Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins (FEASST)

University of Copenhagen

Status: Completed

Conditions: Epigenetic Disorder; Overnutrition; Nutrition, Healthy; Fertility Issues

Treatments: Dietary Supplement: Excess Calorie Processed Diet; Dietary Supplement: Excess Calorie Unprocessed Diet; Dietary Supplement: Isocaloric Unprocessed Diet; Dietary Supplement: Isocaloric Processed Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05368194

H-20061598

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 2 patient groups

Isocaloric Arm

Experimental group

Description:

Participants within the isocaloric arm will be provided with food provisions in accordance with their nutrition needs. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet.

Treatment:

Dietary Supplement: Isocaloric Processed Diet

Dietary Supplement: Isocaloric Unprocessed Diet

Excess Calorie Arm

Experimental group

Description:

Participants within the excess calorie arm will be provided with food provisions in accordance with their nutrition needs plus an additional 500 kilocalories per day. Participants within this arm will be further randomised to the order of first and second dietary interventions for the crossover design; unprocessed diet or processed diet.

Treatment:

Dietary Supplement: Excess Calorie Unprocessed Diet

Dietary Supplement: Excess Calorie Processed Diet