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Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women (PSS1)

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ClinicalTrials.gov Identifier: NCT01928966
Recruitment Status : Withdrawn (Advisor left the university and student moved to a clinical track)
First Posted : August 27, 2013
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Blood Pressure Other: Pumpkin Seeds

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
Study Start Date : August 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group I - Pumpkin Seeds
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.
Other: Pumpkin Seeds
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).
Active Comparator: Group II - Pumpkin Seeds
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.
Other: Pumpkin Seeds
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).


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928966


Locations
United States, Texas
Texas Woman's University
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Woman's University
Investigators
Study Chair: John D Radcliffe, PhD Texas Woman's University
More Information

Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT01928966     History of Changes
Other Study ID Numbers: TWU-1PS
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study was stopped before data collection began - no data to share.

Keywords provided by Texas Woman's University:
dietary fat
fat intake
blood pressure
women
phytoestrogen
pumpkin seeds
cardiovascular disease
heart disease
secoisolariciresinol
monounsaturated fat
polyunsaturated fat
feeding study

Additional relevant MeSH terms:
Cardiovascular Diseases