Effects of Pistachio Consumption on Body Composition and Blood and Bone Indicators

NCT02849392 | Completed

• 2 other identifiers: 002940-CPP Foundation082012-CPSLO ARI
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Pistachio; Body composition; Erythrocyte membrane incorporation of fatty acids; Dietary quality/micronutrient quality; Blood lipids; Inflammatory markers; Bone density; Bone turnover markers; Satiety

Outcome Measures

Primary Outcomes (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.

  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

  24 weeks-12 weeks intervention, 12 weeks no intervention

Secondary Outcomes (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.

  24 weeks-12 weeks intervention, 12 weeks no intervention

Other Outcomes (3)

• 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.

  24 weeks-12 weeks intervention, 12 weeks no intervention

• 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.

  24 weeks-12 weeks intervention, 12 weeks no intervention

• 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.

  24 weeks-12 weeks intervention, 12 weeks no intervention

Study Arms (2)

Pistachio

EXPERIMENTAL

Pistachio added 20% of kcals to diet

Other: Pistachio added 20% of kcals to diet

No Pistachio

NO INTERVENTION

No pistachios in diet (control)

Interventions

Pistachio added 20% of kcals to diet OTHER

Pistachio added 20% of kcals to diet

Pistachio

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• California State Polytechnic University, Pomona: lead
• California Polytechnic State University-San Luis Obispo: collaborator
• California State University Agricultural Research Institute (ARI): collaborator
• American Pistachio Growers: collaborator

Related Links

• MAYO CLINIC
• NDS-R Software

Study Officials

• Mary Oates, MD

  California Polytechnic University-San Luis Obispo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Tenured Professor of Nutrition/Graduate Coordinator

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 29, 2016
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share