Diet and Exercise Study for Hispanic/Latino Men
At The Lundquist Institute at Harbor-UCLA, we are investigating the relationship between diet, exercise, and the health of sperm cells.
It is well known that an unhealthy diet and no physical activity in young men and women are major contributors to later-life development of obesity and health problems including heart disease and diabetes. Our research study involves Hispanic/Latino men between the ages of 18 and 40 years. We are looking for two types of Latino men – those that are of a healthy weight and lead an active lifestyle (meaning they exercise) and those that are overweight and are not active (meaning they do not exercise). Our research study will look to see if diet alone, exercise alone, or a combination of both diet and exercise changes gene expression (the way the body reacts genetically) to create “healthy” sperm. To be eligible for this study you will need to have Mexican or Central American ancestry through both of your parents.
It is well known that an unhealthy diet and no physical activity in young men and women are major contributors to later-life development of obesity and health problems including heart disease and diabetes. Our research study involves Hispanic/Latino men between the ages of 18 and 40 years. We are looking for two types of Latino men – those that are of a healthy weight and lead an active lifestyle (meaning they exercise) and those that are overweight and are not active (meaning they do not exercise). Our research study will look to see if diet alone, exercise alone, or a combination of both diet and exercise changes gene expression (the way the body reacts genetically) to create “healthy” sperm. To be eligible for this study you will need to have Mexican or Central American ancestry through both of your parents.
ClinicalTrial.gov ID Number: NCT04175678
Lean Participants
If you are a healthy and active male and choose to take part in this study, you will be in the study for about 1 month during which you will come to the research site 4 times.
Fitness and nutritional testing will be completed during visits. This will include:
Fitness and nutritional testing will be completed during visits. This will include:
- Activity monitoring.
- DEXA scan to assess body composition: body fat, muscle mass, and bone density.
- VO2 Max and Max Power Testing
- Nutritional Assessment
- General and Sperm Health Evaluation
Overweight Participants
If you are currently overweight and inactive, you will be in this study for about 1 year. During the trial you will come to the research site 13 times. Visits will include:
- Activity monitoring.
- DEXA scan to assess body composition: body fat, muscle mass, and bone density.
- VO2 Max and Max Power Testing
- Nutritional Assessment
- General and Sperm Health Evaluation
You will be randomly assigned to one of four groups for a period of 3 months during the trial:
Group 1: You make no changes to your diet and exercise.
Group 2: You follow a low-fat and low-calorie diet. The meals will be provided to you free of charge by the study center.
Group 3: You take part in an exercise training program 3 times each week. Each exercise training session will last 45-60 minutes and will be done with a licensed personal trainer.
Group 4: You follow a low fat and low-calorie diet and take part in an exercise training program 3 times each week.
Group 1: You make no changes to your diet and exercise.
Group 2: You follow a low-fat and low-calorie diet. The meals will be provided to you free of charge by the study center.
Group 3: You take part in an exercise training program 3 times each week. Each exercise training session will last 45-60 minutes and will be done with a licensed personal trainer.
Group 4: You follow a low fat and low-calorie diet and take part in an exercise training program 3 times each week.
Visits
Appointments will take place weekdays mornings at The Lundquist Institute at the Harbor-UCLA Medical Center in Torrance, CA. Participants will have to undergo medical testing and physical examinations, including providing blood and semen samples. Some participants will be given low-fat meals, exercise training, or both. Weekday morning availability is necessary.
The length of the study for overweight participants, including follow-up, is ～1 year. The screening and treatment phases of the trial will last about 4 months. The length of the study for normal-weight participants is 4-5 weeks.
Because the study involves evaluating sperm and genes, you will have to provide blood and semen samples during the study. You will have to collect the semen samples at the study site in a private room. You will also have to wear an activity tracker around your waist for 7 consecutive days removing it only to shower/bathe. You will perform an exercise test on a stationary bicycle to see how your heart and lungs respond to exercise.
There are risks related to this study that include, but are not limited to, exposure to radiation from a scan done to determine how much muscle and fat mass you have, risks related to drawing blood, and injury or muscle soreness from exercise training.
The length of the study for overweight participants, including follow-up, is ～1 year. The screening and treatment phases of the trial will last about 4 months. The length of the study for normal-weight participants is 4-5 weeks.
