Effects of Almond Consumption on Quality of Sleep in Adults: A Randomised Controlled Trial.
- Registration Number
- CTRI/2023/02/049727
- Lead Sponsor
- Almond Board of California
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
PSQI score above 5 or ESS score equal to or above 10 upon screening.
Stable sleep habits for last 6 months (Self-reported)
Pregnant and lactating women.
Individuals allergic to almonds
Those who are suffering from sleep disorders: Chronic insomnia, Severe obstructive sleep apnea [apnea-hypopnea index (AHI) more than 30 episodes per hour], Restless leg syndrome, Parasomnias, Narcolepsy, Central apnea, Chronic fatigue syndrome, Fibromyalgia.
Night shift workers or Shift workers, varying work schedule.
Individuals suffering from/ suffered major depression, eating disorders and anxiety disorders.
Those on medication for sleep problems on a regular basis or taking melatonin supplements or on medication for diabetes.
Individuals with a history of prior diagnosis of stroke, myocardial infarction, interventional cardiology procedures, or other major mental illness or substance abuse as well as a history of cognitive impairment and major neurological disorders.
Advised special diets for the last six months.
Chronic pain conditions and taking sedatives, hypnotics, and painkillers regularly.
Substance abuse/smoking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep efficiencyTimepoint: Baseline and Endpoint
- Secondary Outcome Measures
Name Time Method 1.PSQI Scores <br/ ><br>2.REM latency (determined using a polysomnography <br/ ><br>3.Average sleep duration on a 7-day actigraphy report in a subset <br/ ><br>4.Proportion of time spent in REM sleep (6) which will be determined using a polysomnography <br/ ><br>5.ESS scores (43) which will determine improvement in daytime sleepiness. <br/ ><br>6.Quality of life: Performance on WHO Quality of life questionnaire (WHOQOL-BREF / WHOQOL-100). <br/ ><br>7.Levels of serotonin and melatonin. <br/ ><br>8.Inflammatory markers: TNF- alpha, IL-6 <br/ ><br>9.Neuroimmune regulation: Brain-Derived Neurotrophic Factor (BDNF) <br/ ><br>10.Lipid Profile, Fasting Blood Sugar, Post Prandial Blood Sugar and Hba1c. <br/ ><br>Timepoint: Baseline and Endpoint <br/ ><br>I.e Baseline and 8 weeks