Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000046808
Ethics application status
Approved
Date submitted
29/09/2020
Date registered
18/01/2021
Date last updated
18/01/2021
Date data sharing statement initially provided
18/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effect of kiwifruit on sleep quality, mood and metabolites associated with sleep in young healthy men
Scientific title
Sleep quality and urinary metabolite levels of melatonin, serotonin and water soluble vitamins following evening intake of fresh, dried green kiwifruit and control in healthy adult males
Secondary ID [1] 302166 0
None
Universal Trial Number (UTN)
U1111-1257-5872
Trial acronym
Kiwi Sleep MEMO - acute study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 318818 0
Mood state 318819 0
Condition category
Condition code
Mental Health 316831 316831 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 317481 317481 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume, in randomised, single-blind fashion (cross-over design), three different interventions, i) two fresh green kiwifruit (200g), ii) freeze-dried green kiwifruit powder (32g) (equivalent to two whole kiwifruits) mixed with 170ml water or iii) water 170ml (control). Each participant will receive a single intakes worth of the intervention, and treatments i, ii and iii will occur on separate occasions with a seven day washout period in between.

The study is an in-home study setting. Participants will be provided with a standardised evening meal [Man Size Spaghetti and Meatballs (McCain Foods), ~720 kcal] to consume four hours before their usual bed-time. Following this, they are to consume their allocated intervention. The intervention will be provided by a researcher who is not part of the analysis of the study at the collection of a standardised meal. Before bed-time, participants are to score their sleepiness using the Stanford Sleepiness Scale (SSS). They are then free to sleep. Upon waking the following morning, the whole morning urine sample is to be collected. From this, they are to complete the SSS, Leeds Sleep Evaluation Questionnaire (LSEQ) and a Profile of Mood States (POMS) survey. Participants will be asked to note down time intervention was consumed and will receive a text message reminder to consume intervention. The urine sample and questionnaires are to be delivered to the Institute within two hours.
Intervention code [1] 318466 0
Treatment: Other
Intervention code [2] 318922 0
Lifestyle
Comparator / control treatment
The control will be water with nothing added to it.
Control group
Placebo

Outcomes
Primary outcome [1] 324949 0
Changes in 6-sulfatoxymelatonin in urine
Timepoint [1] 324949 0
First morning void urine samples will be used to quantify 6-sulfatoxymelatonin using ELISA kit. Urine collections are at the following morning of intervention consumption.
Primary outcome [2] 324950 0
Changes in 5-hydroxyindoleacetic acid in urine
Timepoint [2] 324950 0
First morning void urine samples will be used to quantify 5-hydroxyindoleacetic acid using ELISA kit. Urine collections are at the following morning of intervention consumption.
Primary outcome [3] 324951 0
Changes in subjective sleep quality will be assessed using the Stanford Sleepiness Scale and the Leeds Sleep Evaluation Questionnaire and changes in objective sleep quality measurements (sleep onset latency, wake after sleep onset, total sleep time and sleep efficiency) will be measured using wrist-worn actigraphy monitor.
Timepoint [3] 324951 0
This will be measured on each evening an intervention is consumed. The sleep period following the evening intervention is what will be measured.
Secondary outcome [1] 386292 0
Changes in mood will be assessed using the Profile of Mood States (POMS) survey
Timepoint [1] 386292 0
Mood assessment will be conducted every morning after each intervention consumption.
Secondary outcome [2] 386293 0
Changes in urinary levels of water-soluble vitamins (Vitamin C, thiamine; riboflavin and its vitamer FMN; the B3 vitamers: nicotinic acid, nicotinamide and nicotinuric acid, and pantothenic acid; and the B6 vitamers pyridoxal, pyridoxamine, PLP, and 4-pyridoxic acid) using ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS.
Timepoint [2] 386293 0
First-morning void urine samples will be used to quantify water-soluble vitamins mentioned above, Urine collections are at the following morning of intervention consumption.

