Cardiovascular DiseasePSS1NCT01928966
Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
A study testing Pumpkin Seeds in people with Cardiovascular Disease and Blood Pressure, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Blood Pressure
- What is being tested?
- Pumpkin Seeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2014
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Over the age of 18
- Able to read, write, and speak English
- Able to keep a three-day diet diary
- Willing and able to consume pumpkin seeds
Who cannot join
- Pregnant or planning to become pregnant
- Allergic to pumpkin seeds
- High blood pressure
- Regularly consuming pumpkin seeds (more than 4 times per month)
- Taking blood pressure medication
- Liver disease
Show all 16Show fewer
- Kidney disease
- Gastrointestinal disease
- History of bariatric surgery
- History of a major cardiovascular event
- Heart disease
- Currently undergoing cancer treatment (except nonmelanoma cancer)
- Following a weight control diet
- Following a disease specific diet
- Following a vegan diet
- Have a diagnosed eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.
Read the detailed description
Cardiovascular disease is the number one cause of morbidity and mortality in United States. Diets high in polyunsaturated and monounsaturated fatty acids have been shown to decrease the risk of cardiovascular disease. Pumpkin seeds are a good source of monounsaturated and polyunsaturated fatty acids. Oil extracted from pumpkin seeds has been shown to lower blood pressure. One purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds per day will improve polyunsaturated and monounsaturated fatty acid intake in the diet in healthy adult women. Another purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds a day will lower blood pressure.
- Conditions
- Cardiovascular Disease, Blood Pressure
- Being tested
- Pumpkin Seeds
- Keywords
- dietary fat, fat intake, blood pressure, women, phytoestrogen, pumpkin seeds, cardiovascular disease, heart disease, secoisolariciresinol, monounsaturated fat, polyunsaturated fat, feeding study
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin SeedsOther
Participants will be asked to consume 1.5 ounces of raw, unsalted pumpkin seeds per day. The 1.5 ounces will be split in to two servings (each 0.75 ounces).
| Study group | Role | What they receive |
|---|---|---|
| Group I - Pumpkin Seeds | Active comparator | First four weeks of study: consume perceived normal diet; Second four weeks of study: receive 1.5 ounces of pumpkin seeds per day for consumption; Third four weeks of the study: consume their perceived normal diet. Receives: Other: Pumpkin Seeds |
| Group II - Pumpkin Seeds | Active comparator | First four weeks of study: consume perceived normal diet; Second four week period: consume perceived normal diet; Third four week period: receive 1.5 ounces of pumpkin seeds per day for consumption. Receives: Other: Pumpkin Seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary fatty acid intake
The dietary fatty acid intake, specifically monounsaturated and polyunsaturated fatty acids, will be measured three times over the course of a twelve week period to determine if fatty acid intake changed during the intervention.
Measured: 12 weeks
Blood pressure
Blood pressure will be measured at every meeting to determine if the addition of pumpkin seeds to the diet altered blood pressure.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Advisor left the university and student moved to a clinical track
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John D Radcliffe, PhD, Study chair, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928966
- Sponsor's protocol ID
- TWU-1PS
- Acronym
- PSS1
- Status last verified
- May 2017
- First submitted
- 21 Aug 2013
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The study was stopped before data collection began - no data to share.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
- ClinicalTrials.gov ID
- NCT01928966
- Acronym / sponsor ID
- PSS1 / TWU-1PS
- Conditions
- Cardiovascular Disease, Blood Pressure
- Keywords
- dietary fat, fat intake, blood pressure, women, phytoestrogen, pumpkin seeds, cardiovascular disease, heart disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Advisor left the university and student moved to a clinical track
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Aug 2013 (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 study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.
Detailed description
Cardiovascular disease is the number one cause of morbidity and mortality in United States. Diets high in polyunsaturated and monounsaturated fatty acids have been shown to decrease the risk of cardiovascular disease. Pumpkin seeds are a good source of monounsaturated and polyunsaturated fatty acids. Oil extracted from pumpkin seeds has been shown to lower blood pressure. One purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds per day will improve polyunsaturated and monounsaturated fatty acid intake in the diet in healthy adult women. Another purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds a day will lower blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Pumpkin Seeds | Active comparator | Other: Pumpkin SeedsFirst four weeks of study: consume perceived normal diet; Second four weeks of study: receive 1.5 ounces of pumpkin seeds per day for consumption; Third four weeks of the study: consume their perceived normal diet. |
| Group II - Pumpkin Seeds | Active comparator | Other: Pumpkin SeedsFirst four weeks of study: consume perceived normal diet; Second four week period: consume perceived normal diet; Third four week period: receive 1.5 ounces of pumpkin seeds per day for consumption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Over the age of 18
- Able to read, write, and speak English
- Able to keep a three-day diet diary
- Willing and able to consume pumpkin seeds
Key exclusion criteria (16 listed)
- Pregnant or planning to become pregnant
- Allergic to pumpkin seeds
- High blood pressure
- Regularly consuming pumpkin seeds (more than 4 times per month)
- Taking blood pressure medication
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 SeedsParticipants will be asked to consume 1.5 ounces of raw, unsalted pumpkin seeds per day. The 1.5 ounces will be split in to two servings (each 0.75 ounces). | Other | Group I - Pumpkin Seeds, Group II - Pumpkin Seeds |
Primary outcome
Dietary fatty acid intake
Time frame: 12 weeks
The dietary fatty acid intake, specifically monounsaturated and polyunsaturated fatty acids, will be measured three times over the course of a twelve week period to determine if fatty acid intake changed during the intervention.
Blood pressure
Time frame: 12 weeks
Blood pressure will be measured at every meeting to determine if the addition of pumpkin seeds to the diet altered blood pressure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No. The study was stopped before data collection began - no data to share.
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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.
John D Radcliffe, 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 Seeds in people with Cardiovascular Disease and Blood Pressure, 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 30 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dietary fatty acid intake (time frame: 12 weeks). The study lists 2 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 30 May 2017.