Nutrition, Healthy Clinical Trial
— FEASSTOfficial title:
The FEASST Study: Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
Verified date | December 2023 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Deakin University, Monash Health |
Denmark,
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 |