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AzTrials

Sleep DisturbanceNCT05953324

The Effects Of Kiwifruit Consumption On Sleep Quality, Fatigue And BMI Of Saudi Adults

A study testing Kiwifruit in people with Sleep Disturbance and Fatigue, run by Umm Al-Qura University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance, Fatigue, Body Weight
What is being tested?
Kiwifruit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSaudi Arabia
Study dates
1 Jan 2022to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Pregnant
  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Umm Al-Qura University

    Mecca, 21955

Other trials in Saudi Arabia

About this study

Official title: 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

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.

Read the 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.

This study aims to 1) compare between sleep, fatigue and BMI in cases and controls at the start of the study and after 6 weeks in Saudi adults 2) Study the effects of kiwifruit consumption on sleep quality, fatigue, and BMI in Saudi adults.

Study Hypothesis: Kiwifruit intake may improve sleep quality, fatigue and decrease BMI

Materials and methods Study design: a pilot randomized controlled trial

Participants: The study included university students aged ≥ 18 years with poor sleep quality from Umm Al-Qura University, Makkah, Saudi Arabia. Ethical approval was obtained from the Biomedical Research Ethics Committee at Umm Al-Qura University. No. HAPO-02-K-012. This study was carried out in accordance with the principles of the Helsinki Declaration. Participants were recruited through email and several social media platforms including WhatsApp™ and Twitter™ by a flyer between January-February 2022. Participants were invited to a screening visit (30-45 minutes) at Umm Al-Qura University Nutrition clinic to assess eligibility. In the screening visit, researchers explained the study aims and provided participants with a consent form and a kiwifruit consumption diary if eligible.

Recruitment status: Completed

Questionnaires:

A questionnaire was created to be filled in by the participants in both visits. The questionnaire included a brief introduction and a consent statement "I agree to participate in this study. Before finishing the trial, I can freely and without consequences terminate my participation". In addition, it included demographic questions, sleep quality questionnaire (PSQI) and the Fatigue Severity Scale (FSS).

Sleep quality Sleep quality was assessed using the validated Pittsburgh Sleep Quality Index (PSQI), which is an 18-item questionnaire. Two language versions of the PSQI were used; English, and the Arabic version that was translated by 10 Arabic bilingual translators was used. The PSQI is a subjective measure that assesses seven factors of sleep: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21. Higher scores indicate lower sleep quality. A global PSQI score higher than 5 points indicates poor sleep quality. Moreover, to analyze variables not considered by the PSQI, investigators included in the survey questions of stability of participants usual sleep/wake patterns and if they differ on weekends and how often they had naps.

The Fatigue Severity Scale (FSS) Fatigue was assessed using the Fatigue Severity Scale (FSS) which is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. 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. The researchers independently translated the original version of the questionnaire from English to Arabic. Prior to use in this study, the questionnaire was initially administered to 10 bilingual subjects, who completed both the Arabic version and the English version to determine the test-retest reliability. Fatigue was independent of the version.

Study intervention Eligible participants were randomly assigned to either a non-kiwifruit feeding group (controls) or consumed two medium-size kiwifruit group [21] (cases) 1 hour before bedtime every night for 6 weeks (42 days in total). Randomization was performed by giving participants a note identifying the condition to which they were randomized; the note was placed in a sealed envelope. Blindness was not applicable since cases received kiwifruit and controls did not receive. Total number of kiwis consumed should be (14 kiwis (number of kiwis in one week) x 6 (number of weeks) = 84 kiwis in total. Participants consuming the kiwifruit were asked to keep a diary to record if they consumed them every day. During the 6-week intervention period, participants received their kiwifruit every week on the first day of the week (Sunday) that is adequate for a week (14 kiwi fruits brand name: Sharbatly Co. Ltd, variety: Hayward, country of origin: Italy). The kiwifruits were supplied at optimum ripeness for consumption and were instructed to keep the kiwi in the fridge to prevent damage.

Anthropometric measurements Participants' weight and height were measured via (GIMA Pegaso Digital Scale) on both visits to calculate their body mass index (BMI). WHO guidelines were used to take physical measurements of participants and BMI categorization was based on WHO.

