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

This study is currently recruiting participants.
Verified August 2013 by Texas Woman's University
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01928966
First received: August 21, 2013
Last updated: February 25, 2014
Last verified: August 2013
  Purpose

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 Intervention
Cardiovascular Disease
Blood Pressure
Other: Pumpkin Seeds

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women

Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • Dietary fatty acid intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood pressure will be measured at every meeting to determine if the addition of pumpkin seeds to the diet altered blood pressure.


Estimated Enrollment: 22
Study Start Date: August 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01928966

Contacts
Contact: Karen E Eldridge, BS 979-533-0674 k.elise07@gmail.com

Locations
United States, Texas
Texas Woman's University Recruiting
Houston, Texas, United States, 77030
Contact: Eldridge       k.elise07@gmail.com   
Principal Investigator: Karen E Eldridge, BS         
Sponsors and Collaborators
Texas Woman's University
Investigators
Study Chair: John D Radcliffe, PhD Texas Woman's University
  More Information

No publications provided

Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT01928966     History of Changes
Other Study ID Numbers: TWU-1PS
Study First Received: August 21, 2013
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014