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CLINICAL STUDY · NCT07880444

Effects of Daily Avocado Consumption on Sleep and Skin Health in Postmenopausal Females

Not yet recruitingNot applicableInterventional

Sponsored by San Diego State University

Condition
Poor Sleep Quality
Study locations
None reported
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

Poor sleep quality and accelerated skin aging are common in postmenopausal women and may be linked, in part, through impaired vascular function. Avocados contain monounsaturated fats, carotenoids, vitamin E, magnesium, fiber, and other bioactive compounds that may support vascular health and, in turn, improve sleep and skin health. This randomized controlled trial will evaluate whether consuming one medium Hass avocado daily for 8 weeks improves sleep quality and skin health compared with a calorie- and fatty-acid-matched safflower oil control in postmenopausal women with poor sleep quality and overweight or obesity. The study will enroll 74 postmenopausal women aged 50-65 years who have poor habitual sleep quality. Participants will be randomly assigned to consume either one medium Hass avocado per day or 27 g of safflower oil per day for 8 weeks. Sleep will be assessed using wrist actigraphy, at-home electroencephalography, sleep diaries, and validated sleep questionnaires. Skin hydration, elasticity, barrier function, collagen, pigmentation, and wrinkles will also be assessed. Vascular function will be measured using flow-mediated dilation and blood biomarkers. The investigators expect that daily avocado consumption will improve sleep quality, skin health, and vascular function compared with the control condition and will explore whether improvements in vascular function contribute to improvements in sleep and skin health.
Full official title
Sleep and Skin Health Improvement Via Avocado-Induced Vascular Endothelial Responses in Postmenopausal Females With Poor Sleep
Detailed description
This study is an 8-week, randomized, parallel-group controlled trial designed to evaluate the effects of daily Hass avocado consumption on sleep quality, skin health, and vascular function in postmenopausal women with poor habitual sleep quality and overweight or obesity. A total of 74 women aged 50-65 years will be randomized to either an Avocado Arm or a calorie- and fatty-acid-matched Control Arm. Participants assigned to the Avocado Arm will consume one medium Hass avocado daily (150 g pulp; approximately 240 kcal) for 8 weeks. Participants assigned to the Control Arm will consume 27 g of safflower oil daily (approximately 243 kcal) for 8 weeks. Study foods will be consumed with breakfast or lunch while participants otherwise maintain their habitual diet. The control was selected to provide a similar amount of energy and a predominantly monounsaturated fatty-acid profile while lacking the fiber, carotenoids, minerals, phytosterols, and other components of the whole avocado matrix. Study assessments will be conducted at baseline, Week 4, and Week 8. Objective sleep quality will be assessed using 7-day wrist actigraphy to measure sleep efficiency, sleep fragmentation, sleep duration, sleep latency, nighttime awakenings, and wake after sleep onset. On the final night of each assessment period, participants will complete one night of at-home electroencephalography using the Zmachine Insight device to assess sleep architecture, including slow-wave sleep. Subjective sleep will be assessed using sleep diaries and validated questionnaires, including the Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, and Ru-SATED multidimensional sleep health scale. Skin health will be assessed under standardized environmental conditions. Outcomes will include skin hydration, elasticity, transepidermal water loss, sebum, pigmentation, wrinkle severity, surface texture, and collagen integrity. Measurements will be obtained at the forehead, periorbital region, dorsal hand, and upper inner arm using noninvasive skin-assessment instruments. Participants will also complete a questionnaire assessing skin-related quality of life. Vascular function will be evaluated as a potential biological pathway linking avocado consumption with changes in sleep and skin health. Macrovascular endothelial function will be assessed using brachial artery flow-mediated dilation. Fasting blood samples will also be analyzed for markers of endothelial activation, inflammation, and oxidative stress, including VCAM-1, ICAM-1, P-selectin, E-selectin, C-reactive protein, total antioxidant capacity, and 8-oxo-deoxyguanosine. The primary hypothesis is that daily avocado consumption will improve sleep quality and skin health compared with the calorie- and fatty-acid-matched control. The study will also examine whether changes in vascular function during the intervention are associated with subsequent improvements in sleep and skin outcomes.

