NCT04692298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

December 16, 2020

Last Update Submit

April 1, 2024

Conditions

Menopause

Keywords

bone healthpulsesmicrobiome

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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

  • 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 Outcomes (8)

  • fasting blood glucose

    change from baseline after 90 days

  • blood glycosylated hemoglobin

    change from baseline after 90 days

  • blood insulin

    change from baseline after 90 days

  • blood C-peptide

    change from baseline after 90 days

  • blood total cholesterol

    change from baseline after 90 days

  • +3 more secondary outcomes

Study Arms (1)

Pulse

OTHER

Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea

Other: pulses

Interventions

pulsesOTHER

kidney beans, pinto beans, lentil, black-eyed pea and chickpea

Pulse

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year without menstrual cycle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutritional Sciences Department, Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Interventions

Pulse

Intervention Hierarchy (Ancestors)

HemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • EDRALIN A LUCAS, PhD

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jim an Lynn Williams Professor

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 31, 2020

Study Start

February 22, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations

US(1)