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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: 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 are locally popular, highly accepted among the adult population living in urban settings for 6 months CONDITION: PRIMARY OUTCOME: Sleep efficiencyTimepoint: Baseline and Endpoint SECONDARY OUTCOME: 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 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)
Epistemonikos ID: eef9ea4906c9986f9072188f644299f2c015ab5c
First added on: Feb 20, 2024