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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease; Blood Pressure
• Intervention / Treatment: 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Study Chair: John D Radcliffe, PhD, Texas Woman's University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cardiovascular disease; blood pressure; women; phytoestrogen; heart disease; dietary fat; fat intake; pumpkin seeds; secoisolariciresinol; monounsaturated fat; polyunsaturated fat; feeding study
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: TWU-1PS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study was stopped before data collection began - no data to share.