Pistachio Consumption on Inflammatory Markers and Lean Body Mass

NCT06342024 | Active Not Recruiting

• 1 other identifier: 23-871
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Pistachios; Inflammatory Markers; Lean Body Mass

Outcome Measures

Primary Outcomes (8)

• C-reactive protein concentrations in the blood

  C-reactive protein measures inflammation in the body

  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

• Creatine kinase concentrations in the blood

  Creatine kinase measures muscle damage (inflammation) in the body

  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

• Cortisol concentrations in the blood

  Cortisol measures inflammation in the body

  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

• Interleukin-8 concentrations in the blood

  Interleukin-8 measures inflammation in the body

  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

• Tumor necrosis factor-alpha concentrations in the blood

  Tumor necrosis factor-alpha measures inflammation in the body

  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

• Copper-zinc superoxide dismutase concentrations in the blood

  Copper-zinc superoxide dismutase is an antioxidant

  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

• Glutathione peroxidase concentrations in the blood

  Glutathione peroxidase is an antioxidant

  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

• Lean body mass

  Lean body mass is an anthropometric measurement

  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

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

Study Arms (2)

Arm 1: Pistachio group

EXPERIMENTAL

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).

Other: Pistachio group

Arm 2: No pistachio group

NO INTERVENTION

This group will not get any pistachios.

Interventions

Pistachio group OTHER

Participants will be giving 1.5 ounces of pistachios to consume during the 6-month trial.

Also known as: Not apply

Arm 1: Pistachio group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• smoker
• pregnant or lactating women
• anyone who has a nut allergy

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

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Study Officials

• Stella L Volpe, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not apply
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Model Details: Eligible participants will be randomized to one of two groups (pistachio vs. control) using permuted block randomization with stratification to balance assignment by sex. Randomization allocation tables will be created by a biostatistician not involved in the clinical trial using SAS software, version 9.4 (SAS Institute, Cary, NC, USA). The tables will be stored within the REDCap system at Virginia Tech, in such a way that only the biostatistician will be able to view them. Study outcomes will be analyzed blind to allocation status.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 2, 2024
• Study Start: February 20, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)