Statistical Analysis Data analysis was performed using Statistical Package for the Social Sciences, SPSS 23rd version. Frequency and percentages were used to display categorical variables. Mean and standard deviation were used to present numerical variables. The Shapiro-Wilk test was used to test normality. Independent t-test and paired t-test were used to test associations for normally distributed variables (age, duration of nap, BMI at both start and end of the study, fatigue score at both start and end of the study, PSQI at end of the study). While the Mann-Whitney U test and Wilcoxon Signed-Rank test were used for non-normally distributed variables (PSQI at start of the study). Pearson's correlation was also used to test for associations between numerical variables. The level of significance was set at 0.05.

Being tested
Kiwifruit
Keywords
Sleep, Fatigue, Body mass index, kiwifruit, Saudi Arabia, Randomized controlled trial
Medical subject headings
Parasomnias, Fatigue, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KiwifruitOther

    2 kiwifruit for 6 weeks

Study groups in NCT05953324
Study groupRoleWhat they receive
CasesExperimentalconsumed two medium-size kiwifruit group [21] (cases) 1 hour before bedtime every night for 6 weeks (42 days in total).Randomization was performed by giving participants a note identifying the condition to which they were randomized; the note was placed in a sealed envelope. Blindness was not applicable since cases received kiwifruit and controls did not receive. Total number of kiwis consumed should be (14 kiwis (number of kiwis in one week) x 6 (number of weeks) = 84 kiwis in total. Participants consuming the kiwifruit were asked to keep a diary to record if they consumed them every day. During the 6-week intervention period, participants received their kiwifruit every week on the first day of the week (Sunday) that is adequate for a week (14 kiwi fruits brand name: Sharbatly Co. Ltd, variety: Hayward, country of origin: Italy). The kiwifruits were supplied at optimum ripeness for consumption and were instructed to keep the kiwi in the fridge to prevent damage.
Receives: Other: Kiwifruit
ControlsNo interventionHad poor sleep quality however did not consume kiwifruit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sleep quality

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

    Measured: post intervention at week 6

  2. Fatigue

    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.

    Measured: post intervention at week 6

  3. Body mass index

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

    Measured: post intervention at week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start1 Jan 2022
  3. Primary completion31 Jan 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants were randomly assigned to either a non-kiwifruit feeding group (controls) or consumed two medium-size kiwifruit group \[21\] (cases) 1 hour before bedtime every night for 6 weeks (42 days in total). Total number of kiwis consumed should be (14 kiwis (number of kiwis in one week) x 6 (number of weeks) = 84 kiwis in total. Participants consuming the kiwifruit were asked to keep a diary to record if they consumed them every day. During the 6-week intervention period, participants received their kiwifruit every week on the first day of the week (Sunday) that is adequate for a week (14 kiwi fruits brand name: Sharbatly Co. Ltd, variety: Hayward, country of origin: Italy). The kiwifruits were supplied at optimum ripeness for consumption and were instructed to keep the kiwi in the fridge to prevent damage.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05953324
Sponsor's protocol ID
HAPO-02-K-012-2021-11-866
Status last verified
Jul 2023
First submitted
1 Jul 2023
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The following may be shared: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Publications

  • Noorwali E, Hardie L, Cade J. Bridging the Reciprocal Gap between Sleep and Fruit and Vegetable Consumption: A Review of the Evidence, Potential Mechanisms, Implications, and Directions for Future Work. Nutrients. 2019 Jun 19;11(6):1382. doi: 10.3390/nu11061382.

    PubMed 31248175
  • Hafner M, Stepanek M, Taylor J, Troxel WM, van Stolk C. Why Sleep Matters-The Economic Costs of Insufficient Sleep: A Cross-Country Comparative Analysis. Rand Health Q. 2017 Jan 1;6(4):11. eCollection 2017 Jan.

    PubMed 28983434
  • Bahammam AS. Sleep medicine in Saudi Arabia: Current problems and future challenges. Ann Thorac Med. 2011 Jan;6(1):3-10. doi: 10.4103/1817-1737.74269.

    PubMed 21264164
  • Hirshkowitz M, Whiton K, Albert SM, Alessi C, Bruni O, DonCarlos L, Hazen N, Herman J, Katz ES, Kheirandish-Gozal L, Neubauer DN, O'Donnell AE, Ohayon M, Peever J, Rawding R, Sachdeva RC, Setters B, Vitiello MV, Ware JC, Adams Hillard PJ. National Sleep Foundation's sleep time duration recommendations: methodology and results summary. Sleep Health. 2015 Mar;1(1):40-43. doi: 10.1016/j.sleh.2014.12.010. Epub 2015 Jan 8.

