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N/A

Dietary Pulses for Postmenopausal Bone Health

N/A
Recruiting
Led By EDRALIN A LUCAS, PhD
Research Sponsored by Oklahoma State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

Study Summary

This trial will study how adding 100g of cooked pulses to a postmenopausal woman's diet for 12 weeks affects gut health, metabolism, and bone markers.

Who is the study for?
This trial is for postmenopausal women who haven't had a menstrual cycle in at least one year. Participants should not use tobacco, have allergies to pulses, or have had major surgery within the last six months. They also shouldn't consume excessive alcohol or be on medications that affect glucose, lipids, bone health, inflammation markers, dietary supplements or non-steroidal anti-inflammatory drugs.Check my eligibility
What is being tested?
The study examines how adding 100 grams/day of cooked pulses (like lentils and chickpeas) to the diet affects gut health, metabolism and bone markers in postmenopausal women over a period of 12 weeks.See study design
What are the potential side effects?
While specific side effects are not listed for consuming pulses as part of this trial's intervention, potential general side effects may include gastrointestinal discomfort such as bloating or gas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
fecal bacteria
fecal immunoglobulin A
fecal short chain fatty acid
+1 more
Secondary outcome measures
blood C-peptide
blood C-terminal telopeptide of type 1 collagen (CTX)
blood HDL cholesterol
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PulseExperimental Treatment1 Intervention
Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea

Find a Location

Who is running the clinical trial?

Oklahoma State UniversityLead Sponsor
46 Previous Clinical Trials
8,231 Total Patients Enrolled
USDA Beltsville Human Nutrition Research CenterFED
54 Previous Clinical Trials
5,240 Total Patients Enrolled
EDRALIN A LUCAS, PhDPrincipal InvestigatorOklahoma State University

Media Library

Pulses (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04692298 — N/A
Menopause Research Study Groups: Pulse
Menopause Clinical Trial 2023: Pulses Highlights & Side Effects. Trial Name: NCT04692298 — N/A
Pulses (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific eligibility requirements for participation in this clinical trial?

"The research team seeks 40 female participants aged between 45 and 65 who have gone through menopause, evidenced by having sustained an absence of menstruation for one year."

Answered by AI

Are recruitment efforts for this experiment ongoing?

"According to the information accessible through clinicaltrials.gov, this research endeavour is currently seeking participants, having been initially posted on February 22nd 2021 and most recently updated April 19th 2022."

Answered by AI

What effects are researchers expecting from the results of this trial?

"During the 90 day trial period, researchers will measure fecal immunoglobulin A levels as a primary outcome. Secondary outcomes such as LDL cholesterol and triglycerides will be evaluated via clinical chemistry analyzer while bone density is assessed by dual energy xray absorptiometry."

Answered by AI

How many individuals are currently receiving treatment in this trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is recruiting patients from one facility and the information was last updated on April 19th 2022. The study began enlisting participants in February of 2021 and requires 40 people in total."

Answered by AI

Does this research investigation accept subjects aged over fifty-five?

"This medical trial has an age eligibility range of 45 to 65 years old."

Answered by AI
~10 spots leftby Mar 2025