Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001369213
Ethics application status
Approved
Date submitted
9/08/2018
Date registered
14/08/2018
Date last updated
18/02/2022
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of animal and plant origin diet on sleep health in healthy adults
Scientific title
Effects of omnivore and vegan origin diet on sleep health in healthy adults
Secondary ID [1] 295771 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep 309174 0
Diabetes 309175 0
Hypertension 309176 0
Alertness 309177 0
Memory deficits 309206 0
Condition category
Condition code
Diet and Nutrition 308052 308052 0 0
Other diet and nutrition disorders
Neurological 308080 308080 0 0
Other neurological disorders
Cardiovascular 308081 308081 0 0
Hypertension
Metabolic and Endocrine 308082 308082 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Description of the intervention;
a. Omnivores Diet (OD): diet have the capability to obtain chemical energy and nutrients from materials originating from plant and animal. Often, omnivores also have the ability to incorporate food sources such as algae, fungi, and bacteria into their diet as well.
b. Vegan Diet Adjusted (VDA): A vegan diet adjusted with the same proportion of protein and fat from plant origin as omnivores diet.
2. Duration of the base line period is two weeks and then we can get participants diet intake and sleep measurements before any input change occurs.
3. VDA is the same as OD with the same proportion of nutrients except difference in type of protein, CHO and fat (plant protein and fat vs animal protein and fat).
4. Participants will need to provide their own food and follow certain guidelines.
5. Within a healthy, balanced diet, a man needs around 10,500kJ (2,500kcal) a day and woman, that figure is around 8,400kJ (2,000kcal) a day. These values can vary depending on age, metabolism and levels of physical activity, among other things. these will be the same as the average daily kJ intake recorded during baseline period.
6. We have tried replacing the OD with VDA with similar levels of protein, fat, CHO and energy by weeks of trialling and producing numerous Vegan replacement diets (using Foodworks 9) that match the Omniovore diet in protein, fat, carbohydrate and energy proportions. To facilitate the menial, time-consuming (but important) task, we have now arrived at using a Calculator spreadsheet via a mathematical formulation (acknowledging Pemajayantha Vithanage, Mathematician) to find food combination of vegan foods to match nutrient values of the food people eat. This Calculator works well, with minor adjustments, in addition we use food diaries to record food intake by the participants.

The study is to conduct. crossover longitudinal study of vegan diet vs animal diet using healthy adults(30) The crossover experiment study is designed in order to assess the effects of exposure to different diet regimen, plant origin diet (VDA) vs animal origin diet (OD), with the same proportion of nutrients except difference in type of protein, CHO and fat (plant protein and fat vs animal protein and fat), and the benefits or detriment of human sleep health as measured by sleep patterns and sleep-wake circadian rhythm, and the consequence of sleep outcomes including fasting blood glucose, mood and alertness, and cognitive functioning in working memory.

The OD is participants’ normal mixed diet with meat, poultry, fish, eggs, dairy, vegetables, fruit and beverages. The VDA will be made with reference to the proportional dietary intake of OD. The Foodworks 9 nutrition software will be used to convert daily food intake into the nutritional components (protein, fat, carbohydrate, tryptophan, caffeine, zinc, alcohol, and sugar).
OD during the baseline period will be used to calculate the portion of plant energy, CHO, protein and fat in VDA similar to the portion of animal protein and fat in OD. The serve sizes are taken from Australian dietary guidelines and recommended daily intakes from NHMRC and these sizes also will be used to calculate nutritional components.The experiment will be conducted at participants homes. The participants require to allocate their time only for 8 weeks. Eventhough this is a crossover trial no washout period because the study measure the effects of transition (acute or habitual) from OD to VDA and vice versa on sleep and the effects of exposure (post habitual) to VDA and OD and vice versa on sleep
Intervention code [1] 312098 0
Diagnosis / Prognosis
Comparator / control treatment
Omnivore diet
Control group
Active

Outcomes
Primary outcome [1] 307046 0
Subjective sleep measures ( Sleep efficiency, Total sleep time, Sleep onset latency, Wake after sleep onset.
Timepoint [1] 307046 0
The subjective sleep measurements of total sleep time, sleep onset latency and wake after sleep onset will be measured using participants sleep diary, these measurements will be taken through out the study period of 8 weeks
Secondary outcome [1] 350480 0
Blood glucose levels
Timepoint [1] 350480 0
All measurements will be taken at the start of the experiment. That is at the enrolment, then at week 2(base line), week 4, week 5, week 7 and week 8.

