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

NCT05953324 | Completed

• 1 other identifier: HAPO-02-K-012-2021-11-866
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Fatigue; Body Weight

Keywords

Sleep; Fatigue; Body mass index; kiwifruit; Saudi Arabia; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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

  post intervention at week 6

• 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.

  post intervention at week 6

• Body mass index

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

  post intervention at week 6

Study Arms (2)

Cases

EXPERIMENTAL

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.

Other: Kiwifruit

Controls

NO INTERVENTION

Had poor sleep quality however did not consume kiwifruit

Interventions

Kiwifruit OTHER

2 kiwifruit for 6 weeks

Cases

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, 21955, Saudi Arabia

Location

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Related Links

• WHO: A healthy lifestyle - WHO recommendations

MeSH Terms

Conditions

Parasomnias; Fatigue; Body Weight

Interventions

alcohol acyltransferase, Actinidia

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Essra Noorwali, PhD

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 20, 2023
• Study Start: January 1, 2022
• Primary Completion: January 31, 2022
• Study Completion: April 30, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)