Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
NCT05368194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2023-12-13
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
Interventions
- 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.
Sponsors & Collaborators
-
Deakin University
collaborator OTHER -
Monash Health
collaborator OTHER -
University of Copenhagen
lead OTHER
Principal Investigators
-
Romain Barrès, PhD · University of Copenhagen Novo Nordisk Foundation Center for Basic Metabolic Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 35 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-20
- Primary Completion
- 2022-07-01
- Completion
- 2022-07-01
Countries
- Denmark
Study Locations
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