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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01928966
Other study ID # TWU-1PS
Secondary ID
Status Withdrawn
Phase N/A
First received August 21, 2013
Last updated May 24, 2017
Start date August 2013
Est. completion date November 2014

Study information

Verified date May 2017
Source Texas Woman's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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).

Locations

Country Name City State
United States Texas Woman's University Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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