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

NCT05368194 | Completed

• 1 other identifier: H-20061598
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fertility Issues; Nutrition, Healthy; Epigenetic Disorder; Overnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Sperm Concentration

  3 weeks

• Semen Volume

  3 weeks

• Sperm Motility

  3 weeks

• Spermatozoa smallRNA expression via sequencing of total smallRNA species

  3 weeks

• Weight

  3 weeks

Study Arms (2)

Isocaloric Arm

EXPERIMENTAL

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

Excess Calorie Arm

EXPERIMENTAL

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

Interventions

Isocaloric Unprocessed Diet DIETARY_SUPPLEMENT

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 Arm

Isocaloric Processed Diet DIETARY_SUPPLEMENT

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.

Isocaloric Arm

Excess Calorie Unprocessed Diet DIETARY_SUPPLEMENT

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 Arm

Excess Calorie Processed Diet DIETARY_SUPPLEMENT

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.

Excess Calorie Arm

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Deakin University: collaborator
• Monash Health: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Infertility; Overnutrition

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Romain Barrès, PhD

  University of Copenhagen Novo Nordisk Foundation Center for Basic Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: May 10, 2022
• Study Start: October 20, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)