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Dietary Pulses for Postmenopausal Bone Health
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Waitlist Available
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 change from baseline after 90 days
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline, after 90 days and 9 months (for bmd)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, after 90 days and 9 months (for bmd)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
blood C-terminal telopeptide of type 1 collagen (CTX)
blood procollagen type 1 N-propeptide (P1NP)
changes in blood biomarkers and/or bone mineral density (BMD)
+4 moreSecondary outcome measures
blood C-peptide
blood HDL cholesterol
blood LDL cholesterol
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PulseExperimental Treatment1 Intervention
Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea
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Who is running the clinical trial?
Oklahoma State UniversityLead Sponsor
46 Previous Clinical Trials
8,139 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke or use tobacco products.You have recently taken antibiotics.You are allergic to foods made from pulse crops.You drink too much alcohol.You have taken certain medications or supplements in the last 6 months that can affect your blood sugar, cholesterol, bone density, or inflammation levels.
Research Study Groups:
This trial has the following groups:- Group 1: Pulse
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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