Healthy LifestyleNCT04175678
Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
A study testing Diet and Exercise in people with Healthy Lifestyle and Obese, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
This is a rigorous, controlled clinical trial designed to show that diet, exercise training, and their combination in overweight, inactive men will alter epigenetic programming to create a "healthy" sperm epigenome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Obese, Men
- What is being tested?
- Diet and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 30 Jun 2026
- Phase
- Interventional
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine within the reference range at the time of screening
- Must have Hispanic Father and Mother from Mexico or Central America
- Normal weight, active subjects:
- BMI 18.5 - 24.9 calculated as weight in Kg/ (height in cm)2
- Participates in ≥150 min/week of moderate intensity physical activity as assessed by accelerometer
- Consume < 30% of calories as fat/day
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- Fasting lipid panel within reference range or not clinically significant above the reference ranges
- Obese and physically inactive subjects:
- BMI ≥ 30 calculated as weight in Kg/ (height in cm)2 in obese subjects
- Have risk factors for developing type 2 diabetes (first degree relatives with Diabetes Mellitus type 2, BP≥130/80, HDL-cholesterol ≤ 35mg/dL or triglycerides ≥200mg/dL, fasting plasma glucose ≥100mg/dl to 125mg/dL or HgbA1c ≥ 5.7 to 6.4%, abnormal liver transaminases (not more than 3 times upper limit of normal suggestive of hepatic steatosis)
- Participates in ≤150 min/week of moderate intensity physical activity
- Consume >30 % fat as calories/day
- Stable weight for past six months prior to the first screening visit
- Willing to commit to 12 weeks of three times a week personalized exercise training
- Willing to commit to 12 weeks of weight loss diet (low fat and low calories)
- In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
- Does not meet any of the exclusion criteria.
Who cannot join
- Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
- Men participating in another clinical trial within the last 30 days prior to the first screening visit
- Men not living in the catchment's area of the clinic or within a reasonable distance from the site
- Clinically significant abnormal findings at screening except for those stated above for the obese, inactive group
- Abnormal serum chemistry values, according to local laboratory normal values that indicate chronic liver or kidney dysfunction or that may be considered clinically significant (except for obesity related abnormal laboratory tests including blood glucose, Hgb A1c, liver transaminases, lipids for the obese, active group as stated above). Other abnormal lab values may also be exclusionary, at the discretion of the investigator
- Sperm concentration below 15 million/mL in more than one of three screening samples
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- Diastolic (D) blood pressure (BP) > 30 and Systolic (S) BP > 130 mm Hg for the healthy, non-obese and active group; and diastolic (D) blood pressure (BP) > 150 and Systolic (S) BP > 100 mm Hg for the obese, inactive group on in the opinion of the investigator not suitable for exercise training (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
- History of hypertension, including hypertension controlled with treatment in the healthy, active group
- Known history of reproductive dysfunction including vasectomy or infertility
- Known history of cardiac, renal, hepatic, cardiac or respiratory disease
- A serious systemic disease such as diabetes mellitus defined by the American Diabetes Association or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above)
- Known or suspected alcoholism or drug abuse or chronic infections
- Serious digestive and/or absorptive problems, including inflammatory bowel disease and
- Chronic food intolerance or diarrhea that preclude adherence to the study diet.
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity.
- Psychiatric disorders (including eating disorders) or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
- History of other malignancies except: adequately treated non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
This is a rigorous, controlled clinical trial designed to show that diet, exercise training, and their combination in overweight, inactive men will alter epigenetic programming to create a "healthy" sperm epigenome. Our central hypotheses are: i) overweight and inactive lifestyle results in epimutations in the sperm epigenome relative to the normal epigenetic programming in lean and active men and ii) diet and exercise modulation leads to reversal of these epimutations resulting in both a healthier "phenotype" and "epigenotype" which may persist after stopping the interventions. The study is divided into three parts:
- We will recruit 20 healthy, active men and 20 obese and inactive Hispanic men between 18 and 40 years to determine the differences in sperm epigenome (DNA methylation, histone modifications and non-coding RNAs) in a cross-sectional study in obese inactive vs. healthy active Hispanic men. Only Hispanic men will be studied because of the high prevalence of obesity and inactivity in Hispanic younger men and to reduce the genetic variability influencing the epigenome.
- 80 obese and inactive men will be randomized to 4 groups of 20 men: 1) No intervention (control); 2) Low fat, low caloric diet; 3) Supervised, periodized endurance and resistance training without modification of diet; and 4) Both exercise and diet modification to characterize the plasticity of the sperm epigenome in response to 12-week diet and/or exercise training interventions in obese and inactive Hispanic men. Sperm epimutations will be compared before and after intervention within each group and between groups.
- The sperm epigenome studies in 80 men randomized to no intervention or diet and/or exercise training will be repeated at 12 and 36 weeks after cessation of interventions to Identify the persistent effects of diet and exercise training on the sperm epigenome after stopping the interventions.
