Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001184864
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
3/09/2021
Date last updated
11/08/2024
Date data sharing statement initially provided
3/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diet for Dads Sperm: The effect of a dietary intervention on sperm function in men with obesity.
Scientific title
The effect of a dietary intervention on sperm function in men who are obese with a sub optimal low-nutrient diet,
Secondary ID [1] 303735 0
none
Universal Trial Number (UTN)
Trial acronym
D4Ds
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity: BMI over 30kg/m2 321177 0
Male infertility 321178 0
Low-nutrient diet. 321179 0
Condition category
Condition code
Reproductive Health and Childbirth 318976 318976 0 0
Fertility including in vitro fertilisation
Diet and Nutrition 320574 320574 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men allocated to the intervention group will be prescribed the CSIRO Total Well-being Diet for Men and will speak (over the phone) with a clinical dietitian (30 min sessions) for four sessions over the 12 week intervention period (1st, 2nd, 6th and 11th week).
At these meetings, the study Clinical Dietitian will give a guided meal plan based on their lifestyle. The diets will be prescribed by the study dietitian based on their calculated daily energy requirements. Men will receive a list of foods that they can choose, including recipes, for the study duration that is adapted for their dietary preferences (e.g. vegetarian) as well as easy food swaps and alternatives. Food selections will be based on readily available foods and/or products within the marketplace.
Their weight will also be monitored through weekly self weigh ins, and their caloric intake will be altered depending on the fluctuation of weight. We aim for weight to stay +/-2kg from their weight measured at their pre-screening appointment.
3-day weight food dairies every 2 weeks will be recorded by participants to monitor/adhere to the dietary prescription.
Intervention code [1] 320046 0
Prevention
Comparator / control treatment
Men allocated to the control group will receive in hard copy the South Australian health brochures for men 'Smoking Nutrition Alcohol and Physical -activity' (SNAP) resources. 'Live life, sit less, move more; Alcohol-take control; Good sleep = good health and Fuel right, function better.
Control group
Active

Outcomes
Primary outcome [1] 326890 0
Sperm DNA damage (Halo Sperm) which is a visual assessment under a microscope
Timepoint [1] 326890 0
At completion of the 12 weeks of intervention
Secondary outcome [1] 393019 0
Semen analysis - Sperm count, sperm motility and sperm morphology which is visualised under a light microscopy (composite)
Timepoint [1] 393019 0
At completion of the 12 weeks of intervention
Secondary outcome [2] 393020 0
Reactive oxygen species in sperm by fluorescent probes measured on flow cytometery and point of care devices
Timepoint [2] 393020 0
At completion of the 12 weeks of intervention

Eligibility
Key inclusion criteria
Obese defined by a BMI of greater than or equal to 30 kg/m2 and a waist circumference greater than 102cm.

Dietary confirmation of a suboptimal low nutrient diet as determined by the CSIRO Healthy Diet Score survey greater than or equal to 60 out of 100 (~80% of all Australian men). The diet scoring system assess the quantity, quality and variety of foods consumed, where an individual’s diet score reflecting their overall compliance with the Australian Dietary Guidelines, with a higher score reflecting better compliance.

Able to read and write English.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior vasectomy or vasectomy reversal.

Un-descendent testes and suspected pathologies related to sub-fertility (i.e. varicoceles) or known genetic disorders that effect weight and fertility (i.e. Klinefelter's Syndrome, Prader-Willi or Larence-Moon-Bardet-Biedel).

Cigarettes or illicit drug use.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/07/2021
Date of last participant enrolment
Anticipated
29/09/2023
Actual
5/11/2023
Date of last data collection
Anticipated
29/12/2023
Actual
5/02/2024
Sample size
Target
50
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308141 0
Other Collaborative groups
Name [1] 308141 0
Robinsons Research Institute
Country [1] 308141 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Robinsons Research Institute
Address
Ground Floor, Norwich Centre
55 King William Street,
North Adelaide
South Australia 5006
Country
Australia
Secondary sponsor category [1] 308907 0
None
Name [1] 308907 0
Address [1] 308907 0
Country [1] 308907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308127 0
Adelaide University Human Research Ethics Committee
Ethics committee address [1] 308127 0
Ethics committee country [1] 308127 0
Australia
Date submitted for ethics approval [1] 308127 0
19/02/2021
Approval date [1] 308127 0
17/03/2021
Ethics approval number [1] 308127 0
H-2021-044

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

Contacts
Principal investigator
Name 109634 0
Dr Nicole McPherson
Address 109634 0
Level 4 Adelaide Health & Medical Sciences Building (AHMS)
Corner of George Street and North Terrace
ADELAIDE, South Australia, 5005
Country 109634 0
Australia
Phone 109634 0
+61 08 8313 8201
Fax 109634 0
Email 109634 0
[email protected]
Contact person for public queries
Name 109635 0
Nicola Mathews
Address 109635 0
Level 4 Adelaide Health & Medical Sciences Building (AHMS)
Corner of George Street and North Terrace
ADELAIDE, South Australia, 5005
Country 109635 0
Australia
Phone 109635 0
+61 400 378 103
Fax 109635 0
Email 109635 0
[email protected]
Contact person for scientific queries
Name 109636 0
Nicole McPherson
Address 109636 0
Level 4 Adelaide Health & Medical Sciences Building (AHMS)
Corner of George Street and North Terrace
ADELAIDE, South Australia, 5005
Country 109636 0
Australia
Phone 109636 0
+61 08 8313 8201
Fax 109636 0
Email 109636 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11067Informed consent form https://redcap1.adelaide.edu.au/redcap/surveys/?s=8KPYP3P4KY 
12512Study protocol    381644-(Uploaded-12-07-2021-16-16-04)-Study-related document.docx



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.