Diet, HealthyDIG 'EMNCT06252922
Diet-Induced Changes in GEnetic Material
An observational study of Diet, Healthy and Body Weight, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Body Weight, Metabolic Disturbance
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: This study will enroll healthy men from the greater Baton Rouge area who meet the above eligibility criteria and are willing to participate in this research trial.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Emily Flanagan, PhD, 225-763-2828, Emily.Flanagan@pbrc.edu
Emily Flanagan, PhD
About this study
Official title: A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes
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.
Read the detailed description
The Paternal Origins of Health and Disease (POHaD) hypothesis was introduced to emphasize the need for research on paternal transmission of environmental exposures on offspring disease development. Paternal exposure to an obesogenic diet has been shown to imprint epigenetic predisposition to metabolic diseases which can be evident in offspring for up to 5 generations. In support, observational studies in men show that high-fat diets and diets high in processed foods significantly reduced the quantity and quality of sperm, including motility, morphology, and concentration, and DNA methylation of genes associated with obesity and cardiometabolic dysfunction. Yet, there are no experimental diet manipulation studies in males to understand the contribution of an acute obesogenic diet (i.e., high-fat) on DNA methylation of genes associated with obesity and cardiometabolic diseases in male gametes.
The research aims of this study are to: 1) measure DNA methylation of genes in semen in response to a healthy and high-fat diet, 2) examine metabolic flexibility in response to a healthy and high fat diet and its contribution to DNA methylation in semen, and 3) examine the metabolic and inflammatory milieu in response to a healthy and high fat diet and its contribution to DNA methylation in semen. To achieve these aims, we will conduct a cross-sectional, observational study in 10 healthy male participants 20-35 years of age using two diets (Healthy Diet: 27% Fat, 55% Carbohydrate, 15% Protein followed by a High-Fat Diet: 50% Fat, 35% Carbohydrate, 15% Protein).
- Conditions
- Diet, Healthy, Body Weight, Metabolic Disturbance
- Keywords
- Healthy Weight, High-Fat Diet, Sperm DNA Methylation, Metabolic Flexibility, DNA Damage, Substrate Flux, Preconception
- Medical subject headings
- Body Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA methylation
Incidence of DNA methylation (whole genome/epigenome wide) of genes in sperm measured using bisulphate sequencing
Measured: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet
Secondary outcomes (1)
Sperm DNA Damage
Comet Assay to determine DNA fragmentation in sperm.
Measured: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start11 Nov 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily W. Flanagan, MS, PhD, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252922
- Sponsor's protocol ID
- PBRC 2023-043
- Acronym
- DIG 'EM
- Status last verified
- May 2025
- First submitted
- 4 Jan 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes
- ClinicalTrials.gov ID
- NCT06252922
- Acronym / sponsor ID
- DIG 'EM / PBRC 2023-043
- Conditions
- Diet, Healthy, Body Weight, Metabolic Disturbance
- Keywords
- Healthy Weight, High-Fat Diet, Sperm DNA Methylation, Metabolic Flexibility, DNA Damage, Substrate Flux, Preconception
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Paternal Origins of Health and Disease (POHaD) hypothesis was introduced to emphasize the need for research on paternal transmission of environmental exposures on offspring disease development. Paternal exposure to an obesogenic diet has been shown to imprint epigenetic predisposition to metabolic diseases which can be evident in offspring for up to 5 generations. In support, observational studies in men show that high-fat diets and diets high in processed foods significantly reduced the quantity and quality of sperm, including motility, morphology, and concentration, and DNA methylation of genes associated with obesity and cardiometabolic dysfunction. Yet, there are no experimental diet manipulation studies in males to understand the contribution of an acute obesogenic diet (i.e., high-fat) on DNA methylation of genes associated with obesity and cardiometabolic diseases in male gametes.
The research aims of this study are to: 1) measure DNA methylation of genes in semen in response to a healthy and high-fat diet, 2) examine metabolic flexibility in response to a healthy and high fat diet and its contribution to DNA methylation in semen, and 3) examine the metabolic and inflammatory milieu in response to a healthy and high fat diet and its contribution to DNA methylation in semen. To achieve these aims, we will conduct a cross-sectional, observational study in 10 healthy male participants 20-35 years of age using two diets (Healthy Diet: 27% Fat, 55% Carbohydrate, 15% Protein followed by a High-Fat Diet: 50% Fat, 35% Carbohydrate, 15% Protein).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will enroll healthy men from the greater Baton Rouge area who meet the above eligibility criteria and are willing to participate in this research trial.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sperm DNA methylation
Time frame: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet
Incidence of DNA methylation (whole genome/epigenome wide) of genes in sperm measured using bisulphate sequencing
1 secondary outcome
Sperm DNA Damage
Time frame: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Official Study Landing PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy and Body Weight, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Flanagan, PhD ((225) 763-2828, Emily.Flanagan@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm DNA methylation (time frame: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.