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CTRI Number  CTRI/2023/02/049727 [Registered on: 15/02/2023] Trial Registered Prospectively
Last Modified On: 18/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutritional Intervention]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of Almond Consumption on Quality of Sleep in Adults: A Randomised Controlled Trial. 
Scientific Title of Study   Effects of Almond Consumption on Quality of Sleep in Adults: A Randomised Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharvari Desai  
Designation  Post Doc Fellow 
Affiliation  Kasturba Health Society Medical Research Centre 
Address  Kasturba Health Society Medical Research Centre 17, Khandubai Desai road, Jain Stanakwasi Aradhanadham, Vile Parle West, Mumbai
17, Khandubai Desai road, Jain Stanakwasi Aradhanadham, Vile Parle West
Mumbai
MAHARASHTRA
400056
India 
Phone  9833921900  
Fax    
Email  sharvarimalshe8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumik Kalita 
Designation  Consultant Physician 
Affiliation  Famphy 
Address  A 12 502 Tulip Violet Sec 69
A 12 502 Tulip Violet Sec 69
Gurgaon
HARYANA
122101
India 
Phone  9871455291  
Fax    
Email  soumik.kalita@famphy.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumik Kalita 
Designation  Consultant Physician  
Affiliation  Famphy 
Address  A 12 502 Tulip Violet Sec 69
A 12 502 Tulip Violet Sec 69
Gurgaon
HARYANA
122101
India 
Phone  9871455291  
Fax    
Email  soumik.kalita@famphy.com  
 
Source of Monetary or Material Support  
Almond Board of California Modesto 1150 Ninth Street Ste 1500, CA  95354 USA 
 
Primary Sponsor  
Name  Almond Board of California 
Address  California USA 
Type of Sponsor  Other [Research Organisation under USDA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharvari Desai   Kasturba Health Society   Kasturba Health Society Medical Research Centre 17, Khandubai Desai road, Jain Stanakwasi Aradhanadham, Vile Parle West, Mumbai 17, Khandubai Desai road, Jain Stanakwasi Aradhanadham, Vile Parle West Mumbai MAHARASHTRA 400056
Mumbai
MAHARASHTRA 		 9833921900

sharvarimalshe8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INTERSYSTEM BIOMEDICA ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PSQI score above 5 or ESS score equal to or above 10 upon screening. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Almonds  60 grams of whole raw almonds in divided doses everyday for 6 months 
Comparator Agent  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  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  PSQI score above 5 or ESS score equal to or above 10 upon screening.
Stable sleep habits for last 6 months (Self-reported)
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sleep efficiency   Baseline and Endpoint 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 		 Baseline and Endpoint
I.e Baseline and 8 weeks 
 
Target Sample Size   Total Sample Size="208"
Sample Size from India="208" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The circadian rhythm drives the architectural markers of sleep which includes its stages, timings, duration of sleep, sleep latency, sleep derailment and disruption. Our previous studies have observed that about 38.7% of school going children experience disturbed sleep where more than 50 % children slept for less than 7 hours per day. (22) Also, insufficient sleep was observed to be a common occurrence in those with metabolic syndrome particularly PCOS with almost 57.9% sleeping less than 7 hours a day. (23) Therefore, this unrecognized public health problem i.e. sleep deprivation and poor quality of sleep is of concern and needs to be addressed before it becomes an epidemic. Thus, this study builds upon the findings of our previous study which reported a favourable influences of daily almond consumption on insulin resistance, dyslipidaemia, and inflammation in young adults in India (24) and we hypothesize that almonds which contain melatonin can be useful to improve sleep health.

Sleep plays a key role in maintaining cellular homeostasis, energy conservation, metabolic waste clearance, and regulating immune functions. (25) Tryptophan is a unique precursor for biosynthesis of serotonin and melatonin both of which play key regulating roles on the sleep-wake cycle. It is catabolised via 2 distinct biochemical pathways: (1) the serotonin pathway (5%) and (2) the kynurenine pathway (KP) (majority, 95%). Sleep is important for maintaining inflammatory homeostatic functions and its loss is linked to the alterations in the immune response.
Chronic sleep curtailment induces significant stress on pancreatic tissues which promotes the development of type 2 diabetes. (26) Sleep loss reduces insulin sensitivity in healthy adults and accelerated formation of advanced glycation end products (AGEs). AGEs lead to marked and sustained production of proinflammatory mediators, besides having a direct effect on proteins and lipids. (27, 28). Further, Brain-derived neurotrophic factor (BDNF) which belongs to the neurotrophin family, are connected to various physiological functions in the brain particularly relevant in neuroplasticity, memory and sleep (29, 30).

Many studies have tried to characterize the functional bioactive compounds in vegetables and derived foodstuffs, particularly those that increase their antioxidant activity, such as melatonin. This molecule is widespread among living organisms and is involved in many physiological processes, including circadian rhythms, hormonal regulation, temperature, mood and immune system responses.(31) Due to its pharmacological properties and its use as a chronobiotic, melatonin has been proposed to alleviate the disruption of circadian rhythms, as occurs in jet lag and insomnia.(32) Moreover, melatonin is an amphipathic molecule that is able to cross cell membranes and the blood–brain barrier and possesses intrinsic and powerful antioxidant activity that is effective in scavenging free radical oxygen and nitrogen species.(33) Consequently, melatonin exhibits anticancer,(34) anti-inflammatory(35) and neuroprotective effects.(36) Additionally, it has also been proposed to control chronic diseases such as diabetes, cardiovascular diseases and obesity.(37)

Almonds contain melatonin and the high contents of phenolic compounds in almonds may be attributed to the antioxidant activities. Nut consumption has been clearly linked to beneficial effects on health. The composition of almonds makes them a suitable for inclusion in diet regimes used for improvement of metabolic health. (38) Almonds reduced non-HDL-C, LDL-C, apoB, TC/HDL ratio, LDL/HDL ratio, and apoB/apoA1 ratio and central adiposity, all important risk factors for cardio metabolic dysfunction, and HDL-C concentrations. (39) Intake of sweet almond had a significant impact on reducing insomnia and improving sleep quality. (40) Almond is considered anti-inflammatory foods, which contain magnesium, L-arginine, MUFAs, PUFAs, antioxidants and dietary fibers. (41)

Therefore, the proposed randomized controlled trial would determine the potential benefit of almond consumption on sleep quality, its effect on associated biomarkers as well as quality of life. Thus, there is a felt need to conduct research in this area and possibly contribute in terms of a food-based intervention.

  

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