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

Not Applicable

Withdrawn

• Conditions: Blood Pressure; Cardiovascular Disease
• Interventions: Other: Pumpkin Seeds

• Registration Number: NCT01928966
• Lead Sponsor: Texas Woman's University

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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group II - Pumpkin Seeds	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.
Group I - Pumpkin Seeds	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.

Primary Outcome Measures

Name	Time	Method
Dietary fatty acid intake	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	12 weeks	Blood pressure will be measured at every meeting to determine if the addition of pumpkin seeds to the diet altered blood pressure.

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Houston, Texas, United States