- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340125
Pistachio Snacking and Metabolic Flexibility
January 5, 2026 updated by: Katie Hirsch, University of South Carolina
Effects of Pistachio Snacking on Metabolic Flexibility in Healthy Overweight and Obese Adults
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Callie Unrein, MS
- Phone Number: 803-777-5478
- Email: sustainlab@mailbox.sc.edu
Study Locations
-
-
South Carolina
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Columbia, South Carolina, United States, 29208
- Recruiting
- Public Health Research Center: Clinical Exercise Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pistachio
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).
|
Roasted, lightly salted, pistachio kernels (no shell)
|
|
No Intervention: Control
Maintain normal dietary habits for four days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
resting metabolism
Time Frame: Day 0 and Day 5
|
resting metabolic rate (RMR) and substrate utilization (RER) via indirect calorimetry
|
Day 0 and Day 5
|
|
exercise metabolic flexibility
Time Frame: Day 0 and Day 5
|
substrate metabolism (RER; indirect calorimetry) throughout a submaximal, graded exercise test
|
Day 0 and Day 5
|
|
post-exercise metabolism
Time Frame: Day 0 and Day 5
|
Energy expenditure and substrate metabolism (RER) measured at 0, 30, 60, 90min post-exercise via indirect calorimetry
|
Day 0 and Day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caloric Intake
Time Frame: Day 0 and Day 4
|
Average calorie intake (kcal) via 24-hr diet record
|
Day 0 and Day 4
|
|
Carbohydrate Intake
Time Frame: Day 0 and Day 4
|
Average carbohydrate intake (grams) via 24-hr diet record
|
Day 0 and Day 4
|
|
Protein Intake
Time Frame: Day 0 and Day 4
|
Average protein intake (grams) via 24-hr diet record
|
Day 0 and Day 4
|
|
Fat Intake
Time Frame: Day 0 and Day 4
|
Average fat intake (grams) via 24-hr diet record
|
Day 0 and Day 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: daily continuous (Day 0 to Day 5)
|
Daily (24-hr) steps and intensity minutes via wrist activity tracker
|
daily continuous (Day 0 to Day 5)
|
|
Sleep Quantity
Time Frame: Nightly (Day 0 to Day 5)
|
Nightly sleep quantity (total time spent asleep; minutes) via wrist worn activity tracker.
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Nightly (Day 0 to Day 5)
|
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Sleep Quality
Time Frame: Nightly (Day 0 to Day 5)
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Nightly sleep quality (time spent in deep sleep (minutes), REM sleep (minutes), and light sleep (minutes)) via wrist worn activity tracker.
|
Nightly (Day 0 to Day 5)
|
|
Daytime sleepiness
Time Frame: Day 0 and Day 5
|
Subjective likelihood of falling asleep in various situations via Epworth Sleepiness Scale.
In this eight question survey, questions are rated on a scale of 0 (very unlikely) to 3 (very likely), with a total score of 0-9 indicating low daytime sleepiness, 10-15 indicating moderate daytime sleepiness, and 16-24 indicating severe daytime sleepiness.
|
Day 0 and Day 5
|
|
Subjective hunger
Time Frame: Daily (Day 1 to Day 4)
|
Degree of hunger/fullness (Visual Analog Scale) mid-morning (post-snack), late morning (a few hours post snack), and mid-afternoon (pre-snack).
|
Daily (Day 1 to Day 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katie R Hirsch, PhD, University of South Carolina
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 Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
December 17, 2025
First Submitted That Met QC Criteria
January 5, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00145186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
data may be shared upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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