Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000194662
Ethics application status
Approved
Date submitted
28/10/2022
Date registered
23/02/2023
Date last updated
23/02/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST) Study: An Australian partner study conducted in male twins
Scientific title
Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST) Study: An Australian partner study conducted in male twins
Secondary ID [1] 308292 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FEASST study: Australia
Linked study record
This trial is a partner study of NCT05368194. and will be conducted in a cohort of Australian living twins. The data will be pooled for comparison after the completion of both studies.

Health condition
Health condition(s) or problem(s) studied:
obesity 328076 0
Depression 328077 0
anxiety 328110 0
subfertility 328111 0
Condition category
Condition code
Diet and Nutrition 325136 325136 0 0
Obesity
Mental Health 325137 325137 0 0
Anxiety
Mental Health 325165 325165 0 0
Depression
Reproductive Health and Childbirth 325166 325166 0 0
Fertility including in vitro fertilisation
Reproductive Health and Childbirth 325167 325167 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention treatment will be categorised as diet B. The diet treatment will be delivered to the participants house. The intervention lasts for 3 weeks and the participant should consume only what is given to them for these 3 weeks, with the exception of coffee, water, tea and some milk.
This treatment consists of mainly processed foods. The macronutrient composition will equivalent to Diet A which is 49% carbohydrates, 16% protein and 35% fat. However, the carbohydrates will be derived mainly from refined grains and added sugar. The fats will be derived mainly from processed dairy foods. Protein will be derived mainly from processed meals. The meals will consist mainly of dairy, refined carbohydrates, red meat and other processed meats. An example meal is a pulled pork burger, served on a brioche bun with caramelised onions and BBQ sauce, with potato chips. Most meals will be fully pre-prepared, labelled and ready to eat (after defrosting and warming). However, some food will require preparation for example adding cheese and sandwich meat to sandwich bread.
A food diary will be given to participants with instructions on what food to eat on what day, and how to prepare each meal.
The diet has already been created by a registered nutritionist, and appropriate meal sizes will be given to participants based on weight, height, age and activity levels calculated by members of the study team. If any issues arise with hunger, the study team will revise the meal sizes and ensure more food is delivered.
Compliance will be assessed via survey at the end of the 3-week intervention, and daily surveys will be completed to monitor the participant and assist in keeping them on track.
Fitbits will be given to participants to wear for the 3-week intervention to monitor physical activity levels.
Participants will need to come into the clinic located at Monash Medical Centre (Clayton) to provide blood, saliva and semen before and after the intervention.
Intervention code [1] 324747 0
Prevention
Intervention code [2] 325023 0
Lifestyle
Comparator / control treatment
As we are recruiting male twins, each twin within a pair will act as the others twin control (co-twin control design). One twin will receive the control diet and the other twin will receive the comparator treatment below.
Participants in one group will receive control treatment (Diet A). The diet treatment will be delivered to the participants house. The diet period is 3 weeks and the participant should consume only what is given to them for these 3 weeks, with the exception of coffee, water, tea and some milk.
The control treatment consists of mainly unprocessed foods. The macronutrient composition will be 49% carbohydrates, 16% protein and 35% fat. The carbohydrates will be derived mainly from fruits and wholegrain. The fats will be derived from nuts, eggs, and other foods high in healthy fats. Protein will be derived mainly from chicken, fish and legumes. The meals will consist of vegetables, fruits and wholegrains. An example meal is a salmon salad, consisting of a baked salmon fillet with some additional smoked salmon, served with a quinoa, spinach and potato salad. Most meals will be fully pre-prepared, labelled and ready to eat (after defrosting and warming). However, some food will require preparation for example boiling eggs or making a porridge with the ingredients already given.
A food diary will be given to participants with instructions on what food to eat on what day, and how to prepare each meal.
The diet has already been created by a registered nutritionist, and appropriate meal sizes will be given to participants based on weight, height, age and activity levels calculated by members of the study team. Both diets are isocaloric, and there should not be a calorie deficit of any sort. If any issues arise with hunger, the study team will revise the meal sizes and ensure more food is delivered.
Compliance will be assessed via survey, and daily surveys will be completed to monitor the participant.
Fitbits will be given to participants to wear to monitor physical activity levels.
Participants will need to come into the clinic located at Monash Medical Centre (Clayton) to provide blood, saliva and semen.
Control group
Active

