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Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men

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ClinicalTrials.gov Identifier: NCT04175678
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief Summary:
This is a controlled, randomized clinical trial to show that diet, exercise training, and their combination in overweight, physically inactive men will alter epigenetic programming to create a "healthy" sperm epigenome.

Condition or disease Intervention/treatment Phase
Healthy Lifestyle Obese Men Other: Diet Other: Exercise Not Applicable

Detailed Description:

The investigators will recruit 20 normal weight, active men and 80 obese, inactive men to compare their sperm epigenome at their baseline state.

The investigators will randomize the 80 obese, inactive men to intervention or no intervention for 12 weeks:1) observation with clinic visits; 2) low fat/low caloric diet; 3) supervised periodized strength and endurance training; and 4) low fat/ low caloric diet plus exercise training. The investigators will compare changes in their sperm epigenome within each group before and after intervention, between groups after intervention including the non-obese,active men at baseline.

The investigators will follow the 80 men in the intervention groups and re-examined their sperm epigenome at 12 weeks and then another 24 weeks after cessation of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
Actual Study Start Date : February 21, 2020
Estimated Primary Completion Date : March 3, 2025
Estimated Study Completion Date : March 3, 2025

Arm Intervention/treatment
No Intervention: Normal/Active
No intervention
No Intervention: Obese/Inactive
Observational clinic visits
Experimental: Diet
low fat/low caloric diet
Other: 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.
Other Name: low fat/low cal diet

Experimental: Exercise Training
≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity
Other: Exercise
Training will be supervised, individualized, and periodized, incorporating 3 sessions per week, 45-60 min per session for 36 sessions.

Experimental: Diet and exercise training
low fat/low caloric diet and ≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity
Other: 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.
Other Name: low fat/low cal diet

Other: Exercise
Training will be supervised, individualized, and periodized, incorporating 3 sessions per week, 45-60 min per session for 36 sessions.




Primary Outcome Measures :
  1. Diet and Exercise Modulate the Sperm Epigenome in Men [ Time Frame: 5 years ]
    Compare alterations in the sperm epigenome (DNA methylation, histone modifications, non-coding RNAs) in obese, physically inactive men before and after diet modulation and/or exercise training or no intervention, both within and between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Must have Hispanic Father and Mother from Mexico or Central America
  3. 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
    • 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 DM2, 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)
  4. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
  5. Does not meet any of the exclusion criteria.

Exclusion Criteria:

  1. Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
  2. Men participating in another clinical trial within the last 30 days prior to the first screening visit
  3. Men not living in the catchment's area of the clinic or within a reasonable distance from the site
  4. Clinically significant abnormal findings at screening except for those stated above for the obese, inactive group
  5. 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
  6. Sperm concentration below 15 million/mL in more than one of three screening samples
  7. 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)
  8. History of hypertension, including hypertension controlled with treatment in the healthy, active group
  9. Known history of reproductive dysfunction including vasectomy or infertility
  10. Known history of cardiac, renal, hepatic, cardiac or respiratory disease
  11. 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)
  12. Known or suspected alcoholism or drug abuse or chronic infections
  13. Serious digestive and/or absorptive problems, including inflammatory bowel disease and
  14. Chronic food intolerance or diarrhea that preclude adherence to the study diet.
  15. Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity.
  16. 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).
  17. History of other malignancies except: adequately treated non-melanoma skin cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175678


Contacts
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Contact: Christina Wang, MD 310-222-2503 wang@lundquist.org

Locations
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United States, California
The Lundquist Institute Recruiting
Torrance, California, United States, 90502
Contact: Elizabeth Ruiz    310-222-1728    eruiz@labiomed.org   
Contact: Xiaodan Han    310-222-1865    xhan@labiomed.org   
Sub-Investigator: Ronald Swerdloff, MD         
Sponsors and Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Christina Wang, MD The Lundquist Institute
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Responsible Party: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT04175678    
Other Study ID Numbers: 31568-01
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Hispanic Men
Healthy Men
Obese Men
Exercise
Diet