    PubMed 29073412
  • Ahmed AE, Al-Jahdali F, AlALwan A, Abuabat F, Bin Salih SA, Al-Harbi A, Baharoon S, Khan M, Ali YZ, Al-Jahdali H. Prevalence of sleep duration among Saudi adults. Saudi Med J. 2017 Mar;38(3):276-283. doi: 10.15537/smj.2017.3.17101.

    PubMed 28251223
  • Itani O, Jike M, Watanabe N, Kaneita Y. Short sleep duration and health outcomes: a systematic review, meta-analysis, and meta-regression. Sleep Med. 2017 Apr;32:246-256. doi: 10.1016/j.sleep.2016.08.006. Epub 2016 Aug 26.

    PubMed 27743803
  • Bacaro V, Ballesio A, Cerolini S, Vacca M, Poggiogalle E, Donini LM, Lucidi F, Lombardo C. Sleep duration and obesity in adulthood: An updated systematic review and meta-analysis. Obes Res Clin Pract. 2020 Jul-Aug;14(4):301-309. doi: 10.1016/j.orcp.2020.03.004. Epub 2020 Jun 8.

    PubMed 32527625
  • Ma QQ, Yao Q, Lin L, Chen GC, Yu JB. Sleep duration and total cancer mortality: a meta-analysis of prospective studies. Sleep Med. 2016 Nov-Dec;27-28:39-44. doi: 10.1016/j.sleep.2016.06.036. Epub 2016 Nov 1.

    PubMed 27938917
  • Erren TC, Morfeld P, Foster RG, Reiter RJ, Gross JV, Westermann IK. Sleep and cancer: Synthesis of experimental data and meta-analyses of cancer incidence among some 1,500,000 study individuals in 13 countries. Chronobiol Int. 2016;33(4):325-50. doi: 10.3109/07420528.2016.1149486. Epub 2016 Mar 22.

    PubMed 27003385
  • Kwok CS, Kontopantelis E, Kuligowski G, Gray M, Muhyaldeen A, Gale CP, Peat GM, Cleator J, Chew-Graham C, Loke YK, Mamas MA. Self-Reported Sleep Duration and Quality and Cardiovascular Disease and Mortality: A Dose-Response Meta-Analysis. J Am Heart Assoc. 2018 Aug 7;7(15):e008552. doi: 10.1161/JAHA.118.008552.

    PubMed 30371228
  • da Silva AA, de Mello RG, Schaan CW, Fuchs FD, Redline S, Fuchs SC. Sleep duration and mortality in the elderly: a systematic review with meta-analysis. BMJ Open. 2016 Feb 17;6(2):e008119. doi: 10.1136/bmjopen-2015-008119.

    PubMed 26888725
  • Liu TZ, Xu C, Rota M, Cai H, Zhang C, Shi MJ, Yuan RX, Weng H, Meng XY, Kwong JS, Sun X. Sleep duration and risk of all-cause mortality: A flexible, non-linear, meta-regression of 40 prospective cohort studies. Sleep Med Rev. 2017 Apr;32:28-36. doi: 10.1016/j.smrv.2016.02.005. Epub 2016 Mar 3.

    PubMed 27067616
  • Binks H, E Vincent G, Gupta C, Irwin C, Khalesi S. Effects of Diet on Sleep: A Narrative Review. Nutrients. 2020 Mar 27;12(4):936. doi: 10.3390/nu12040936.

    PubMed 32230944
  • Du C, Almotawa J, Feldpausch CE, Folk SYL, Parag H, Tucker RM. Effects of macronutrient intake on sleep duration and quality: A systematic review. Nutr Diet. 2022 Feb;79(1):59-75. doi: 10.1111/1747-0080.12671. Epub 2021 Apr 19.

    PubMed 33876534
  • Hansen AL, Dahl L, Olson G, Thornton D, Graff IE, Froyland L, Thayer JF, Pallesen S. Fish consumption, sleep, daily functioning, and heart rate variability. J Clin Sleep Med. 2014 May 15;10(5):567-75. doi: 10.5664/jcsm.3714.

    PubMed 24812543

Questions about this trial

What is this clinical trial studying?

A study testing Kiwifruit in people with Sleep Disturbance and Fatigue, run by Umm Al-Qura University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep quality (time frame: post intervention at week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05953324, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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