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NCT04175678 · ClinicalTrials.gov registry record · NA
Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
A NA study of Obese and Healthy Lifestyle, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04175678 is a NA study of Obese and Healthy Lifestyle that is active but no longer recruiting, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 100 participants, below the 208-participant average among 27 other Obese trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04175678, a NA study of Obese and Healthy Lifestyle, is active but no longer recruiting, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- OTHER Exercise
- OTHER Standard care
- OTHER Diet
Study Locations (1)
California
- The Lundquist Institute - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-02-21 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175678
The ClinicalTrials.gov registry entry for NCT04175678 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 208-participant average among 27 other Obese trials with a reported enrollment target (52% lower). The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obese appearing as the primary indexed condition, and to 3 interventions - of which Exercise is the first listed.
NCT04175678 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04175678 about?
NCT04175678 is a clinical study titled "Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men". 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 epimutat...
What is the current status of trial NCT04175678?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2020-02-21. Estimated completion is 2026-06-30.
What conditions does trial NCT04175678 study?
This clinical trial studies the following conditions: Obese, Healthy Lifestyle, Men.
What interventions are being tested in trial NCT04175678?
The interventions under investigation include: Exercise (OTHER), Standard care (OTHER), Diet (OTHER).
Who is sponsoring clinical trial NCT04175678?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04175678 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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