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

Sponsor

Texas Woman's University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01928966

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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	Phase
Cardiovascular Disease Blood Pressure	Other: Pumpkin Seeds	N/A

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

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 :

Aug 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 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).

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

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.