FEAS[Singletons]T

Food intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins – Singletons Study.

A human dietary intervention study where participants receive different commonly consumed diet patterns and we are examining the impact it has on epigenetic markers in the sperm. This part of the study is with individual people, singletons. 

Why?

It is known that the epigenome of sperm cells can be changed when men are exposed to lifestyle changes, such as increased exercise or weight loss. Further, these epigenetic changes have been noted to occur at places on the DNA that may impact the health and development of their children. One lifestyle choice of which we are still working to understand the impact on the quality and epigenome of sperm is diet. Previous research in animals has shown that certain diets in fathers-to-be can potentially lead to altered health outcomes in their children. To help us better understand how the current modern diets of men may be effecting their sperm we designed the Food intake and Epigenetic Alteration in Spermatozoa of Singletons and Twins, also known as the FEASST study.

How?

We will provide male participants with two specific diets, and we will collect health information and biological samples such as blood, semen, and saliva throughout. The diets will consist of a ‘Processed’ and ‘Unprocessed’ version. The aim of these two diets is to study the health effect of consuming a diet matching what men are supposed to eat versus what they are actually eating. The ‘Processed’ diet is based on the average food intake of American men and is made to represent what men of child-rearing age are presently eating and consists of food products that have undergone industrial processing with added sugar, enriched in saturated fat, cholesterol, and sodium.  The ‘Unprocessed’ diet is based on the dietary guidelines for men from several countries, including Australia, the US, and Nordic Nations, meant to represent the current nutritional recommendations that are given to young men for optimal health and consists of fruits, vegetables, whole grains, unsaturated fats, lean protein, and fibre.

Participants will be given these diets for three-weeks, followed by a three-month break, and then another three-weeks eating the diet opposite to the one they had during the first three-weeks. Throughout the study various measurements are taken such as: body weight, sperm quality, blood levels of markers related to reproduction and metabolism, and survey information surrounding mental and physical health.

Once the study is completed, blood and semen samples will be further analysed in the lab to identify any epigenetic changes or patterns. We will look at epigenetic changes such as presence of RNA species and epigenetic-modifying features that interact with gene expression. We will analyse data from these experimental procedures to determine the relationship of different diets on the characteristics of sperm

2019 - 2024

Timeline: FEAS[Singletons]T

November, 2019

#1 - Study leader hired

Jessica Preston was hired by the GECKO consortium with funding from The Copenhagen Bioscience PhD Program to conceptualize and plan the FEASST Singletons and Twins studies.

September, 2020

#2 - Study leader accepted into the Ph.D. school

Jessica was officially enrolled as a PhD Student at the Novo Nordisk Foundation Centre for Basic Metabolic research, University of Copenhagen

September, 2020

#3 - Study submitted for ethical review

The FEASST Singletons study and all accompanying research study documents were submitted to the Capital Regions of Denmark Committee on Health Research Ethics

January, 2021

#4 - Received preliminary feedback from the research ethics committee

Comments on the original study documents were received, suggesting changes and amendments to the study design and documentation in order to ensure compliance with health research ethical standards.

March, 2021

#5 - Submitted amendments to the ethical review board

Study documents were edited in accordance with the ethics committee’s suggestions and re-submitted as an amendment for further ethical review*.

*Processing of reviewing a research study to determine fulfilment of a country or institution’s criteria for the conduct of ethical research.

October, 2021

#6 - Received ethical approval

The research study received official approval from the Region Hovedstaden Videnskabsetiske komitéer (Copenhagen Capital Region Research Ethics Committee) in order to begin study conduct.

Information on ethical approval can be found here: https://clinicaltrials.gov/study/NCT05368194

October, 2021

#7 - Started recruitment of study participants

Recruitment of study participants commenced, including publicising the study, screening applicants, and determining the fulfilment of eligibility criteria* by potential participants.

*The specifications that an individual must meet in order to be included in a clinical research study, such as a specified sex, age range, or health condition.

 

January, 2022

#8 - Study Period Commenced

The selected study participants began the nutrition intervention* and attended a series of 6 appointments at the study center to assess health changes.

*A type of research study in which research participants are given a specific diet for a set period of time.

July, 2022

#9 - Completion of Study Period

The nutrition intervention was complete, and all study participants finished their dietary period and attended all study appointments

October, 2022

#10 - Started data analysis

Statistical analysis conducted on all health information collected throughout the nutrition intervention.

February, 2023

#11 - Started laboratory analysis

Laboratory-based measurements on frozen biological materials* from study participants was completed to determine the levels of various haematological parameters** and epigenetic parameters***.

* Human tissues collected from study participants, including blood, saliva and semen.

** The levels of various compounds within the blood used to determine physiological and health status.

***The pattern and frequency of changes to the DNA regulation, including the levels of DNA methylation and smallRNA expression.

#12 - Laboratory analysis completed

All laboratory-based measurement of the collected tissues completed.

December, 2023

#13 - Multiomics analysis commenced

Biostatistical* interpretation of the complex parameters assessed from the study participant biological material, including statistical analysis of epigenetic parameters and metabolomic parameters**.

*Statistical approaches related to biological data sets such as a clinical research study

**The measurement of the variety of compounds involved in metabolism identified in the biological materials.

April, 2024

#14 - Multiomics analysis expected to be completed

Statistical interpretation of all data sets pertaining to the study is anticipated being completed.

June, 2024

#15 - Expected completion of research study

Anticipated publication of the study results and submission of the study leader’s PhD.

2019
2024
2020
2021
2022
2023

Study Leaders

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