Effects of Pulse Consumption on Bone Health of Postmenopausal Women (NCT04692298) | Clinical Trial Compass
CompletedNot Applicable
Effects of Pulse Consumption on Bone Health of Postmenopausal Women
United States41 participantsStarted 2021-02-22
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
changes in blood biomarkers and/or bone mineral density (BMD)
Timeframe: change from baseline, after 90 days and 9 months (for BMD)
2
blood C-terminal telopeptide of type 1 collagen (CTX)
Timeframe: change from baseline after 90 days
3
blood procollagen type 1 N-propeptide (P1NP)
Timeframe: change from baseline after 90 days
4
fecal bacteria
Timeframe: change from baseline after 90 days
5
fecal short chain fatty acid
Timeframe: change from baseline after 90 days
6
fecal immunoglobulin A
Timeframe: change from baseline after 90 days
7
plasma concentrations of fatty acid binding protein