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

NCT ID: NCT01928966

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-11-30

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.

Conditions

Cardiovascular Disease; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pumpkin Seeds

Intervention Type: OTHER

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).

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.

Group Type: ACTIVE_COMPARATOR

Pumpkin Seeds

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D Radcliffe, PhD

Role: STUDY_CHAIR

Texas Woman's University

Locations

Texas Woman's University

Houston, Texas, United States

Countries

United States

Other Identifiers

TWU-1PS

Identifier Type: -

Identifier Source: org_study_id