Pistachio Consumption on Inflammatory Markers and Lean Body Mass
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.
Conditions:
🦠 Inflammatory Response
🗓️ Study Start (Actual) 20 February 2024
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 31 August 2025
👥 Enrollment (Estimated) 144
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Blacksburg, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. women and men, 40 to 60 years of age
    • 2. exercise three to five days a week for at least the past six months
    • 3. non-smokers
    • 4. not be on an active weight loss program at the start of the study or any time during the study
    • 5. willing to maintain and not change their usual exercise habits
    • 6. willing to consume pistachios as part of their diet (should they be randomized into the pistachio group)

    Exclusion Criteria:

    • 1. unwilling to sign the informed consent document
    • 2. not exercising regularly, three to five times per week for at least the past six months
    • 3. physician states that they are not able to participate in the study
    • 4. already consuming one or more ounces of pistachios several times a week
    • 5. smoker
    • 6. pregnant or lactating women
    • 7. anyone who has a nut allergy
Ages Eligible for Study: 40 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 March 2024
  • First Submitted that Met QC Criteria 25 March 2024
  • First Posted 2 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 March 2024
  • Last Update Posted 2 April 2024
  • Last Verified March 2024