University of Copenhagen
Copenhagen, 2200, Denmark
NCT Number: NCT05368194
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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Notify Me20 year–35 year
Male
Interventional
Not applicable
Copenhagen, 2200, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: 3 weeks
Measured in million sperm per mL using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology
Time frame: 3 weeks
Measured in mL assuming the density of semen to be 1 g/ml
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
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.
Time frame: 3 weeks
Measured in kilograms using a scale (Tanita DC 430 SMA)
Time frame: 3 weeks
Calculated based on height and weight measurement using the equation BMI=kg/m^2
Time frame: 3 weeks
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Time frame: 3 weeks
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Time frame: 3 weeks
Measured using DEXA Scanner and Software (GE Lunar Prodigy)
Time frame: 3 weeks
Measured in milligrams per litre in serum
Time frame: 3 weeks
Measuring high density lipoproteins and low density lipoproteins in milligrams per litre in plasma
Time frame: 3 weeks
Measured in grams per litre in serum
Time frame: 3 weeks
Measured in nanograms per deciliter in plasma
Time frame: 3 weeks
Measured in international units per milliliter in serum
Time frame: 3 weeks
Measured in international units per liters in plasma
Time frame: 3 weeks
Measured in nanograms per milliliter in serum
Time frame: 3 weeks
Measured in picograms per milliliter in serum
Time frame: 3 weeks
Measured in picograms per milliliter in serum
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)
Time frame: 3 weeks
Measured in microunits per milliliter in serum
Time frame: 3 weeks
Measured in mmol/mol in plasma
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)
Time frame: 3 weeks
Measured in ng/mL in plasma
Time frame: 3 weeks
Measured in pmol/L in plasma
Time frame: 3 weeks
Measured in pg/mL in serum
Time frame: 3 weeks
Measured in pg/mL in serum
Time frame: 3 weeks
Measured in pg/mL in plasma
Time frame: 3 weeks
Measured in pg/ml in serum
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.
University of Copenhagen
Other
The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
Acronym: FEASST
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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