Because the study involves evaluating sperm and genes, you will have to provide blood and semen samples during the study. You will have to collect the semen samples at the study site in a private room. You will also have to wear an activity tracker around your waist for 7 consecutive days removing it only to shower/bathe. You will perform an exercise test on a stationary bicycle to see how your heart and lungs respond to exercise.
There are risks related to this study that include, but are not limited to, exposure to radiation from a scan done to determine how much muscle and fat mass you have, risks related to drawing blood, and injury or muscle soreness from exercise training.
Requirements
We're looking for healthy men in the Los Angles area to participate. Eligible participants must be:
- Male volunteers in good health (no serious ongoing medical issues).
- 18 to 40 years of age at the time of the enrollment visit.
- Participants must be Hispanic/Latino (in order to qualify both parents must have Mexican or Central American ancestry).
- Lean participants must have Body Mass Index of less than 25.
- Overweight participants have Body Mass Index of greater than 30.
Compensation
You will be compensated for the time spent taking part in this study. If you are in the lean group, you can receive up to $300, and if you are in the overweight group, you can receive between $900 and $1280 - depending on the intervention group you are assigned.
All exercise testing, training, and nutritional supplementation will be done at no cost to the participant.
All exercise testing, training, and nutritional supplementation will be done at no cost to the participant.
Learn More
To learn more about the study please contact the study coordinator:
Michael Massone - Clinical Coordinator at The Lundquist Institute
(310) 341-9323 (call or text)
michael.massone@lundquist.org
(310) 341-9323 (call or text)
michael.massone@lundquist.org
Our Team
The Lundquist Institute for Biomedical Innovation is a 501(c)3 independent non-profit biomedical research organization that was founded in 1952. The Institute has over more than 120 principal investigators and 400 researchers in total — MD’s, MD/Ph.D.’s, and Ph.D.’s — working on over 1,000 research studies. We are academically affiliated with the David Geffen School of Medicine at UCLA and work in partnership with the Harbor-UCLA Medical Center. Our research is funded by many sources including grants from the NIH and other government entities, Industry and teaching contracts and royalties, as well as private donors and other non-profit foundations.
Dr. Ronald Swerdloff is the Chief of the Division of Endocrinology, Department of Medicine and the Director of a World Health Organization Collaborative Center in Reproduction, a Mellon Foundation Center for Contraceptive Development and a NIH Contraceptive Clinical Trial Center. Dr. Swerdloff is also director of the Harbor-UCLA Reproductive Program. He earned his medical degree from the University of California, San Francisco, followed by residency in internal medicine at University of Washington and UCLA, and fellowships in endocrinology at the National Institute of Aging and Harbor-UCLA. He is a diplomat of the American Board of Internal Medicine (internal medicine and endocrinology). He has received many awards including the Distinguished Educator Award of the Endocrine Society and American Society of Andrology's Distinguished Andrologist Award. Dr. Swerdloff has been an invited plenary lecturer at many national and international scientific meetings. His research papers, articles, and abstracts number in the 600s, and he has edited a number of books and authored over 100 book chapters.
Dr. Wei Yan is Professor of Medicine at David Geffen School of Medicine at UCLA, and Principal Investigator at The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. His research is focused on genetic and epigenetic control of fertility, and epigenetic contribution of gametes (sperm and eggs) to fertilization, early embryonic development and adulthood health. He has published >150 peer-reviewed papers with >10,000 citations (as of April 2021). Dr. Yan received many prestigious awards, including the 2009 Society for the Study of Reproduction (SSR) Young Investigator Award, the 2012 American Society of Andrology (ASA) Young Andrologist Award, the 2013 Nevada Healthcare Hero Award for Research and Technology, the 2017 University of Nevada, Reno Outstanding Researcher Award, the 2018 SSR Research Award and the 2020 Nevada System of Higher Education Regents’ Research Award. In May 2016, Dr. Yan was named the University of Nevada Reno Foundation Professor, the highest honor the University bestows upon its faculty. In 2017, he was elected Fellow of the American Association for the Advancement of Science (AAAS). Dr. Yan is currently co-Editor-in-Chief of Biology of Reproduction, a premier journal in the field of Reproductive Biology. He likes hiking, skiing, swimming, and photography.
