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Completed

NCT Number: NCT05368194

Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isocaloric Unprocessed Diet

Dietary Supplement

Intervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system.

Isocaloric Processed Diet

Dietary Supplement

Intervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system.

Excess Calorie Unprocessed Diet

Dietary Supplement

Intervention consists of an unprocessed diet meeting the Nordic and Australian Dietary Guidelines for food groups and micronutrients, wherein participants will be supplied with food providing kilocalories (kcal) in accordance with their nutritional needs as calculated based on theSchofield equation based on their weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of unprocessed/minimally processed foods and processed culinary ingredients in accordance with the NOVA classification system.

Excess Calorie Processed Diet

Dietary Supplement

Intervention consists of a processed diet based on the dietary intake pattern resembling a processed western dietary intake pattern representative of the typical intake pattern of American men aged 19- 50, wherein participants will be supplied with food providing kcals in accordance with their nutritional needs as calculated based on the Schofield equation based on their height, weight, activity multiplier, and age at baseline, plus an excess of 500 kcal per day. Almost all food and beverage products provided during this treatment to fall into the category of processed foods and ultra-processed foods in accordance with the NOVA classification system.

Primary outcomes

  1. Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing

    Time frame: 3 weeks

    Differential methylation of CpG sites within mature spermatozoa determined from extracted genomic DNA which has undergone library preperation with Ovation® RRBS Methyl-Seq (NuGEN Technologies) and sequenced on a NextSeq Illumina platform.

Secondary outcomes

  1. Sperm Concentration

    Time frame: 3 weeks

    Measured in million sperm per mL using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology

  2. Semen Volume

    Time frame: 3 weeks

    Measured in mL assuming the density of semen to be 1 g/ml

  3. Sperm Motility

    Time frame: 3 weeks

    Measured in precent of sperm classified as progressively motile and non-progressively motile using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology

  4. Spermatozoa smallRNA expression via sequencing of total smallRNA species

    Time frame: 3 weeks

    Differential expression of small RNA species within mature spermatozoa performed by generation of RNA sequencing libraries using NEXTFLEX® Small RNA-Seq Kit for Illumina (PerkinElmer), according to the manufacturer's instructions, and sequenced on a NextSeq Illumina platform.

  5. Weight

    Time frame: 3 weeks

    Measured in kilograms using a scale (Tanita DC 430 SMA)

  6. Body Mass Index (BMI)

    Time frame: 3 weeks

    Calculated based on height and weight measurement using the equation BMI=kg/m^2

  7. Waist Circumference

    Time frame: 3 weeks

    Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)

  8. Hip Circumference

    Time frame: 3 weeks

    Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)

  9. Body Fat Precentage

    Time frame: 3 weeks

    Measured using DEXA Scanner and Software (GE Lunar Prodigy)

  10. C-reactive protein (CRP)

    Time frame: 3 weeks

    Measured in milligrams per litre in serum

  11. Lipoproteins

    Time frame: 3 weeks

    Measuring high density lipoproteins and low density lipoproteins in milligrams per litre in plasma

  12. Total protein

    Time frame: 3 weeks

    Measured in grams per litre in serum

  13. Testosterone

    Time frame: 3 weeks

    Measured in nanograms per deciliter in plasma

  14. Follicle stimulating hormone (FSH)

    Time frame: 3 weeks

    Measured in international units per milliliter in serum

  15. Luteinizing hormone (LH)

    Time frame: 3 weeks

    Measured in international units per liters in plasma

  16. Progesterone

    Time frame: 3 weeks

    Measured in nanograms per milliliter in serum

  17. Estradiol

    Time frame: 3 weeks

    Measured in picograms per milliliter in serum

  18. Oestradiol

    Time frame: 3 weeks

    Measured in picograms per milliliter in serum

  19. Fasting Blood Glucose

    Time frame: 3 weeks

    Measured in whole blood using a handheld glucometer and test strip (Contour next Blood Glucose Meter and Blood Sugar Test strip)

  20. Insulin

    Time frame: 3 weeks

    Measured in microunits per milliliter in serum

  21. Haemoglobin A1c (HbA1c)

    Time frame: 3 weeks

    Measured in mmol/mol in plasma

  22. Blood pressure

    Time frame: 3 weeks

    Systolic and Diastolic blood pressure measured in mmHg using an automatic blood pressure cuff (Omron M6 Comfort Automatic Upper Arm Blood Pressure Monitor, 22-42cm)

  23. Leptin

    Time frame: 3 weeks

    Measured in ng/mL in plasma

  24. Glucagon-like peptide 1 (GLP-1)

    Time frame: 3 weeks

    Measured in pmol/L in plasma

  25. Gastric inhibitory peptide (GIP)

    Time frame: 3 weeks

    Measured in pg/mL in serum

  26. Glucagon

    Time frame: 3 weeks

    Measured in pg/mL in serum

  27. Ghrelin

    Time frame: 3 weeks

    Measured in pg/mL in plasma

  28. Fibroblast growth factor 21 (FGF-21)

    Time frame: 3 weeks

    Measured in pg/ml in serum

  29. Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing

    Time frame: 3 weeks

    Differential methylation of CpG sites within PBMCs determined from extracted genomic DNA which has undergone library preperation with Ovation® RRBS Methyl-Seq (NuGEN Technologies) and sequenced on a NextSeq Illumina platform.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Deakin University
  • Monash Health

Registry information

Official study title

The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins

Acronym: FEASST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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