RECRUITING

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

Conditions

Healthy Lifestyle Obese Men Hispanic Men Healthy Men Obese Men Exercise Diet

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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 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: 1. 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. 2. 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. 3. 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.

Official Title

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

Quick Facts

Study Start:2020-02-21

Study Completion:2025-03-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04175678

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:18 Years to 40 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 * 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) 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.	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

Inclusion Criteria

Exclusion 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
* 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)
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.

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

Contacts and Locations

Study Contact

Christina Wang, MD

CONTACT

310-222-2503

wang@lundquist.org

Principal Investigator

Christina Wang, MD

PRINCIPAL_INVESTIGATOR

The Lundquist Institute

Study Locations (Sites)

The Lundquist Institute

Torrance, California, 90502

United States

Collaborators and Investigators

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Christina Wang, MD, PRINCIPAL_INVESTIGATOR, The Lundquist Institute

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 Date2020-02-21

Study Completion Date2025-03-03

Study Record Updates

Study Start Date2020-02-21

Study Completion Date2025-03-03

Terms related to this study

Keywords Provided by Researchers

Hispanic Men
Healthy Men
Obese Men
Exercise
Diet

Additional Relevant MeSH Terms

Healthy Lifestyle
Obese
Men