MenopauseNCT04692298
Effects of Pulse Consumption on Bone Health of Postmenopausal Women
A study testing pulses in people with Menopause, run by Oklahoma State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- pulses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 year without menstrual cycle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutritional Sciences Department, Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause
- Being tested
- pulses
- Keywords
- bone health, pulses, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsesOther
kidney beans, pinto beans, lentil, black-eyed pea and chickpea
| Study group | Role | What they receive |
|---|---|---|
| Pulse | Other | Participants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea Receives: Other: pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blood biomarkers and/or bone mineral density (BMD)
analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD
Measured: 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
Measured: change from baseline after 90 days
blood procollagen type 1 N-propeptide (P1NP)
analyzed by enzyme-linked immunoassay
Measured: change from baseline after 90 days
fecal bacteria
analyzed by 16sRNA sequencing
Measured: change from baseline after 90 days
fecal short chain fatty acid
analyzed by gas chromatography
Measured: change from baseline after 90 days
fecal immunoglobulin A
analyzed by enzyme-linked immunoassay
Measured: change from baseline after 90 days
plasma concentrations of fatty acid binding protein
analyzed by enzyme-linked immunoassay
Measured: change from baseline after 90 days
Secondary outcomes (8)
fasting blood glucose
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
blood glycosylated hemoglobin
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
blood insulin
analyzed using enzyme linked immunoassay
Measured: change from baseline after 90 days
blood C-peptide
analyzed using enzyme linked immunoassay
Measured: change from baseline after 90 days
blood total cholesterol
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
blood HDL cholesterol
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
blood LDL cholesterol
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
blood triglycerides
analyzed using clinical chemistry analyzer
Measured: change from baseline after 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start22 Feb 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Edralin Lucas, Oklahoma State University
- Investigators
- EDRALIN A LUCAS, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692298
- Sponsor's protocol ID
- IRB-20-430
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04692298
- Acronym / sponsor ID
- IRB-20-430
- Conditions
- Menopause
- Keywords
- bone health, pulses, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse | Other | Other: pulsesParticipants will consume kidney beans, lentil, pinto beans, black-eyed pea, chickpea |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 year without menstrual cycle
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulseskidney beans, pinto beans, lentil, black-eyed pea and chickpea | Other | Pulse |
Primary outcome
changes in blood biomarkers and/or bone mineral density (BMD)
Time frame: change from baseline, after 90 days and 9 months (for BMD)
analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD
blood C-terminal telopeptide of type 1 collagen (CTX)
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
blood procollagen type 1 N-propeptide (P1NP)
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
fecal bacteria
Time frame: change from baseline after 90 days
analyzed by 16sRNA sequencing
fecal short chain fatty acid
Time frame: change from baseline after 90 days
analyzed by gas chromatography
fecal immunoglobulin A
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
plasma concentrations of fatty acid binding protein
Time frame: change from baseline after 90 days
analyzed by enzyme-linked immunoassay
8 secondary outcomes
fasting blood glucose
Time frame: change from baseline after 90 days
blood glycosylated hemoglobin
Time frame: change from baseline after 90 days
blood insulin
Time frame: change from baseline after 90 days
blood C-peptide
Time frame: change from baseline after 90 days
blood total cholesterol
Time frame: change from baseline after 90 days
blood HDL cholesterol
Time frame: change from baseline after 90 days
blood LDL cholesterol
Time frame: change from baseline after 90 days
blood triglycerides
Time frame: change from baseline after 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EDRALIN A LUCAS, PhD principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulses in people with Menopause, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in blood biomarkers and/or bone mineral density (BMD) (time frame: change from baseline, after 90 days and 9 months (for BMD)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.