NCT05368194

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Fertility Issues
• Nutrition, Healthy
• Epigenetic Disorder
• Overnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Isocaloric Unprocessed 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.
DIETARY_SUPPLEMENT	Isocaloric Processed Diet	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.
DIETARY_SUPPLEMENT	Excess Calorie Unprocessed 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, 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.
DIETARY_SUPPLEMENT	Excess Calorie Processed Diet	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.

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2022-05-10
• Last updated: 2023-12-13

Locations

1 site across 1 country: Denmark