Effects of Almond Consumption on Quality of Sleep in Adults: A Randomised Controlled Trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049727

Enrollment

208

Registered

2023-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Almonds: 60 grams of whole raw almonds in divided doses everyday for 6 months Control Intervention1: Iso-caloric Snack: Millet and/or pulse- based standardized isocaloric snacks that a

Eligibility

Inclusion criteria

Inclusion criteria: PSQI score above 5 or ESS score equal to or above 10 upon screening. Stable sleep habits for last 6 months (Self-reported)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Sleep efficiencyTimepoint: Baseline and Endpoint	—

Secondary

Measure	Time frame
1. PSQI Scores 2. REM latency (determined using a polysomnography 3. Average sleep duration on a 7-day actigraphy report in a subset 4. Proportion of time spent in REM sleep (6) which will be determined using a polysomnography 5. ESS scores (43) which will determine improvement in daytime sleepiness. 6. Quality of life: Performance on WHO Quality of life questionnaire (WHOQOL-BREF / WHOQOL-100). 7. Levels of serotonin and melatonin. 8. Inflammatory markers: TNF- alpha, IL-6 9. Neuroimmune regulation: Brain-Derived Neurotrophic Factor (BDNF) 10. Lipid Profile, Fasting Blood Sugar, Post Prandial Blood Sugar and Hba1c. Timepoint: Baseline and Endpoint I.e Baseline and 8 weeks	—

Measure

Time frame

1. PSQI Scores 2. REM latency (determined using a polysomnography 3. Average sleep duration on a 7-day actigraphy report in a subset 4. Proportion of time spent in REM sleep (6) which will be determined using a polysomnography 5. ESS scores (43) which will determine improvement in daytime sleepiness. 6. Quality of life: Performance on WHO Quality of life questionnaire (WHOQOL-BREF / WHOQOL-100). 7. Levels of serotonin and melatonin. 8. Inflammatory markers: TNF- alpha, IL-6 9. Neuroimmune regulation: Brain-Derived Neurotrophic Factor (BDNF) 10. Lipid Profile, Fasting Blood Sugar, Post Prandial Blood Sugar and Hba1c. Timepoint: Baseline and Endpoint I.e Baseline and 8 weeks

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Countries

India

Contacts

Public ContactDr Soumik Kalita

Famphy

soumik.kalita@famphy.com9871455291

Outcome results