Read the detailed description
This is not a clinical trial of a drug or device. This study will recruit 20 normal weight, physically active men and 80 obese, physically inactive Hispanic men aged between 18 and 40 years. The normal weight, active men will be studied at baseline only, whereas the obese, inactive men will be randomized and studied at baseline, after 12 weeks of diet modulation or exercise training. During the intervention period the participant will come to the study site at weeks 2, 4, 8, and 12. These men will be reassessed at 24 and 48 weeks (12 and 24 weeks) after cessation of intervention.
All research participants will be screened by medical history, physical examination, safety laboratory tests and depending on the BMI be eligible for the non-obesity or obese group. They will be provided with an accelerometer and nutritional survey and will return on day -14. If they meet the eligibility criteria then the non-obese, active men will be come for tests on day 1 and not further visits are required. The obese, inactive men and if they meet the criteria of that group they will be randomized to 1). No intervention; 2). Low fat and low caloric diet, 3). Exercise training; and 4) both diet modulation and exercise training for 12 weeks. Then they will be followed at 24 week and 48 weeks after start of treatment
- Conditions
- Healthy Lifestyle, Obese, Men
- Being tested
- Diet, Exercise, Standard care
- Keywords
- Hispanic Men, Healthy Men, Obese Men, Exercise, Diet
- Medical subject headings
- Obesity, Multiple Endocrine Neoplasia Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called low fat/low cal diet
Participants will receive delivered meals every 4 weeks for three months of a variety of foods for breakfast, lunch, dinner, two snacks, and an additional snack or dessert for each day.
ExerciseOther
Training will be supervised, individualized, and periodized, incorporating 3 sessions per week, 45-60 min per session for 36 sessions.
Standard careOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Normal/Active | Active comparator | No intervention Receives: Other: Standard care |
| Obese/Inactive | Placebo comparator | Observational clinic visits Receives: Other: Standard care |
| Diet | Experimental | low fat/low caloric diet Receives: Other: Diet |
| Exercise Training | Experimental | ≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity Receives: Other: Exercise |
| Diet and exercise training | Experimental | low fat/low caloric diet and ≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity Receives: Other: Diet; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the sperm epigenome
The Primary endpoint is to compare alterations in the sperm epigenome (DNA methylation, histone modifications, non-coding RNAs) in obese, physically inactive men before and following diet modulation and/or exercise training; this will be contrasted to a parallel no intervention group.
Measured: 5 years
Secondary outcomes (5)
Sperm Epigenetic Signals
- Compare differential sperm epigenetic signals between healthy, active Hispanic men at baseline with obese inactive men at baseline, and then after 12 weeks of diet modulation and/or exercise training or no intervention.
Measured: 5 years
Effects of Diet and Exercise Training on the Sperm Epigenome
- Characterize the effects of diet and exercise training on the sperm epigenome after stopping the interventions by comparing epigenetic data generated at the end of intervention, week 12, to data at week 24 and 48 after cessation of intervention;
Measured: 5 years
Effects of Diet or /and Exercise on Phenotypic Features
- Measure effects of a 12-week diet or/and exercise intervention (or 12 weeks of no intervention) in obese, inactive men by comparing changes in clinical/phenotype outcomes from baseline to end of study in Weight, BMI, Waist/Hip ratio, Glucose, Insulin, HOMA-IR, HbA1c, Plasma cholesterol, LDL, HDL, Triglyceride, VO2peak, muscle torque, and nutrient intake.
Measured: 5 years
Analyze persistent effects of diet and/or exercise
- Analyze the persistent effects (12 and 24 weeks after cessation of intervention) of the three intervention (diet, exercise, diet + exercise) groups and the obese, inactive no intervention control group.
Measured: 5 years
Correlate alterations in sperm epigenome with clinical and biochemical fitness biomarkers
- Characterize and correlate the alternations in sperm epigenome with clinical and biochemical and "fitness" biomarkers from baseline to 12 weeks of diet and/or exercise training or no modulation in obese, inactive men.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start21 Feb 2020
- Primary completion3 Sep 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Christina C L Wang, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Christina Wang, MD, Principal investigator, The Lundquist Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175678
- Sponsor's protocol ID
- 31568-01
- Other IDs
- 1P50HD098593-01
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will present the data first in abstract form in the Center's Annual Scientific Meeting (Retreat), then at national and international meetings. The data will be analyzed and published according to NIH guideline for publication and accepted manuscripts will be deposited to Pub Med Central to ensure public access.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
- ClinicalTrials.gov ID
- NCT04175678
- Acronym / sponsor ID
- 31568-01
- Conditions
- Healthy Lifestyle, Obese, Men
- Keywords
- Hispanic Men, Healthy Men, Obese Men, Exercise, Diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Nov 2019 (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 rigorous, controlled clinical trial designed to show that diet, exercise training, and their combination in overweight, inactive men will alter epigenetic programming to create a "healthy" sperm epigenome. Our central hypotheses are: i) overweight and inactive lifestyle results in epimutations in the sperm epigenome relative to the normal epigenetic programming in lean and active men and ii) diet and exercise modulation leads to reversal of these epimutations resulting in both a healthier "phenotype" and "epigenotype" which may persist after stopping the interventions. The study is divided into three parts:
- We will recruit 20 healthy, active men and 20 obese and inactive Hispanic men between 18 and 40 years to determine the differences in sperm epigenome (DNA methylation, histone modifications and non-coding RNAs) in a cross-sectional study in obese inactive vs. healthy active Hispanic men. Only Hispanic men will be studied because of the high prevalence of obesity and inactivity in Hispanic younger men and to reduce the genetic variability influencing the epigenome.
