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

NCT01928966 | Withdrawn DMC

• 1 other identifier: TWU-1PS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Blood Pressure

Keywords

dietary fat; fat intake; blood pressure; women; phytoestrogen; pumpkin seeds; cardiovascular disease; heart disease; secoisolariciresinol; monounsaturated fat; polyunsaturated fat; feeding study

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I - Pumpkin Seeds

ACTIVE COMPARATOR

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

Group II - Pumpkin Seeds

ACTIVE COMPARATOR

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

Interventions

Pumpkin Seeds 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 I - Pumpkin Seeds; Group II - Pumpkin Seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases

Study Officials

• John D Radcliffe, PhD

  Texas Woman's University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)