Outcomes
Primary outcome [1] 332961 0
Changes in sperm DNA methylation will be assessed using reduced representation bisulphite sequencing (RRBS).
Timepoint [1] 332961 0
At baseline and 3 weeks post intervention commencement
Primary outcome [2] 332962 0
changes to sperm small noncoding RNA content will be assessed using small RNA sequencing technology
Timepoint [2] 332962 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [1] 415331 0
Changes to sperm motility assessed using microscope and conducting a basic semen analysis as per the WHO guidelines
Timepoint [1] 415331 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [2] 415332 0
Changes to mental health, addressed using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 415332 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [3] 415439 0
changes to sperm concentration assessed using microscope and conducting a basic semen analysis as per the WHO guidelines
Timepoint [3] 415439 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [4] 415440 0
Changes to semen volume assessed using microscope and conducting a basic semen analysis as per the WHO guidelines
Timepoint [4] 415440 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [5] 415441 0
Changes to mental health, addressed using the Perceived Stress Scale (PSS)
Timepoint [5] 415441 0
At baseline and 3 weeks post intervention commencement
Secondary outcome [6] 418700 0
Experiences of adversity in childhood, addressed using the adverse childhood experiences questionnaire
Timepoint [6] 418700 0
This data will be collected at baseline only as the data should not change over the 3 week intervention

Eligibility
Key inclusion criteria
Male monozygotic twin
Male dizygotic twin
Age 18-45 years old
No disease of the reproductive system
Non-smoker
Normal semen parameters (volume, concentration, motility) according to WHO's criteria for semen quality
Healthy weight range (BMI 18.5-30)
Fluent in English
Normal liver and renal function
Minimum age
20 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self-reported history of serious or chronic illness
Self-reported history of obesity
History of food restrictions, allergies, and/or disordered eating
Currently actively trying to conceive a child
Diagnosis of infertility or disease of the reproductive system
Evidence of dysregulated metabolism, characterized by the occurrence of any one of the following:
o Waist circumference >102 cm
o Blood pressure > 130/85 mm Hg

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures: coin-tossing. Will identify heads as diet A and tails as diet B and flip the coin for the first twin in the list. The other twin will automatically be allocated to the other group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We have estimated the required number of participants for the study based on simulation results from a previous study exploring CpG methylation significance in disease-discordant twin pairs. From these studies, it was determined that a sample size of 25 twin pairs (50 individuals) has a power of over 80% and a level of significance of 0.05 for the parameter of DNA methylation to detect a mean difference of 8% in methylation, wherein said methylation change is considered a significant difference in methylation percentage. Therefore, to secure enrolment of the estimated number of participants, we will include a minimum of 25 men in each study treatment group for a total of 50 participants.

Level of Significance
We will use a significance level of p = 0.05 and the p-values will be adjusted for multiple comparisons by calculating false discovery rate (FDR).

Pooling of results
Results will be pooled with the partner study conducted in Denmark in a non-twin population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
23/10/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 23467 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 38872 0
3168 - Clayton
Recruitment postcode(s) [2] 38873 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 312543 0
Charities/Societies/Foundations
Name [1] 312543 0
Novo Nordisk Foundation (Challenge Grant)
Country [1] 312543 0
Denmark
Funding source category [2] 312544 0
University
Name [2] 312544 0
Deakin University (IMPACT SEED grant)
Country [2] 312544 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Novo Nordisk Foundation
Address
Novo Nordisk Foundation Novo Nordisk A/S Novo Allé 1, 2880 Bagsvaerd Denmark
Country
Denmark
Secondary sponsor category [1] 314141 0
University
Name [1] 314141 0
Deakin University
Address [1] 314141 0
75 Pigdons Rd, Waurn Ponds VIC 3216
Country [1] 314141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311871 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311871 0
Ethics committee country [1] 311871 0
Australia
Date submitted for ethics approval [1] 311871 0
05/08/2022
Approval date [1] 311871 0
26/08/2022
Ethics approval number [1] 311871 0
RES-22-0000-051A

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

Contacts
Principal investigator
Name 122670 0
Prof Jeffrey Craig
Address 122670 0
Room KA4.328, The Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Faculty of Health, Deakin University, Geelong Waurn Ponds Campus, Locked Bag 2000, Geelong, VIC 3220 (Wadawurrung Country)
Country 122670 0
Australia
Phone 122670 0
+61 409517900
Fax 122670 0
Email 122670 0
[email protected]
Contact person for public queries
Name 122671 0
Victoria George
Address 122671 0
Room KA4.328, The Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Faculty of Health, Deakin University, Geelong Waurn Ponds Campus, Locked Bag 2000, Geelong, VIC 3220
Country 122671 0
Australia
Phone 122671 0
+61 432188523
Fax 122671 0
Email 122671 0
[email protected]
Contact person for scientific queries
Name 122672 0
Victoria George
Address 122672 0
Room KA4.328, The Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Faculty of Health, Deakin University, Geelong Waurn Ponds Campus, Locked Bag 2000, Geelong, VIC 3220
Country 122672 0
Australia
Phone 122672 0
+61 432188523
Fax 122672 0
Email 122672 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
All data will be pooled and analysed together to increase power. No data will be published on an individual participant.


What supporting documents are/will be available?




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.