide (P1NP)
timeFrame: change from baseline after 90 days
measure: fecal bacteria
timeFrame: change from baseline after 90 days
measure: fecal short chain fatty acid
timeFrame: change from baseline after 90 days
measure: fecal immunoglobulin A
timeFrame: change from baseline after 90 days
measure: plasma concentrations of fatty acid binding protein
timeFrame: change from baseline after 90 days
Secondary outcomes:
measure: fasting blood glucose
timeFrame: change from baseline after 90 days
measure: blood glycosylated hemoglobin
timeFrame: change from baseline after 90 days
measure: blood insulin
timeFrame: change from baseline after 90 days
measure: blood C-peptide
timeFrame: change from baseline after 90 days
measure: blood total cholesterol
timeFrame: change from baseline after 90 days
measure: blood HDL cholesterol
timeFrame: change from baseline after 90 days
measure: blood LDL cholesterol
timeFrame: change from baseline after 90 days
measure: blood triglycerides
timeFrame: change from baseline after 90 days
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Nutritional Sciences Department, Oklahoma State University
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: EDRALIN A LUCAS, PhD
role: PRINCIPAL_INVESTIGATOR
References: