An interventional study of Hass Avocado and Safflower Oil in Poor Sleep Quality, sponsored by San Diego State University. Not yet recruiting. Open to female participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by San Diego State University · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 74 is close to the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
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.
Other: Hass Avocado
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.
Other: Safflower Oil
One medium Hass avocado (150 g pulp) consumed once daily for 8 weeks.
A 27-g portion of safflower oil consumed once daily for 8 weeks.
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
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
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Plan to share: Undecided
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