Recruiting

Pistachios

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07337915

Conditions

Poor Sleep Quality

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

Interventions

HealthyHabits1

HealthyHabits2

Snack 2

Snack 1

Study Details

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.

Conditions

Poor Sleep Quality

Study ID

NCT07337915

Start date

Feb 16, 2026

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

1. including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
2. 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)
  • Any other condition or event considered exclusionary by study PI

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Snack 1 + HeathyHabits1

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).

other: Snack 2 + HealthyHabits2

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.

other: Snack 2 + HealthyHabits1

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).

Interventions

HealthyHabits1

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).

HealthyHabits2

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

Snack 2

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

Snack 1

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

Primary outcome measure

  • Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, End of intervention period (up to Week 4) ]

Central Contacts and Locations

Central contacts

Paula Skinkis, M.Ed

409-772-1907pskinkis@utmb.edu

Emily Lantz, PhD

ejlantz@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Paula Skinkis, M.Ed

409-772-1907pskinkis@utmb.edu

Emily Lantz, PhD

409-772-0643ejlantz@utmb.edu

Principal Investigator:

Emily J Lantz, PhD

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Midlife women
  • Sleep
  • Insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-03-03.