Eligibility
Key inclusion criteria
Healthy males
Aged between 18-35 years of age
Body mass index (BMI) >18.5 or <30kg/m2
Physically active no more than 2 hours per day
Good sleeper and poor sleepers - Poor sleepers, defined as having Pittsburgh Sleep Quality Index (PSQI) score >5 (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989), good having score <=5
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of specific prescribed medication as listed below or recreational drugs use:
Diuretics, Oral or inhaled steroids, Cholinergic antispasmodics, Lactulose, Metamucil, Antibiotics, Sedative/hypnotic medication, Laxatives, Antacids, Cholesterol-lowering medications, Proton pump inhibitors (acid reflux treatments), Vitamin/mineral supplements, Heparin, Antidepressants
Excessive alcohol intake defined as >20g of pure alcohol (2 drinks)/d on average. (>21 standard drinks a week)
Smoke cigarettes
History of gastrointestinal surgery or gastrointestinal disorders including inflammatory bowel disease (IBD), ulcerative colitis, coeliac disease, Crohn’s disease
Medical conditions (e.g., cardiorespiratory, diabetes mellitus, bleeding disorders)
Psychiatric conditions (e.g., Major depressive disorder, Schizophrenia)
Antibiotic consumption (1 month before the study and during the study)
Significant weight loss during the past six months
Being on a controlled diet or dietary weight loss regimen within four weeks before and during the study
Vegetarian/vegan
Allergies to dairy products, eggs, fruits, cereals or soy
Diagnosed with or symptoms of COVID-19
Shift workers
Participants will be asked to abstain from alcohol, caffeinated beverages and vigorous exercise eight hours before their averaged bedtimes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible volunteers are assigned a subject number and randomised onto a treatment visit schedule based on a Latin square design balanced for the order of presentation and carry-over effect. Treatments will be assigned a code. The treatment code will be held by two scientists who are not responsible for treatment dispensing or data collection. The unblinded scientists are responsible for allocating a random treatment position to the volunteers and preparing the study interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a 6 × 3 Williams design balanced for the order of presentation and carryover effects. Randomisation will be performed using the method of randomly permuted blocks (https://www.randomizer.org/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Treatment effects will be determined with a one-way repeated measures ANOVA. Relations of subjective measures and metabolites will be tested using Pearson's Correlation Coefficient. Statistical significance will be accepted at P < 0.05. All data are presented as means ± SEs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2021
Date of last participant enrolment
Anticipated
29/03/2021
Actual
Date of last data collection
Anticipated
24/05/2021
Actual
Sample size
Target
24
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 22899 0
New Zealand
State/province [1] 22899 0
Palmerston North

Funding & Sponsors
Funding source category [1] 306592 0
Other
Name [1] 306592 0
Riddet Institute
Country [1] 306592 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University Manawatu (Turitea)
Tennent Drive
Palmerston North 4474
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307122 0
None
Name [1] 307122 0
Address [1] 307122 0
Country [1] 307122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306775 0
Massey University Human Ethics
Ethics committee address [1] 306775 0
Ethics committee country [1] 306775 0
New Zealand
Date submitted for ethics approval [1] 306775 0
29/09/2020
Approval date [1] 306775 0
11/12/2020
Ethics approval number [1] 306775 0
SOA 20/52

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104982 0
Mr Alex Kanon
Address 104982 0
Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442
Country 104982 0
New Zealand
Phone 104982 0
+64 6 951 7742
Fax 104982 0
Email 104982 0
[email protected]
Contact person for public queries
Name 104983 0
Sharon Henare
Address 104983 0
School of Health Sciences
College of Health
Massey University
Private Bag 11222
Palmerston North 4442
Country 104983 0
New Zealand
Phone 104983 0
+64 6 3569099 84289
Fax 104983 0
Email 104983 0
[email protected]
Contact person for scientific queries
Name 104984 0
Warren McNabb
Address 104984 0
Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442
Country 104984 0
New Zealand
Phone 104984 0
+64 6 951 7742
Fax 104984 0
Email 104984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.