Eligibility
Key inclusion criteria
18 - 70 years and healthy
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with mental illness: depression, bi-polar, schizophrenia, or sleep disorders: insomnia, periodic leg movements, sleep apnoea, narcolepsy, REM sleep behaviour disorder.
Other major medical conditions (cardiovascular and respiratory diseases, anorexia nervosa, bulimia, metabolic syndrome), diabetes, who are on any medication, including herbal and vitamin that affect sleep. Participants who are pregnant or planning to become pregnant within next eight weeks, shift workers, vegans, people who consume =5 standard alcohol drinks on any day will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
PhD candidate unable to complete project due to personal reasons.
Date of first participant enrolment
Anticipated
1/10/2018
Actual
12/03/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
17/09/2019
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
30
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27237 0
2141 - Lidcombe
Recruitment postcode(s) [2] 27238 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 300362 0
University
Name [1] 300362 0
The University of Sydney
Country [1] 300362 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006 AUSTRALIA.
Country
Australia
Secondary sponsor category [1] 299809 0
None
Name [1] 299809 0
Address [1] 299809 0
Country [1] 299809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301174 0
Sydney university Human Research Ethics Committee
Ethics committee address [1] 301174 0
Ethics committee country [1] 301174 0
Australia
Date submitted for ethics approval [1] 301174 0
15/08/2018
Approval date [1] 301174 0
13/10/2018
Ethics approval number [1] 301174 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2953 2953 0 0
/AnzctrAttachments/375760-Mitchel Bones-Participant_Information_V 2-24-05-2018cmc MH.pdf (Participant information/consent)
Attachments [2] 2954 2954 0 0
/AnzctrAttachments/375760-Mitchel Bones - Participant-concent-form-V1-02-05-2018 cmc MH.pdf (Participant information/consent)
Attachments [3] 2955 2955 0 0
/AnzctrAttachments/375760-Mitchel Bones - Recommendedvegetables toreplaceanimalproteinandfat-V1-21-04.2018.pdf (Supplementary information)
Attachments [4] 2956 2956 0 0
/AnzctrAttachments/375760-Mitchel Bones-Participant _Screening_ Questionnaires_v2_ 27 04 2018 MH.pdf (Supplementary information)
Attachments [5] 2957 2957 0 0
/AnzctrAttachments/375760-Mitchel Bones-Sleep-diary-V3_17-05-2018 MH.pdf (Supplementary information)
Attachments [6] 2958 2958 0 0
/AnzctrAttachments/375760-Mitchel Bones 3 Day Food Record Chart_V2-04-06-2018.pdf (Supplementary information)
Attachments [7] 2959 2959 0 0
/AnzctrAttachments/375760-Mitchel Bones-Sample of vegan receipes - Red Lentil-Grilled tofu-peanutbutter soothie.pdf (Supplementary information)
Attachments [8] 2960 2960 0 0
/AnzctrAttachments/375760-Mitchel Bones-Sample Nutrient Calculation - OD vs VDAA Calculate_28_06_2018.pdf (Supplementary information)
Attachments [9] 2961 2961 0 0
/AnzctrAttachments/375760(v08-08-2018-17-20-39)-Clinicaltrialprotocol-v1-07-08-2018.pdf (Protocol)
Attachments [10] 3202 3202 0 0
/AnzctrAttachments/375760-Mitchel Bones Study Protocol-V1-14-08-2018.docx (Protocol)

Contacts
Principal investigator
Name 86098 0
A/Prof Chin-Moi Chow
Address 86098 0
Room K222, Building C42, Faculty of Health Sciences, The University of Sydney, NSW 2006 AUSTRALIA.
Country 86098 0
Australia
Phone 86098 0
+61 2 9351 9332,
Fax 86098 0
Email 86098 0
[email protected]
Contact person for public queries
Name 86099 0
Chin-Moi Chow
Address 86099 0
Room K222, Building C42, Faculty of Health Sciences, The University of Sydney, NSW 2006 AUSTRALIA.
Country 86099 0
Australia
Phone 86099 0
+61 2 9351 9332,
Fax 86099 0
Email 86099 0
[email protected]
Contact person for scientific queries
Name 86100 0
Victoria Flood
Address 86100 0
Professor of Allied Health
Western Sydney Local Health District
Faculty of Health Sciences, The University of Sydney, NSW 2006
Country 86100 0
Australia
Phone 86100 0
T +61 2 9351 9001
Fax 86100 0
Email 86100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical, nutrient and sleep data
When will data be available (start and end dates)?
for the first participants start date is 12/03/2019 and end date 08/07/2019
Available to whom?
Researcher, principal and auxiliary supervisors
Available for what types of analyses?
During each dietary regiment, data on sleep pattern and sleep-wake circadian rhythm with actiography will be collected. Acti-watch (wrist watch) which automatically record sleep wake pattern will be provided to all participants. Secondary measures of fasting blood glucose level, blood pressure, mood and alertness, and working memory will be recorded as covariate for analysis.
How or where can data be obtained?
From the researchers computer, and principal and auxiliary supervisors have password protected access to shared data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3071Ethical approval    375760-(Uploaded-15-07-2019-08-35-05)-Study-related document.pdf
3072Clinical study report    375760-(Uploaded-15-07-2019-08-46-39)-Study-related document.pdf
3073Informed consent form    375760-(Uploaded-16-07-2019-11-05-15)-Study-related document.pdf



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.