- 80 obese and inactive men will be randomized to 4 groups of 20 men: 1) No intervention (control); 2) Low fat, low caloric diet; 3) Supervised, periodized endurance and resistance training without modification of diet; and 4) Both exercise and diet modification to characterize the plasticity of the sperm epigenome in response to 12-week diet and/or exercise training interventions in obese and inactive Hispanic men. Sperm epimutations will be compared before and after intervention within each group and between groups.
- The sperm epigenome studies in 80 men randomized to no intervention or diet and/or exercise training will be repeated at 12 and 36 weeks after cessation of interventions to Identify the persistent effects of diet and exercise training on the sperm epigenome after stopping the interventions.
Detailed description
This is not a clinical trial of a drug or device. This study will recruit 20 normal weight, physically active men and 80 obese, physically inactive Hispanic men aged between 18 and 40 years. The normal weight, active men will be studied at baseline only, whereas the obese, inactive men will be randomized and studied at baseline, after 12 weeks of diet modulation or exercise training. During the intervention period the participant will come to the study site at weeks 2, 4, 8, and 12. These men will be reassessed at 24 and 48 weeks (12 and 24 weeks) after cessation of intervention.
All research participants will be screened by medical history, physical examination, safety laboratory tests and depending on the BMI be eligible for the non-obesity or obese group. They will be provided with an accelerometer and nutritional survey and will return on day -14. If they meet the eligibility criteria then the non-obese, active men will be come for tests on day 1 and not further visits are required. The obese, inactive men and if they meet the criteria of that group they will be randomized to 1). No intervention; 2). Low fat and low caloric diet, 3). Exercise training; and 4) both diet modulation and exercise training for 12 weeks. Then they will be followed at 24 week and 48 weeks after start of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal/Active | Active comparator | Other: Standard careNo intervention |
| Obese/Inactive | Placebo comparator | Other: Standard careObservational clinic visits |
| Diet | Experimental | Other: Dietlow fat/low caloric diet |
| Exercise Training | Experimental | Other: Exercise≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity |
| Diet and exercise training | Experimental | Other: Diet, Other: Exerciselow fat/low caloric diet and ≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine within the reference range at the time of screening
- Must have Hispanic Father and Mother from Mexico or Central America
- Normal weight, active subjects:
- In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
- Does not meet any of the exclusion criteria.
Key exclusion criteria (17 listed)
- Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
- Men participating in another clinical trial within the last 30 days prior to the first screening visit
- Men not living in the catchment's area of the clinic or within a reasonable distance from the site
- Clinically significant abnormal findings at screening except for those stated above for the obese, inactive group
- Abnormal serum chemistry values, according to local laboratory normal values that indicate chronic liver or kidney dysfunction or that may be considered clinically significant (except for obesity related abnormal laboratory tests including blood glucose, Hgb A1c, liver transaminases, lipids for the obese, active group as stated above). Other abnormal lab values may also be exclusionary, at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAlso: low fat/low cal dietParticipants will receive delivered meals every 4 weeks for three months of a variety of foods for breakfast, lunch, dinner, two snacks, and an additional snack or dessert for each day. | Other | Diet, Diet and exercise training |
| ExerciseTraining will be supervised, individualized, and periodized, incorporating 3 sessions per week, 45-60 min per session for 36 sessions. | Other | Diet and exercise training, Exercise Training |
| Standard careObservational | Other | Normal/Active, Obese/Inactive |
Primary outcome
Changes in the sperm epigenome
Time frame: 5 years
The Primary endpoint is to compare alterations in the sperm epigenome (DNA methylation, histone modifications, non-coding RNAs) in obese, physically inactive men before and following diet modulation and/or exercise training; this will be contrasted to a parallel no intervention group.
5 secondary outcomes
Sperm Epigenetic Signals
Time frame: 5 years
Effects of Diet and Exercise Training on the Sperm Epigenome
Time frame: 5 years
Effects of Diet or /and Exercise on Phenotypic Features
Time frame: 5 years
Analyze persistent effects of diet and/or exercise
Time frame: 5 years
Correlate alterations in sperm epigenome with clinical and biochemical fitness biomarkers
Time frame: 5 years
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 10 Mar 2026.
- Individual participant dataSharing planned: No. We will present the data first in abstract form in the Center's Annual Scientific Meeting (Retreat), then at national and international meetings. The data will be analyzed and published according to NIH guideline for publication and accepted manuscripts will be deposited to Pub Med Central to ensure public access.
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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. This study is not recruiting at the moment.
Christina Wang, MD principal investigator
The Lundquist Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Exercise in people with Healthy Lifestyle and Obese, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical 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 17 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the sperm epigenome (time frame: 5 years). 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 10 Mar 2026.