PARTICIPATION

Who may participate

Minimum age
50 Years
Maximum age
65 Years
Sex eligibility
Female
Healthy volunteers
Accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria
Inclusion Criteria:

* Postmenopausal women aged 50-65 years
* Individuals with overweight or obesity, defined as BMI 25-35 kg/m²
* Postmenopausal, defined as no menstrual period for at least 12 months
* Participants with poor habitual sleep quality, reflected by a global score \>5 on the Pittsburgh Sleep Quality Index (PSQI)
* Participants with Fitzpatrick skin types II-IV
* Participants willing to maintain their usual skin-care routine throughout the study, avoid excessive sun exposure, and not initiate new skin treatments

Exclusion Criteria:

* Current smokers
* Individuals with caffeine intake \>300 mg/day
* Excessive alcohol or drug use
* Individuals engaged in shift work
* Current use of hormone replacement therapy
* Individuals with chronic pain or major chronic disease/medication likely to affect study outcomes, including uncontrolled hypertension, prediabetes/type 2 diabetes, chronic kidney disease, COPD, autoimmune disease, recent cardiovascular event, or cancer within the past 24 months
* Psychiatric or neurologic disease/disorder likely to affect sleep
* Individuals with a diagnosed sleep disorder or high risk for sleep apnea, defined as a STOP-Bang score ≥3
* Individuals using medications to regulate sleep
* Individuals planning time-zone travel during the study
* Pregnancy or lactation
* Allergy or intolerance to study foods
* Individuals who dislike avocado and/or safflower oil, defined as a taste pleasantness rating \<50 mm on a 100-mm visual analog scale
* Individuals who habitually consume \>2 avocados per month

NEAR YOU

Study locations worldwide

0 sites

Check the individual site’s status and contact the listed study team for current availability.

No study sites are currently reported in this record. Location information may have changed.

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

Hass AvocadoOther
One medium Hass avocado (150 g pulp) consumed once daily for 8 weeks.

Study groups: Avocado Arm (AA)

Safflower OilOther
A 27-g portion of safflower oil consumed once daily for 8 weeks.

Study groups: Safflower Oil Control Arm

Study groups

Avocado Arm (AA)Experimental
Participants will consume one medium Hass avocado daily (150 g pulp; approximately 240 kcal) for 8 weeks. The avocado will be consumed with breakfast or lunch while participants maintain their habitual diet.

Interventions: Other: Hass Avocado

Safflower Oil Control ArmActive comparator
Participants will consume 27 g of safflower oil daily (approximately 243 kcal) for 8 weeks. The control is designed to approximate the avocado intervention for energy and fatty-acid profile while lacking the avocado whole-food matrix. The safflower oil will be consumed with breakfast or lunch while participants maintain their habitual diet.

Interventions: Other: Safflower Oil

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Study model
Parallel
Masking
Single
Enrolment
74 participants · Estimated
Who is masked
Investigator

Study model details

A two-arm, randomized, double-blind, placebo-controlled parallel assignment in which participants allocated to either the avocado or control group and remained in the same group for the duration of the 8-week intervention.

Masking details

Statistician will be masked to study condition. Participants cannot be masked Participants will be instructed not to disclose their assigned group to masked staff. Other personnel involved in the study cannot be masked.

TIMELINE & MEASURES

Dates and outcomes

Study started
1 Jan 2027 · Estimated
Primary completion
Apr 2029 · Estimated
Study completion
Apr 2029 · Estimated
First registered
19 Oct 2026 · Actual
Last registry update
19 Oct 2026 · Actual
Status last verified
Oct 2026
Primary outcomes (4)

Change in Actigraphy-Derived Sleep Efficiency

Sleep efficiency will be assessed using 7-day wrist actigraphy and expressed as the percentage of time in bed spent asleep. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Slow-Wave Sleep Duration

Slow-wave (N3) sleep will be assessed using one night of at-home electroencephalography with the Zmachine Insight device and expressed as minutes and percentage of total sleep time. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Actigraphy-Derived Sleep Fragmentation Index

Sleep fragmentation will be assessed using 7-day wrist actigraphy. Higher values indicate greater sleep fragmentation. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Skin hydration

Skin hydration will be measured using corneometry at the forehead, periorbital region, dorsal hand, and upper inner arm. Values will be expressed in arbitrary units, with higher values indicating greater hydration. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Secondary outcomes (23)

Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Insomnia Severity Index (ISI) Score

Insomnia severity will be assessed using the Insomnia Severity Index (ISI). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Epworth Sleepiness Scale (ESS) Score

Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Ru-SATED Multidimensional Sleep Health Score

Multidimensional sleep health will be assessed using the RU-SATED Sleep Health Scale. Total scores range from 0 to 12, with higher scores indicating better sleep health. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Skin elasticity

