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Effects of Pistachio Consumption on Body Composition and Blood and Bone Indicators (CPsPistachio)

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ClinicalTrials.gov Identifier: NCT02849392
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborators:
California Polytechnic State University-San Luis Obispo
California State University Agricultural Research Institute (ARI)
American Pistachio Growers
Information provided by (Responsible Party):
Dr. Bonny Burns-Whitmore, RD, California State Polytechnic University, Pomona

Brief Summary:
Research investigating beneficial effects of regular pistachio feedings on body composition (BC) and blood lipids are limited, and there are no studies that have investigated the effects of feeding pistachios on bone density or membrane incorporation of fats. The purpose of this study is to examine the effects of pistachio consumption on body composition, bone density, markers of bone turnover, erythrocyte membrane incorporation of fatty acids, lipid status, inflammatory markers, dietary quality/micronutrients and satiety using a cross-over study with two 12-week treatment periods (pistachio added (20 percent of kcals) and a no-pistachio control diet), separated by 15-week washout period. The investigators will recruit 30 female students from Cal Poly, San Luis Obispo (CP-SLO) and female 30 students from Cal Poly, Pomona (CP-P) facilitating a collaborative project and using the expertise of both Dr. Laura Hall (CP-SLO) and Dr. Bonny Burns-Whitmore (CP-P). The investigators hope to show the health benefits of pistachios as part of an overall healthy lifestyle.

Condition or disease Intervention/treatment Phase
Healthy Other: Pistachio added 20% of kcals to diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effects of Pistachio Consumption on Body Composition, Blood Lipids, Bone Density, Satiety, Inflammatory Markers, and Erythrocyte Membrane Incorporation of Fatty Acids (The Cal Polys Pistachio Study)
Study Start Date : March 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arm Intervention/treatment
Experimental: Pistachio
Pistachio added 20% of kcals to diet
Other: Pistachio added 20% of kcals to diet
Pistachio added 20% of kcals to diet

No Intervention: No Pistachio
No pistachios in diet (control)



Primary Outcome Measures :
  1. Change from baseline in body composition as measured with the Tanita scale TBF-310 at week 12 as compared to change in body composition from baseline with inclusion of 20% Kcals from pistachios measured at week 12. [ Time Frame: 24 weeks-12 weeks intervention, 12 weeks no intervention ]
    Changes in body composition will be determined by the Tanita scale and/or by DXA differences from baseline to end in the pistachio intervention as compared to not consuming 20% Kcals of pistachios for 12 weeks


Secondary Outcome Measures :
  1. Change from baseline in RBC membrane fatty acids as measured by Lipomics technology at week 12 as compared to change in RBC membranes from baseline to 12 weeks when consuming 20% of diet kcals from pistachios. [ Time Frame: 24 weeks-12 weeks intervention, 12 weeks no intervention ]
    Using Lipomics laboratory patented technology (Metabolomics now) they will determine the fatty acid incorporation into red blood cell (RBC) membranes differences from baseline to end in the pistachio intervention as compared to not consuming pistachios for 12 weeks


Other Outcome Measures:
  1. Change from baseline in blood lipids, inflammatory and bone markers as measured by a contracted laboratory at week 12 as compared to change from baseline to week 12 when consuming 20% of diet kcals from pistachios. [ Time Frame: 24 weeks-12 weeks intervention, 12 weeks no intervention ]
  2. Change in diet quality as measured by the NDS-R Software during the diet record keeping periods (3 times each arm for 3 days) during the 12 weeks for 20% dietary Kcals from pistachios and for the no-pistachio treatment arm. [ Time Frame: 24 weeks-12 weeks intervention, 12 weeks no intervention ]
    The NDS-R Software is produced by the University of Minnesota Reagants. Diets were randomized for each participant 3 times for 3 days each during each of the 12 week arms. This resulted in 18 total diet records for each participant.

  3. Change in satiety as measured by the Visual Analog Scales (VAS) during the diet record keeping periods (3 times each arm for 3 days) during the 12 weeks for 20% dietary Kcals from pistachios and for the no-pistachio treatment arm. [ Time Frame: 24 weeks-12 weeks intervention, 12 weeks no intervention ]
    Diets were randomized for each participant 3 times for 3 days each during each of the 12 week arms, and the VAS satiety questionnaire was used to measure satiety when pistachios were consumed or at a randomized meal if the participant was not consuming pistachios in that treatment arm.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cal Poly, SLO or Pomona biological female students (Age 18-40 yrs, BMI 18.5-25).
  • Must like eating pistachios.
  • Free of chronic diseases.

Exclusion Criteria:

  • Non-Cal Poly students and males.
  • Allergies to pistachios or other nuts.
  • Eat excessive amounts of nuts.
  • Less than 18 yrs old or older than 40 yrs.
  • Female BMI less than 18.5 or greater than 25.
  • Any disease or underlying condition that requires treatment that may affect metabolism, normal dietary intake or physical activity levels.
  • Use of medications that affect fat malabsorption, use of laxatives, liver disease, kidney disease, thyroid disease, Diabetes, hypertension, dyslipidemia, or pregnancy, cancer.
  • Pacemakers or metal pins or plates in the body
  • Unwillingness to follow study protocol
  • Must avoid eating other nuts, fish oil and flax seed/oil.
  • Any chronic disease.
  • Excessive consumption of alcohol.
  • Elite Athletes will be excluded.

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): NCT02849392


Sponsors and Collaborators
California State Polytechnic University, Pomona
California Polytechnic State University-San Luis Obispo
California State University Agricultural Research Institute (ARI)
American Pistachio Growers
Investigators
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Study Director: Mary Oates, MD California Polytechnic University-San Luis Obispo

Additional Information:
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Responsible Party: Dr. Bonny Burns-Whitmore, RD, Full Tenured Professor of Nutrition/Graduate Coordinator, California State Polytechnic University, Pomona
ClinicalTrials.gov Identifier: NCT02849392     History of Changes
Other Study ID Numbers: 002940-CPP Foundation
082012-CPSLO ARI ( Other Grant/Funding Number: California Agriculture Research Institute )
002940-CPP Foundation ( Other Grant/Funding Number: American Pistachio Growers )
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: lipid and blood data
Keywords provided by Dr. Bonny Burns-Whitmore, RD, California State Polytechnic University, Pomona:
Pistachio
Body composition
Erythrocyte membrane incorporation of fatty acids
Dietary quality/micronutrient quality
Blood lipids
Inflammatory markers
Bone density
Bone turnover markers
Satiety