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

Nutrition, Healthy Clinical Trial

— FEASST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368194
• Other study ID #: H-20061598
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Epigenetic Disorder
• Fertility Issues
• Infertility
• Overnutrition

Intervention

Dietary Supplement:
• Isocaloric Unprocessed Diet
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
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
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
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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Deakin University, Monash Health

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing	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.	3 weeks
Secondary	Sperm Concentration	Measured in million sperm per mL using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology	3 weeks
Secondary	Semen Volume	Measured in mL assuming the density of semen to be 1 g/ml	3 weeks
Secondary	Sperm Motility	Measured in precent of sperm classified as progressively motile and non-progressively motile using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology	3 weeks
Secondary	Spermatozoa smallRNA expression via sequencing of total smallRNA species	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.	3 weeks
Secondary	Weight	Measured in kilograms using a scale (Tanita DC 430 SMA)	3 weeks
Secondary	Body Mass Index (BMI)	Calculated based on height and weight measurement using the equation BMI=kg/m^2	3 weeks
Secondary	Waist Circumference	Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)	3 weeks
Secondary	Hip Circumference	Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)	3 weeks
Secondary	Body Fat Precentage	Measured using DEXA Scanner and Software (GE Lunar Prodigy)	3 weeks
Secondary	C-reactive protein (CRP)	Measured in milligrams per litre in serum	3 weeks
Secondary	Lipoproteins	Measuring high density lipoproteins and low density lipoproteins in milligrams per litre in plasma	3 weeks
Secondary	Total protein	Measured in grams per litre in serum	3 weeks
Secondary	Testosterone	Measured in nanograms per deciliter in plasma	3 weeks
Secondary	Follicle stimulating hormone (FSH)	Measured in international units per milliliter in serum	3 weeks
Secondary	Luteinizing hormone (LH)	Measured in international units per liters in plasma	3 weeks
Secondary	Progesterone	Measured in nanograms per milliliter in serum	3 weeks
Secondary	Estradiol	Measured in picograms per milliliter in serum	3 weeks
Secondary	Oestradiol	Measured in picograms per milliliter in serum	3 weeks
Secondary	Fasting Blood Glucose	Measured in whole blood using a handheld glucometer and test strip (Contour next Blood Glucose Meter and Blood Sugar Test strip)	3 weeks
Secondary	Insulin	Measured in microunits per milliliter in serum	3 weeks
Secondary	Haemoglobin A1c (HbA1c)	Measured in mmol/mol in plasma	3 weeks
Secondary	Blood pressure	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)	3 weeks
Secondary	Leptin	Measured in ng/mL in plasma	3 weeks
Secondary	Glucagon-like peptide 1 (GLP-1)	Measured in pmol/L in plasma	3 weeks
Secondary	Gastric inhibitory peptide (GIP)	Measured in pg/mL in serum	3 weeks
Secondary	Glucagon	Measured in pg/mL in serum	3 weeks
Secondary	Ghrelin	Measured in pg/mL in plasma	3 weeks
Secondary	Fibroblast growth factor 21 (FGF-21)	Measured in pg/ml in serum	3 weeks
Secondary	Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing	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.	3 weeks