Skin elasticity will be measured using an ElastiMeter® (Delfin Technologies Ltd., Kuopio, Finland). Instant Skin Elasticity (ISE) will be reported in newtons per meter (N/m), with higher values indicating greater skin elasticity. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Transepidermal water loss (TEWL)

Skin barrier function will be assessed by transepidermal water loss using a VapoMeter® and reported in g·m-²·h-¹. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Skin Sebum Content

Skin sebum content will be measured using a Sebumeter® and reported in micrograms per square centimeter (µg/cm²), with higher values indicating greater skin surface sebum content. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Skin Pigmentation

Skin pigmentation will be assessed using Antera 3D® imaging (Miravex Ltd., Ireland). Average pigmentation concentration will be reported in arbitrary units (AU), with higher values indicating greater skin pigmentation. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Wrinkle Severity

Average wrinkle depth will be assessed using Antera 3D® imaging (Miravex Ltd., Ireland) and reported in millimeters (mm), with higher values indicating deeper wrinkles. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Collagen integrity

Dermal collagen will be assessed noninvasively using the Dermo® collagen measurement device (Mondray Technologies, Greenwich, CT). The device uses spatially resolved spectroscopy to derive a collagen measurement from the optical scattering properties of the dermis. Collagen values are reported on a device-derived scale ranging from 10 to 99, with higher values indicating greater dermal collagen content. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Menopausal Skin Quality of Life (MSkinQOL) Scores

The 28-item questionnaire assesses three dimensions: health status, self-esteem, and social effects of skin appearance. Items are rated on a 5-point scale from 0 (never) to 4 (always), with higher scores indicating greater symptom frequency or greater negative impact on quality of life. Change from baseline in MSkinQOL dimension scores will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Flow-mediated dilation (FMD)

Brachial artery endothelial function will be assessed using ultrasound-based flow-mediated dilation following 5 minutes of forearm cuff occlusion. FMD will be expressed as the absolute and percentage change in brachial artery diameter from pre-occlusion baseline to the post-occlusion peak diameter. Change from baseline in FMD will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Carotid-Femoral Pulse Wave Velocity (PWV)

Arterial stiffness will be assessed using carotid-femoral pulse wave velocity. Pulse transit time will be determined from carotid and femoral arterial waveforms, and pulse wave velocity will be calculated as distance traveled divided by transit time and expressed in meters per second (m/s). Higher values indicate greater arterial stiffness. Change from baseline will be assessed at each follow-up

Time frame: Baseline, Week 4, Week 8

Height

Standing height will be measured in centimeters (cm) using a calibrated stadiometer

Time frame: Baseline

Change in Body Weight

Body weight will be measured in kilograms (kg) using a calibrated digital scale. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Body Mass Index (BMI)

BMI will be calculated as weight (kg) divided by height squared (m²). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Intercellular Adhesion Molecule-1 (ICAM-1)

Fasting circulating intercellular adhesion molecule-1 (ICAM-1) concentration will be measured in serum using an ELISA and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)

Fasting circulating vascular cell adhesion molecule-1 (VCAM-1) concentration will be measured in serum using an enzyme-linked immunosorbent assay (ELISA) and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in P-Selectin

Fasting circulating P-selectin concentration will be measured in serum using an ELISA and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in E-Selectin

Fasting circulating E-selectin concentration will be measured in serum using an ELISA and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in C-Reactive Protein (CRP)

Fasting serum C-reactive protein (CRP) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in 8-Hydroxy-2'-Deoxyguanosine (8-OHdG)

Fasting serum 8-oxo-2'-deoxyguanosine (8-oxodG), a marker of oxidative DNA damage, will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in nanograms per milliliter (ng/mL). Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

Change in Total Antioxidant Capacity

Fasting serum total antioxidant capacity will be measured using a colorimetric antioxidant capacity assay and reported in millimoles per liter (mmol/L) as Trolox equivalents. Change from baseline will be assessed at each follow-up.

Time frame: Baseline, Week 4, Week 8

STUDY TEAM

Sponsor and contacts

Lead sponsor
San Diego State University
Sponsor type
Other
Collaborators
Not reported
Organisation study ID
IRB-26-373

Central study contacts

Surabhi Bhutani, PhDContactPhone: 619-594-4094Email: sbhutani@sdsu.edu
Study officials
Surabhi BhutaniPrincipal investigator · San Diego State University
Meeyoung HongPrincipal investigator · San Diego State University

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Source: ClinicalTrials.gov · Data fetched 20 Oct 2026, 16:42 GMT+0530

Registry data timestamp: 2026-10-19T09:00:04

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

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