Effects of Pulse Consumption on Bone Health of Postmenopausal Women

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692298
• Other study ID #: IRB-20-430
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Other:
• pulses
kidney beans, pinto beans, lentil, black-eyed pea and chickpea

Locations

Country	Name	City	State
United States	Nutritional Sciences Department, Oklahoma State University	Stillwater	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	blood C-terminal telopeptide of type 1 collagen (CTX)	analyzed by enzyme-linked immunoassay	change from baseline after 90 days
Primary	blood procollagen type 1 N-propeptide (P1NP)	analyzed by enzyme-linked immunoassay	change from baseline after 90 days
Primary	fecal bacteria	analyzed by 16sRNA sequencing	change from baseline after 90 days
Primary	fecal short chain fatty acid	analyzed by gas chromatography	change from baseline after 90 days
Primary	fecal immunoglobulin A	analyzed by enzyme-linked immunoassay	change from baseline after 90 days
Primary	plasma concentrations of fatty acid binding protein	analyzed by enzyme-linked immunoassay	change from baseline after 90 days
Secondary	fasting blood glucose	analyzed using clinical chemistry analyzer	change from baseline after 90 days
Secondary	blood glycosylated hemoglobin	analyzed using clinical chemistry analyzer	change from baseline after 90 days
Secondary	blood insulin	analyzed using enzyme linked immunoassay	change from baseline after 90 days
Secondary	blood C-peptide	analyzed using enzyme linked immunoassay	change from baseline after 90 days
Secondary	blood total cholesterol	analyzed using clinical chemistry analyzer	change from baseline after 90 days
Secondary	blood HDL cholesterol	analyzed using clinical chemistry analyzer	change from baseline after 90 days
Secondary	blood LDL cholesterol	analyzed using clinical chemistry analyzer	change from baseline after 90 days
Secondary	blood triglycerides	analyzed using clinical chemistry analyzer	change from baseline after 90 days