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临床试验/NCT05368194
NCT05368194已完成不适用

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

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Spermatozoa DNA Methylation via Reduced Representation Bisulfite Sequencing

时间窗: 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.

次要结局

  • Glucagon-like peptide 1 (GLP-1)(3 weeks)
  • C-reactive protein (CRP)(3 weeks)
  • Follicle stimulating hormone (FSH)(3 weeks)
  • Body Mass Index (BMI)(3 weeks)
  • Hip Circumference(3 weeks)
  • Testosterone(3 weeks)
  • Leptin(3 weeks)
  • Gastric inhibitory peptide (GIP)(3 weeks)
  • Glucagon(3 weeks)
  • Sperm Concentration(3 weeks)
  • Semen Volume(3 weeks)
  • Sperm Motility(3 weeks)
  • Weight(3 weeks)
  • Body Fat Precentage(3 weeks)
  • Total protein(3 weeks)
  • Progesterone(3 weeks)
  • Estradiol(3 weeks)
  • Fasting Blood Glucose(3 weeks)
  • Spermatozoa smallRNA expression via sequencing of total smallRNA species(3 weeks)
  • Lipoproteins(3 weeks)
  • Insulin(3 weeks)
  • Haemoglobin A1c (HbA1c)(3 weeks)
  • Waist Circumference(3 weeks)
  • Blood pressure(3 weeks)
  • Oestradiol(3 weeks)
  • Ghrelin(3 weeks)
  • Peripheral blood mononuclear cell (PBMC) DNA methylation via Reduced Representation Bisulfite Sequencing(3 weeks)
  • Luteinizing hormone (LH)(3 weeks)
  • Fibroblast growth factor 21 (FGF-21)(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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