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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Primary Research Objectives:
- To examine the effects of a diet rich in pistachios on body composition
- Examine incorporation of healthy fats into red blood cell (RBC) membranes
- Determine changes in blood lipids, inflammatory markers and markers of bone turnover with pistachio consumption
- Assess diet quality/micronutrient quality and satiety with pistachio consumption
Methods Investigators will employ a crossover design with two 12-week treatment periods (pistachio added and a no-pistachio control diet), separated by 15-week washout period, with 30 healthy students at each campus.
Subjects Female students enrolled at CP-SLO and CP-P will be invited to participate in the study. The first 30 qualified females will be enrolled in the study at each site. A screening questionnaire will determine eligibility. The interview will take ~5 minutes. This sample size provides more than adequate power (80%) to detect individual changes.
Recruitment Female students enrolled at CP-SLO and CP-P will be invited to participate in the study. Potential subjects will be notified by flyers, emails, adds on marquees, and peer recruitment in summer school classes. The information on the flyer and emails will be approved by the Institutional Review Boards and contain information regarding inclusion/exclusion criteria, length of study, and the risks and benefits. Participants will be asked to contact either Dr. Laura Hall (CP-SLO) or Dr. Bonny Burns-Whitmore (CP-P) and then potential participants will be asked to fill out a screening questionnaire to determine eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cal Poly, SLO or Pomona biological female students (Age 18-40 yrs, BMI 18.5-25).
- •Must like eating pistachios.
- •Free of chronic diseases.
排除标准
- •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
- •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.
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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)
研究者
Dr. Bonny Burns-Whitmore, RD
Full Tenured Professor of Nutrition/Graduate Coordinator
California State Polytechnic University, Pomona