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Pumpkin Seed Oil Supplementation in Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119429
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University

Brief Summary:
The purpose of this study is to determine whether or not there is an effect of pumpkin seed oil supplementation, 2 grams per day, on blood pressure (systolic and diastolic) in premenopausal women.

Condition or disease Intervention/treatment Phase
Blood Pressure Dietary Supplement: Pumpkin Seed Oil Dietary Supplement: Wheat Germ Oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Pumpkin Seed Oil Supplementation on Blood Pressure in Premenopausal Women
Study Start Date : April 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Placebo Comparator: Wheat Germ Oil
Participants will be instructed to consume 2 wheat germ oil capsules ,2g, per day for 12 weeks.
Dietary Supplement: Wheat Germ Oil
2 grams per day, everyday for 12 weeks.

Experimental: Pumpkin Seed Oil
Participants will be instructed to consume 2 pumpkin seed oil capsules ,2g, per day for 12 weeks
Dietary Supplement: Pumpkin Seed Oil
2 grams per day, everyday for 12 weeks.




Primary Outcome Measures :
  1. Change From Baseline Systolic Blood Pressure at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  2. Change From Baseline Diastolic Blood Pressure at 12 weeks [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Baseline ]
    BMI is an important measurement to record because an increase in weight may be accompanied by an increase in blood pressure.

  2. Percent Body Fat [ Time Frame: Baseline ]
    Percent body fat is an important measurement to record because an increase in body fat may be accompanied by an increase in blood pressure.

  3. Nutrient content of diet [ Time Frame: Baseline ]
    Participants will be given instructions on how to keep a 3-day diet and supplement diary. A booklet will be provided to help them record their diet for two nonconsecutive week days and one weekend day. Diet will then be analyzed using Minnesota Nutrition Data System for calories, carbohydrate, protein, fat, vitamins, minerals, and phytoestrogen content.

  4. Phytoestrogen content of diet [ Time Frame: Baseline ]
    A food frequency questionnaire will be given to each participants to assess the phytoestrogen content of her diet.

  5. Activity Level [ Time Frame: Baseline ]
    The purpose of the physical activity questionnaire is to establish each participant's activity level because physical activity level may have an effect on blood pressure.

  6. Body Mass Index (BMI) [ Time Frame: 12 weeks ]
    BMI is an important measurement to record because an increase in weight may be accompanied by an increase in blood pressure.

  7. Percent Body Fat [ Time Frame: 12 weeks ]
    Percent body fat is an important measurement to record because an increase in body fat may be accompanied by an increase in blood pressure.

  8. Nutrient content of diet [ Time Frame: 12 weeks ]
    Participants will be given instructions on how to keep a 3-day diet and supplement diary. A booklet will be provided to help them record their diet for two nonconsecutive week days and one weekend day. Diet will then be analyzed using Minnesota Nutrition Data System for calories, carbohydrate, protein, fat, vitamins, minerals, and phytoestrogen content.

  9. Phytoestrogen content of diet [ Time Frame: 12 weeks ]
    A food frequency questionnaire will be given to each participants to assess the phytoestrogen content of her diet.

  10. Activity Level [ Time Frame: 12 weeks ]
    The purpose of the physical activity questionnaire is to establish each participant's activity level because physical activity level may have an effect on blood pressure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Read, speak, and write English
  • Premenopausal

Exclusion Criteria:

  • Consuming estrogen supplements
  • Taking hypertensive blood pressure medication
  • Consuming pumpkin seed oil supplements
  • Consuming pumpkin seeds more than once a month
  • Wheat allergy or gluten intolerance
  • Blood pressure > 140/90 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119429


Locations
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United States, Texas
Texas Woman's University, Institute of Health Sciences- Houston Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Samantha L Caudill, BS Texas Woman's University
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Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT02119429    
Other Study ID Numbers: 17411a
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: December 2014
Keywords provided by Texas Woman's University:
Blood pressure
Pre-menopausal
Supplementation