NCT07340125

Brief Summary

The purpose of this study is to evaluate the effects of pistachio snacking on metabolic flexibility (at rest, during exercise, and in post-exercise recovery) in healthy overweight and obese adults. Secondary goals include evaluating effects on changes in diet quality, sleep characteristics, physical activity, and hormonal health in women. In randomized order, participants will complete four days of pistachio snacking and four days of normal dietary habits (control). For both conditions, primary outcomes of resting substrate metabolism, metabolic flexibility during exercise, and post-exercise substrate metabolism will be measured pre-post intervention via indirect calorimetry. Secondary outcome of diet quality (kcal, carb, fat, protein) will be measured pre-post intervention via diet log. Exploratory outcomes of daily physical activity (steps, intensity), nightly sleep characteristics (quantity, quality, latency, efficiency), and daytime sleepiness and hunger.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 17, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

PistachioTree Nutsmetabolic flexibilitymetabolismdiet qualitysnacking

Outcome Measures

Primary Outcomes (3)

  • resting metabolism

    resting metabolic rate (RMR) and substrate utilization (RER) via indirect calorimetry

    Day 0 and Day 5

  • exercise metabolic flexibility

    substrate metabolism (RER; indirect calorimetry) throughout a submaximal, graded exercise test

    Day 0 and Day 5

  • post-exercise metabolism

    Energy expenditure and substrate metabolism (RER) measured at 0, 30, 60, 90min post-exercise via indirect calorimetry

    Day 0 and Day 5

Secondary Outcomes (4)

  • Caloric Intake

    Day 0 and Day 4

  • Carbohydrate Intake

    Day 0 and Day 4

  • Protein Intake

    Day 0 and Day 4

  • Fat Intake

    Day 0 and Day 4

Other Outcomes (5)

  • Physical Activity

    daily continuous (Day 0 to Day 5)

  • Sleep Quantity

    Nightly (Day 0 to Day 5)

  • Sleep Quality

    Nightly (Day 0 to Day 5)

  • +2 more other outcomes

Study Arms (2)

Pistachio

EXPERIMENTAL

Four days of pistachio snacking, to be consumed mid-morning (1oz; 9-11am), mid-afternoon (1oz; 2-4pm), and pre-sleep (0.5 oz; within 1hr of bedtime), while otherwise maintaining normal dietary habits. An addition snack will be consumed post-exercise (0.5oz).

Other: Pistachio

Control

NO INTERVENTION

Maintain normal dietary habits for four days.

Interventions

Roasted, lightly salted, pistachio kernels (no shell)

Pistachio

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females
  • Age: 25-45 years
  • Overweight or obese (BMI=25.0-34.9 kg/m²)
  • Poor sleep quality (Pittsburgh Sleep Quality Index ≥ 5)
  • Healthy (no diagnosed metabolic, cardiovascular, sleep, or other health condition that may significantly alter metabolism, sleep, or ability to participate in the exercise test)
  • Not meeting weekly physical activity recommendations (\<150 min moderate-intensity exercise, \<75 minutes of vigorous-intensity exercise, and \<2 days of strength training)
  • Not following a diet that is restrictive or eliminates certain food group/types

You may not qualify if:

  • Allergies to nuts, especially tree nuts
  • Has a pacemaker
  • Following a diet that is restrictive or eliminates certain food group/types
  • Self-repoted health or disease state that may influence study outcomes, including known metabolic or endocrine disorder (e.g. prediabetes, type 1 or type 2 diabetes, or polycystic ovary syndrome), cardiovascular diseases, neuromuscular disorders, musculoskeletal disorders; current or recent history of cancer/cancer treatment (within the past year)
  • History of gastrointestinal surgery, hysterectomy
  • For women: pregnant or thinking of becoming pregnant during the time of participation, pregnant within the last year, currently breastfeeding, or known to be perimenopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Center: Clinical Exercise Research Center

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katie R Hirsch, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 14, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

data may be shared upon reasonable request.

Locations