Effects of Pulse Consumption on Bone Health of Postmenopausal Women

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Other: pulses

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Nutritional Sciences Department, Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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
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
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)

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

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Collaborators: USDA Beltsville Human Nutrition Research Center
• Investigators: Principal Investigator: EDRALIN A LUCAS, PhD, Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: microbiome; bone health; pulses
• Other Study ID Numbers: IRB-20-430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No