An interventional study of Isocaloric Unprocessed Diet and Isocaloric Processed Diet in Fertility Issues, Nutrition, Healthy and Epigenetic Disorder, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 43 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →University of Copenhagen is the lead sponsor of 466 studies on the registry; 64 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Evidence of dysregulated metabolism, characterized by the occurrence of any one of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Isocaloric Unprocessed Diet · Dietary Supplement: Isocaloric Processed Diet
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.
Dietary Supplement: Excess Calorie Unprocessed Diet · Dietary Supplement: Excess Calorie Processed 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.
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.
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.
Time frame: 3 weeks
Sperm Concentration
Measured in million sperm per mL using LensHooke X1 Pro Semen Quality Analyser and Microscopy-based methodology
Time frame: 3 weeks
Semen Volume
Measured in mL assuming the density of semen to be 1 g/ml
Time frame: 3 weeks
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
Time frame: 3 weeks
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.
Time frame: 3 weeks
Weight
Measured in kilograms using a scale (Tanita DC 430 SMA)
Time frame: 3 weeks
Body Mass Index (BMI)
Calculated based on height and weight measurement using the equation BMI=kg/m\^2
Time frame: 3 weeks
Waist Circumference
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Time frame: 3 weeks
Hip Circumference
Measured in centimetres using a flexible measuring tape (SECA Measuring Tape 201 cm)
Time frame: 3 weeks
Body Fat Precentage
Measured using DEXA Scanner and Software (GE Lunar Prodigy)
Time frame: 3 weeks
C-reactive protein (CRP)
Measured in milligrams per litre in serum
Time frame: 3 weeks
Lipoproteins
Measuring high density lipoproteins and low density lipoproteins in milligrams per litre in plasma
Time frame: 3 weeks
Total protein
Measured in grams per litre in serum
Time frame: 3 weeks
Testosterone
Measured in nanograms per deciliter in plasma
Time frame: 3 weeks
Follicle stimulating hormone (FSH)
Measured in international units per milliliter in serum
Time frame: 3 weeks
Luteinizing hormone (LH)
Measured in international units per liters in plasma
Time frame: 3 weeks
Progesterone
Measured in nanograms per milliliter in serum
Time frame: 3 weeks
Estradiol
Measured in picograms per milliliter in serum
Time frame: 3 weeks
Oestradiol
Measured in picograms per milliliter in serum
Time frame: 3 weeks
Fasting Blood Glucose
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
Insulin
Measured in microunits per milliliter in serum
Time frame: 3 weeks
Haemoglobin A1c (HbA1c)
Measured in mmol/mol in plasma
Time frame: 3 weeks
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)
Time frame: 3 weeks
Leptin
Measured in ng/mL in plasma
Time frame: 3 weeks
Glucagon-like peptide 1 (GLP-1)
Measured in pmol/L in plasma
Time frame: 3 weeks
Gastric inhibitory peptide (GIP)
Measured in pg/mL in serum
Time frame: 3 weeks
Glucagon
Measured in pg/mL in serum
Time frame: 3 weeks
Ghrelin
Measured in pg/mL in plasma
Time frame: 3 weeks
Fibroblast growth factor 21 (FGF-21)
Measured in pg/ml in serum
Time frame: 3 weeks
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.
Time frame: 3 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Jul 2022, 8 months.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 8 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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