RECRUITING

Diet-Induced Changes in GEnetic Material

Conditions

Diet, Healthy Body Weight Metabolic Disturbance Healthy Weight High-Fat Diet Sperm DNA Methylation Metabolic Flexibility DNA Damage Substrate Flux Preconception

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.

Official Title

A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes

Quick Facts

Study Start:2023-11-11

Study Completion:2024-10-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06252922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 35 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Male based on biological sex * Age 20-35 years * BMI between 18.5 and 24.9 kg/m2 * White/Caucasian * Willing to consume pre-prepared meals * Willing to wear an accelerometer and continuous glucose monitor (CGM) * Willing to track diet intake * Willing to stay 24 hours, including overnight in a research clinic * Willing to provide blood and sperm samples * Willing to consent to whole-genome sequencing of DNA	* Unstable weight in the last 3 months (±5% weight loss or gain) * Shift work or working in a factory setting * Habitual smoking or use of tobacco products, including vaping, within the past 6 months. * History of clinically diagnosed diabetes * Hypertension (\>140/90 mmHg measured at screening) * Has undergone bariatric surgery * History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer * History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) * Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) or food allergies associated with study foods. * Currently engaging in \>150 minutes moderate-intensity or \>75 minutes of vigorous-intensity physical activity each week * Drinking more than 14 servings of beer or alcohol per week * Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)

Inclusion Criteria

Exclusion Criteria

* Male based on biological sex
* Age 20-35 years
* BMI between 18.5 and 24.9 kg/m2
* White/Caucasian
* Willing to consume pre-prepared meals
* Willing to wear an accelerometer and continuous glucose monitor (CGM)
* Willing to track diet intake
* Willing to stay 24 hours, including overnight in a research clinic
* Willing to provide blood and sperm samples
* Willing to consent to whole-genome sequencing of DNA

* Unstable weight in the last 3 months (±5% weight loss or gain)
* Shift work or working in a factory setting
* Habitual smoking or use of tobacco products, including vaping, within the past 6 months.
* History of clinically diagnosed diabetes
* Hypertension (\>140/90 mmHg measured at screening)
* Has undergone bariatric surgery
* History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer
* History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
* Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) or food allergies associated with study foods.
* Currently engaging in \>150 minutes moderate-intensity or \>75 minutes of vigorous-intensity physical activity each week
* Drinking more than 14 servings of beer or alcohol per week
* Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)

Contacts and Locations

Study Contact

Emily Flanagan, PhD

CONTACT

(225) 763-2828

Emily.Flanagan@pbrc.edu

Study Locations (Sites)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808

United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-11

Study Completion Date2024-10-03

Study Record Updates

Study Start Date2023-11-11

Study Completion Date2024-10-03

Terms related to this study

Keywords Provided by Researchers

Healthy Weight
High-Fat Diet
Sperm DNA Methylation
Metabolic Flexibility
DNA Damage
Substrate Flux
Preconception

Additional Relevant MeSH Terms

Diet, Healthy
Body Weight
Metabolic Disturbance