NCT07337915

Brief Summary

This study purpose of this study to see how consuming pistachios and completing a health intervention session a study therapist may improve sleep health in midlife women with poor sleep. Participants in this study will be asked to consume a study snack for about one month, complete a health education session with a study therapist and record information about their sleep. At baseline and after the intervention we will collect information about sleep, alertness, body composition, and blood lipids.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Feb 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

December 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

December 10, 2025

Last Update Submit

February 27, 2026

Conditions

Poor Sleep Quality

Keywords

Midlife womenSleepInsomnia

Outcome Measures

Primary Outcomes (1)

  • Change in Pittsburgh Sleep Quality Index (PSQI)

    PSQI is a questionnaire that assesses sleep quality, including both subjective experiences and objective parameters. There are 19 questions that are grouped into 7 components to create a global score. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

    Baseline, End of intervention period (up to Week 4)

Secondary Outcomes (23)

  • Change in Seated blood pressure

    Baseline, End of intervention period (up to Week 4)

  • Change in Body Weight

    Baseline, End of intervention period (up to Week 4)

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance

    Baseline, End of intervention (up to Week 4)

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment

    Baseline, End of intervention period (up to Week 4)

  • Change in 24-h Urinary Melatonin

    Baseline, End of intervention period (up to Week 4)

  • +18 more secondary outcomes

Other Outcomes (3)

  • Energy intake assessed 3-day food record

    Baseline

  • Energy intake assessed by 3-day food record

    End of intervention period (up to Week 4)

  • Satisfaction Survey

    End of intervention period (up to Week 4)

Study Arms (3)

Snack 1 + HeathyHabits1

OTHER

Participants in this arm will consume 2 servings of potato chips per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).

Behavioral: HealthyHabits1Other: Snack 1

Snack 2 + HealthyHabits2

OTHER

Participants in this arm will consume 2 servings of pistachios for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve sleep habits.

Behavioral: HealthyHabits2Other: Snack 2

Snack 2 + HealthyHabits1

OTHER

Participants in this arm will consume 2 servings of pistachios per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).

Behavioral: HealthyHabits1Other: Snack 2

Interventions

HealthyHabits1BEHAVIORAL

Participants in this group will be coached in a one hour session with a study therapist how to improve healthy habits (e.g.,diet/nutrition, activity, sleep).

Snack 1 + HeathyHabits1Snack 2 + HealthyHabits1
HealthyHabits2BEHAVIORAL

Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.

Snack 2 + HealthyHabits2
Snack 2OTHER

Participants in this group will consume 2 servings of pistachios daily for 30 days

Snack 2 + HealthyHabits1Snack 2 + HealthyHabits2
Snack 1OTHER

Participants in the group will consume 2 servings of potato chips daily for 30 days.

Snack 1 + HeathyHabits1

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All races and ethnic backgrounds
  • Between the ages of 45-65 years old
  • Women who meet STRAW staging criteria for late peri-menopause (STRAW score of -1) defined as interval of amenorrhea of 60 days OR meet STRAW staging criteria for early post-menopause (STRAW score of +1a, +1b or +1c) defined as \>12 months since last menstrual period
  • History of poor sleep quality (Pittsburgh Sleep Quality Index score \> 5)
  • Able and willing to provide informed consent
  • Access to an electronic device with teleconferencing capabilities (Teams, etc)
  • Willing to consume study intervention
  • Fluent (able to read and write) in English

You may not qualify if:

  • Pregnancy or lactation
  • Recent (within the last 3 months) or current use of any prescription or over the counter medications that may impact sleep quality:
  • including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
  • recent (within the last 3 months) change in antidepressant medication useage or dosage
  • Untreated comorbid sleep disorders that are no known to be responsive to the behavioral interventions: These sleep disorders include but are not limited to narcolepsy, circadian rhythm disorder/shift work, restless leg syndrome, periodic leg movement disorder, obstructive sleep apnea.
  • Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years) that would, in the opinion of the investigator, affect sleep and/or make it difficult for the participant to the investigators instructions.
  • Recent (within past 3 years) treated cancer other than basal cell carcinoma
  • Current adherence to a weight-loss or weight-gain diet or use of GLP-1 RA medications
  • Active or recent (within the past 12 months) alcohol or substance use disorder
  • Allergy to study intervention (tree nuts)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Emily Lantz, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Skinkis, M.Ed

CONTACT

409-772-1907pskinkis@utmb.edu

Emily Lantz, PhD

CONTACT

ejlantz@utmb.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 13, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Deidentified study data that are not designated as restricted use will be made available as public use data to the research community by request to the PIs. Users of the public use data must agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

Locations

US(1)