Effects of Pistachio Consumption on Inflammatory Markers and Lean Body Mass in Recreationally Active Women and Men
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Cortisol concentrations in the blood
研究概览
简要总结
Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.
The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.
This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.
The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition.
详细描述
The overall goal of the study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. To determine the effects of consuming 1.5 ounces of pistachios per day compared to a control group on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week).
This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day versus a control (consuming no pistachios). The pistachios will be in addition to their usual diet.
Dietary Intervention including Dietary Evaluation The dietary intervention will be to randomly assign 144 participants to consume 1.5 ounces of pistachios per day (72 participants) or a control group (consuming no pistachios) (72 participants). That will be the only change will be implemented into the participants' diets. Because a number of researchers have shown that adding pistachios to the diet does not lead to weight gain, participants will not be asked to alter their diets in any way, except to add consumption of 1.5 ounces of pistachios per day for six months, or have no change in their diet (control group) (depending on the group to which they were randomly assigned).
Two-week Baseline Run-in Period A two-week baseline run-in period will be incorporated during which participants will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). The pistachios will be in addition to their usual diet.
Why incorporate a two-week baseline run-in period? First, a run-in period is used after recruitment, but prior to randomizing participants. With a run-in period, even if there will be no treatment during the run-in period (as in our study), it allows the researchers to assess participant participation prior to randomization. If a participant is not receptive to any contact (e.g., emails, phone calls) during the run-in period, it will allow the researchers to exclude them from participating, which can increase the study's power. However, a run-in period might lead to negative effects. It could influence external validity by excluding participants from the study. A run-in period could also affect internal validity by inflating the intent-to-treat effect estimate. In addition, researchers should report why any participants were excluded during the run-in period, and describe their baseline characteristics in any publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Not apply
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women and men, 40 to 60 years of age
- •exercise three to five days a week for at least the past six months
- •non-smokers
- •not be on an active weight loss program at the start of the study or any time during the study
- •willing to maintain and not change their usual exercise habits
- •willing to consume pistachios as part of their diet (should they be randomized into the pistachio group)
排除标准
- •unwilling to sign the informed consent document
- •not exercising regularly, three to five times per week for at least the past six months
- •physician states that they are not able to participate in the study
- •already consuming one or more ounces of pistachios several times a week
- •pregnant or lactating women
- •anyone who has a nut allergy
研究组 & 干预措施
Arm 1: Pistachio group
Participants will receive 1.5 ounces of pistachios to consume every day for 6 months. We will provide them a 3-month supply of pistachios, and they will receive another 3-month supply when they come in for their 3-month study visit (blood draw).
干预措施: Pistachio group (Other)
Arm 2: No pistachio group
This group will not get any pistachios.
结局指标
主要结局
Cortisol concentrations in the blood
时间窗: Cortisol (mcg/dL) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Cortisol measures inflammation in the body
Interleukin-8 concentrations in the blood
时间窗: Interleukin-8 (pg/mL) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Interleukin-8 measures inflammation in the body
Copper-zinc superoxide dismutase concentrations in the blood
时间窗: Copper-zinc superoxide dismutase (U/mL) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Copper-zinc superoxide dismutase is an antioxidant
C-reactive protein concentrations in the blood
时间窗: C-reactive protein (mg/dL) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
C-reactive protein measures inflammation in the body
Creatine kinase concentrations in the blood
时间窗: Creatine kinase (U/L) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Creatine kinase measures muscle damage (inflammation) in the body
Tumor necrosis factor-alpha concentrations in the blood
时间窗: Tumor necrosis factor-alpha (pg/mL) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Tumor necrosis factor-alpha measures inflammation in the body
Glutathione peroxidase concentrations in the blood
时间窗: Glutathione peroxidase (U/mg protein) in the blood will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group
Glutathione peroxidase is an antioxidant
Lean body mass
时间窗: Lean body mass (kg) will be measured at baseline and 6 months to assess change over time between the pistachio group and the placebo group
Lean body mass is an anthropometric measurement
次要结局
- Magnesium concentrations in the blood(Magnesium (mg/dL) will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group)
- Body Mass Index(Body Mass Index (kg/m2) will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group)
- Body weight(Body weight (kg) will be will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group)
- Height(Height (cm) will be measured at baseline only, because differences are not expected in this adult population)
- Iron concentrations in the blood(Iron (mcg/dL) will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group)
- Zinc concentrations in the blood(Zinc (mcg/dL) will be measured at baseline, 3 and 6 months to assess change over time between the pistachio group and the placebo group)
研究者
Stella L. Volpe, PhD
Professor and Department Head
Virginia Polytechnic Institute and State University