HypertensionNCT02727036
Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women
A study testing Pumpkin seed oil and Pumpkin seeds in people with Hypertension and Dyslipidemia, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP)… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Pumpkin seed oil and Pumpkin seeds
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 10 Nov 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non-hypertensive with blood pressure less than140/90 mmHg
- Post menopausal women or had a bilateral oophorectomy
Who cannot join
- Hypotensive women with BP <90/60
- Taking medications to manage blood pressure and blood lipids
- Taking estrogen supplements or on hormone replacement therapy
- Taking pumpkin seed oil supplements
- Consuming pumpkin seeds more than ¼ cup a month
- Diagnosed with depression and taking antidepressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women
The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in postmenopausal women.
Read the detailed description
At the onset of menopause CVD rates increase in women. A beneficial effect of pumpkin seed oil on blood pressure has been observed in postmenopausal women. More than 1 in 3 female adults have some form of cardiovascular disease (CVD), which is affected by blood pressure.
Pumpkin seed is a good source of phytoestrogens. Phytoestrogens are compounds found in plants and are comparable to human estrogen, capable of producing estrogenic effects. Studies in post menopausal women have demonstrated that pumpkin seed oil, at a dose of 2g per day for 12 weeks can decrease blood pressure and reduce menopausal symptoms.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Pumpkin seed oil, Pumpkin seeds
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin seed oilDietary supplement
1 gram capsule of Pumpkin seed oil.
Pumpkin seedsDietary supplement
4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds
| Study group | Role | What they receive |
|---|---|---|
| Pumpkin seed oil | Experimental | Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks Receives: Dietary Supplement: Pumpkin seed oil |
| Pumpkin seeds | Active comparator | Packet of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks Receives: Dietary Supplement: Pumpkin seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Measured: change measured - baseline and 12 weeks
Secondary outcomes (6)
Change in Total Cholesterol level (mg/dl)
Measured: change measured - baseline and 12 weeks
Change in Plasma Triglycerides (mg/dl)
Measured: change measured - baseline and 12 weeks
Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)
High-density Lipoprotein-C
Measured: change measured - baseline and 12 weeks
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
Measured: change measured - baseline and 12 weeks
Change in C-reactive protein (CRP)
Measured: change measured - baseline and 12 weeks
Change in Endothelial Function
Endothelial function will be assessed using a computer based non-invasive peripheral arterial tonometer (Endo-PAT 2000, Itamar Medical Ltd.).
Measured: change measured - baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start1 Aug 2015
- Primary completion16 Jun 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madhura Maiya, MS, Principal investigator, Texas Woman's UniversityCarolyn Moore, PhD, Study chair, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727036
- Sponsor's protocol ID
- 17696
- Status last verified
- May 2018
- First submitted
- 21 Mar 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gossell-Williams M, Lyttle K, Clarke T, Gardner M, Simon O. Supplementation with pumpkin seed oil improves plasma lipid profile and cardiovascular outcomes of female non-ovariectomized and ovariectomized Sprague-Dawley rats. Phytother Res. 2008 Jul;22(7):873-7. doi: 10.1002/ptr.2381.
PubMed 18567058Gossell-Williams M, Hyde C, Hunter T, Simms-Stewart D, Fletcher H, McGrowder D, Walters CA. Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study. Climacteric. 2011 Oct;14(5):558-64. doi: 10.3109/13697137.2011.563882. Epub 2011 May 5.
PubMed 21545273
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02727036
- Acronym / sponsor ID
- 17696
- Conditions
- Hypertension, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- 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.
The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in postmenopausal women.
Detailed description
At the onset of menopause CVD rates increase in women. A beneficial effect of pumpkin seed oil on blood pressure has been observed in postmenopausal women. More than 1 in 3 female adults have some form of cardiovascular disease (CVD), which is affected by blood pressure.
Pumpkin seed is a good source of phytoestrogens. Phytoestrogens are compounds found in plants and are comparable to human estrogen, capable of producing estrogenic effects. Studies in post menopausal women have demonstrated that pumpkin seed oil, at a dose of 2g per day for 12 weeks can decrease blood pressure and reduce menopausal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumpkin seed oil | Experimental | Dietary Supplement: Pumpkin seed oilPumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks |
| Pumpkin seeds | Active comparator | Dietary Supplement: Pumpkin seedsPacket of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Non-hypertensive with blood pressure less than140/90 mmHg
- Post menopausal women or had a bilateral oophorectomy
Key exclusion criteria (6 listed)
- Hypotensive women with BP <90/60
- Taking medications to manage blood pressure and blood lipids
- Taking estrogen supplements or on hormone replacement therapy
- Taking pumpkin seed oil supplements
- Consuming pumpkin seeds more than ¼ cup a month
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 |
|---|---|---|
| Pumpkin seed oil1 gram capsule of Pumpkin seed oil. | Dietary supplement | Pumpkin seed oil |
| Pumpkin seeds4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds | Dietary supplement | Pumpkin seeds |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: change measured - baseline and 12 weeks
6 secondary outcomes
Change in Total Cholesterol level (mg/dl)
Time frame: change measured - baseline and 12 weeks
Change in Plasma Triglycerides (mg/dl)
Time frame: change measured - baseline and 12 weeks
Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)
Time frame: change measured - baseline and 12 weeks
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
Time frame: change measured - baseline and 12 weeks
Change in C-reactive protein (CRP)
Time frame: change measured - baseline and 12 weeks
Change in Endothelial Function
Time frame: change measured - baseline and 12 weeks
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 May 2018.
- Results publication: PubMed 18567058Gossell-Williams M, Lyttle K, Clarke T, Gardner M, Simon O. Supplementation with pumpkin seed oil improves plasma lipid profile and cardiovascular outcomes of female non-ovariectomized and ovariectomized Sprague-Dawley rats. Phytother Res. 2008 Jul;22(7):873-7. doi: 10.1002/ptr.2381.
- Results publication: PubMed 21545273Gossell-Williams M, Hyde C, Hunter T, Simms-Stewart D, Fletcher H, McGrowder D, Walters CA. Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study. Climacteric. 2011 Oct;14(5):558-64. doi: 10.3109/13697137.2011.563882. Epub 2011 May 5.
- Individual participant dataSharing planned: No
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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.
Madhura Maiya, MS principal investigator
Texas Woman's University
Carolyn Moore, PhD study chair
Texas Woman's 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 Pumpkin seed oil and Pumpkin seeds in people with Hypertension and Dyslipidemia, run by Texas Woman's 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 2 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 May 2018. 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?
Change in systolic and diastolic blood pressure (time frame: change measured - baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727036, which also lists 2 linked publications.
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 May 2018.