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Clinical Trials/NCT05953324
NCT05953324CompletedNot Applicable

The Effects Of Kiwifruit Consumption On Sleep Quality, Fatigue And BMI In Saudi Students With Poor Sleep Quality: A 6-Week Pilot Randomized Controlled Trial

Umm Al-Qura University2 sites in 1 country26 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
Body mass index

Study Overview

Brief Summary

Hypothesis: Kiwifruit contains antioxidants and serotonin which may be beneficial in the treatment of sleep disruption. Aim: to assess the effects of daily intake of kiwifruit on sleep quality, fatigue, and BMI among Saudi adults with poor sleep quality. Methods: Twenty-six female participants (14 cases, and 12 controls) were included. All participants were aged ≥18 years and were Saudi and had poor sleep quality. Pregnant, lactating and participants with any chronic diseases such as cardiovascular or neurological diseases, and history of using herbal or medications for inducing sleep for the last two months were excluded. Participants in the case group consumed 2 kiwifruits 1 hour before bedtime nightly for 6 weeks and the control group did not consume kiwifruit. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to assess sleep quality before and after kiwi consumption (score ≥ 5 indicates poor sleep quality), Fatigue Severity Scale (FSS) was used to assess fatigue and anthropometrics were measured based on the WHO guidelines. After 6 weeks, sleep quality, fatigue and BMI were compared between cases and controls. Kiwifruit consumption may improve sleep quality in adults with self-reported poor sleep quality. Further investigation of the sleep promoting properties of kiwifruit is required.

Detailed Description

Introduction People spend almost one third of their lives in sleep and it is one of the main contributors to our life and wellbeing. Sleep quality has several components including sleep duration, timing, efficiency (time in bed spent asleep) and latency (the amount of time it takes to fall asleep). Sleep disruption may be defined as any change in the components of sleep quality. A cross-country comparative analysis reported the economic cost of insufficient sleep from 62,000 people in UK, US, Canada, Germany, and Japan. Insufficient sleep costs $411 billion annually for the US, $138 billion for Japan, £40 billion for UK, $60 billion for Germany, and $21 billion for Canada. No study has measured the economic cost of sleep disruption in Saudi Arabia. This may be due to the fact that sleep medicine is relatively a new specialty in the medical community.

The National Sleep Foundation recommends different sleep durations for individuals according to age. Adults aged between 18-64 years are recommended to sleep 7-9 h/day. In Saudi Arabia, 33.8% of adults sleep less than 7 hours, and this was shown in women more than men. In meta-analyses, short sleep duration has been associated with an increased risk of obesity. Sleep disruption has been shown to increase the risk of cancer, type 2 diabetes mellitus, cardiovascular disease and coronary heart disease. Furthermore, sleep disruption has been associated with an increased risk of mortality. Collectively, sleep disruption has detrimental economic and health consequences and identifying the factors that may improve it is a public health priority. Thus, using interventions to improve sleep quality may help reduce disease risk and occurrence.

Nutritional research studied the effects of micro and macronutrients and whole foods on sleep measures. Micronutrients studied in relation to sleep included tryptophan, zinc, B-vitamins and polyphenols. A recent systematic review explored the effects of macronutrient manipulation on sleep outcomes. Manipulating carbohydrate intake appeared to alter sleep outcomes in healthy individuals. Several food items were studied in relation to sleep outcomes including fish tart cherry juice and products and kiwi fruit. Despite these studies, nutritional advice that can be recommended for sleep hygiene is inconclusive due to limited interventional studies.

Recently, kiwifruit has gained interest in regards to sleep outcomes. This may be due to the potential mechanisms of kiwifruit on sleep. Kiwifruit contain melatonin which is important for regulating the circadian rhythms and sleep cycles. Another potential mechanism is the high content of polyphenols, antioxidants, flavonoids, carotenoids, and anthocyanins that may decrease oxidative stress in people with sleep disorders or poor sleep quality. Furthermore, polyphenols may influence sleep through their effects on circadian rhythms, clock gene expression, and peripheral clocks. Kiwifruits contain a protein named actinidin which is involved in precursors of neurochemicals required for sleep-wake regulation. In addition, kiwifruit is rich in folate and vitamin c which are essential in the metabolism of amino acids into neurochemicals. Regardless of the potential mechanisms of kiwifruit on sleep, only two interventional studies were conducted to explore this relationship. However, one study did not include a control group and the intervention period in another study was only 4 weeks.

Therefore, investigators designed the study with the purpose of replicating the study with a control group and a longer intervention period to investigate whether kiwi has beneficial properties on sleep. Investigators conducted a randomized, controlled trial addressing whether intake of kiwifruit would improve sleep parameters in a Saudi student population with poor sleep quality.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • aged ≥ 18 years
  • have poor sleep quality that was assessed in the screening visit by the PSQI (a score of at least 5)

Exclusion Criteria

  • lactating
  • participants with any chronic diseases such as cardiovascular or neurological diseases
  • has a history of using herbal or medications for inducing sleep for the last two months

Outcomes

Primary Outcomes

Body mass index

Time Frame: post intervention at week 6

Participants' weight and height were measured via (GIMA Pegaso Digital Scale), body mass index categories based on WHO

sleep quality

Time Frame: post intervention at week 6

The Pittsburgh Sleep Quality Index questionnaire, minimum value is 0 and maximum value is 21. A value higher than 5 indicates poor sleep quality

Fatigue

Time Frame: post intervention at week 6

Fatigue Severity Scale. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreements, and the final score represents the mean value of the 9 items. Higher scores indicate more fatigue.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Essra Noorwali

Assistant Professor

Umm Al-Qura University

Study Sites (2)

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