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Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST) Study: An Australian partner study conducted in male twins

Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST) Study: An Australian partner study conducted in male twins

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000194662
Acronym
FEASST study: Australia
Enrollment
50
Registered
2023-02-23
Start date
2023-03-01
Completion date
2023-10-02
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on sperm quality, integrity, content and epigenetic programming. Participants will receive dietary interventions of either a processed western dietary intake pattern - the “processed diet”, or an unprocessed, whole foods dietary intervention meeting the Australian Dietary Guidelines - the “unprocessed diet”. The main purpose of these interventions is to determine how and if the semen quality and epigenetic state of sperm are altered based on acute changes to dietary intake in men of reproductive age. We are specifically interested in determining how nutrient intake alters the epigenetic state of sperm, in a manner that has the potential to affect the development and health of offspring. This study will strengthen our understanding of how paternal lifestyle prior to conception may play a role in influencing the health and epigenetic status of future generations. It is hypothesized that men on the unprocessed diet versus men on the processed diet will induce different epigenetic changes to the sperm at regions involved in development and metabolism.

Interventions

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 wi

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.

Sponsors

Novo Nordisk Foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026