Clinical trial NCT05368194: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
Official title: The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Issues
Nutrition, Healthy
Epigenetic Disorder
Overnutrition
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Deakin University
name: Monash Health
First posted: 2022-05-10
Enrollment: 43
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming.

Detailed description: The FEASST study has been designed to determine the impact of diet on the content, quality, and genetic programming of sperm. They are specifically interested in determining if a man's diet plays a role in influencing the health of his potential, future offspring through modifications of the sperm. Previous research has highlighted that certain dietary patterns in fathers-to-be may lead to variable health outcome for their children. However, the specific effect of a man's diet has yet to be fully understood. This study will help understand the impact of a man's diet on semen quality and potential downstream implications for child health, to aid in the development of dietary guidelines for future fathers-to-be.

For this study, male participants will be provided with two prescribed diets for three-week increments punctuated by a three month break. Health information and biological samples such as blood, semen, and saliva will be collected from study participants throughout the five month period. The diets will consist of a 'Processed diet', mimicking a traditional Western dietary intake pattern and an 'Unprocessed diet', based upon current dietary guidelines at quantities either adequate for the participants energetic needs or 500 calories in excess per day.

Patient information and samples will be collected before and after each dietary intervention. Aspects of patient health examined at various time points include weight, body fat percentage, sperm quality, epigenetic sequencing, serum levels of metabolic parameters, and survey information surrounding health history, typical diet, physical activity patterns, and treatment adherence.

Eligibility criteria: Inclusion Criteria:

* Male
* 20 to 35 years old
* BMI 18.5 to 30
* Located within the Copenhagen region
* Fluent in English and/or Danish language
* Sperm concentration of \>15 mil/mL according to the WHO's criteria for semen quality
* Semen volume of \>1.5mL mL according to the WHO's criteria for semen quality
* Clinician approval for participation in study
* Obtained informed consent

Exclusion Criteria:

* Self-reported history of serious or chronic illness
* Self-reported history of Obesity
* History of any food restrictions
* History of allergies to any food products
* History of disordered eating
* Record of current use of drugs, alcohol (\>14 units per week and/or chronic binge drinking), and/or tobacco/nicotine products within the past month
* Current use of prescription medication
* Engage in \> 200 minutes of vigorous aerobic exercise per week
* 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:

  * Waist circumference \>102 cm
  * Blood pressure \> 130/85 mm Hg

Primary outcomes:
measure: Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing
timeFrame: 3 weeks
Secondary outcomes:
measure: Sperm Concentration
timeFrame: 3 weeks
measure: Semen Volume
timeFrame: 3 weeks
measure: Sperm Motility
timeFrame: 3 weeks
measure: Spermatozoa smallRNA expression via sequencing of total smallRNA species
timeFrame: 3 weeks
measure: Weight
timeFrame: 3 weeks
measure: Body Mass Index (BMI)
timeFrame: 3 weeks
measure: Waist Circumference
timeFrame: 3 weeks
measure: Hip Circumference
timeFrame: 3 weeks
measure: Body Fat Precentage
timeFrame: 3 weeks
measure: C-reactive protein (CRP)
timeFrame: 3 weeks
measure: Lipoproteins
timeFrame: 3 weeks
measure: Total protein
timeFrame: 3 weeks
measure: Testosterone
timeFrame: 3 weeks
measure: Follicle stimulating hormone (FSH)
timeFrame: 3 weeks
measure: Luteinizing hormone (LH)
timeFrame: 3 weeks
measure: Progesterone
timeFrame: 3 weeks
measure: Estradiol
timeFrame: 3 weeks
measure: Oestradiol
timeFrame: 3 weeks
measure: Fasting Blood Glucose
timeFrame: 3 weeks
measure: Insulin
timeFrame: 3 weeks
measure: Haemoglobin A1c (HbA1c)
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
measure: Leptin
timeFrame: 3 weeks
measure: Glucagon-like peptide 1 (GLP-1)
timeFrame: 3 weeks
measure: Gastric inhibitory peptide (GIP)
timeFrame: 3 weeks
measure: Glucagon
timeFrame: 3 weeks
measure: Ghrelin
timeFrame: 3 weeks
measure: Fibroblast growth factor 21 (FGF-21)
timeFrame: 3 weeks
measure: Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen Novo Nordisk Foundation Center for Basic Metabolic Research
name: Romain Barrès, PhD
role: PRINCIPAL_INVESTIGATOR
References: