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Diet and Exercise for Obesity-related Sperm Changes

N/A
Recruiting
Led By Christina Wang, MD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Willing to commit to 12 weeks of weight loss diet (low fat and low calories)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is designed to see if epigenetic programming in sperm changes in response to diet and exercise in obese, inactive men.

Who is the study for?
Hispanic men aged 18-40 with both parents from Mexico or Central America. Participants must be obese (BMI ≥ 30), inactive, and at risk for type 2 diabetes but in good health otherwise. They should not have serious diseases, reproductive dysfunctions, or a history of substance abuse. Men already on another trial or living far from the clinic are excluded.Check my eligibility
What is being tested?
The study tests how diet and exercise affect sperm epigenetics in overweight, inactive Hispanic men. It's divided into three parts: comparing active to inactive men's sperm, then randomizing inactive men into control, diet-only, exercise-only, or combined intervention groups for a 12-week period; finally assessing if changes persist after stopping interventions.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve general lifestyle modifications such as dietary changes and physical activity. However, participants might experience muscle soreness from new exercises or digestive changes due to diet alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am obese, inactive, and at risk for type 2 diabetes but ready to commit to a 12-week exercise and diet program.
Select...
I am willing to follow a low-fat, low-calorie diet for 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in the sperm epigenome
Secondary outcome measures
Analyze persistent effects of diet and/or exercise
Correlate alterations in sperm epigenome with clinical and biochemical fitness biomarkers
Effects of Diet and Exercise Training on the Sperm Epigenome
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Exercise TrainingExperimental Treatment1 Intervention
≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity
Group II: Diet and exercise trainingExperimental Treatment2 Interventions
low fat/low caloric diet and ≥3 sessions with fitness trainer per week, for ≥30 min, at moderate to high intensity
Group III: DietExperimental Treatment1 Intervention
low fat/low caloric diet
Group IV: Normal/ActiveActive Control1 Intervention
No intervention
Group V: Obese/InactivePlacebo Group1 Intervention
Observational clinic visits

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,697 Total Patients Enrolled
2 Trials studying Men
520 Patients Enrolled for Men
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,776 Total Patients Enrolled
1 Trials studying Men
23,188 Patients Enrolled for Men
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,201 Total Patients Enrolled
1 Trials studying Men
100 Patients Enrolled for Men

Media Library

Diet Clinical Trial Eligibility Overview. Trial Name: NCT04175678 — N/A
Men Research Study Groups: Diet, Diet and exercise training, Exercise Training, Normal/Active, Obese/Inactive
Men Clinical Trial 2023: Diet Highlights & Side Effects. Trial Name: NCT04175678 — N/A
Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175678 — N/A
Men Patient Testimony for trial: Trial Name: NCT04175678 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially be a participant in this experiment?

"To meet the eligibility requirements of this medical trial, potential participants must be between 18 and 40 years old. The recruitment goal is to enroll around 100 individuals."

Answered by AI

What is the primary objective of this research trial?

"This longitudinal study, which is expected to last for five years, will focus on the epigenetic modifications of sperm. Additionally, it'll measure any changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), differentially methylated regions in healthy and obese men's sperm before and after 12 weeks of dietary or exercise intervention, as well as alterations in weight following said interventions."

Answered by AI

Is the research team currently recruiting participants for this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this scientific inquiry, which was first made public on March 1st 2020, is actively soliciting candidates for the trial. One medical facility needs to recruit approximately one-hundred individuals in order to complete the study."

Answered by AI

Does this study accept those aged 50 or above as participants?

"In order to be eligible for this particular trial, patients must fit the age range of 18-40. For those below or above that demographic, there are respectively 13 and 44 different clinical trials available."

Answered by AI

What is the enrolment capacity of this research project?

"Affirmative, clinicaltrials.gov's records indicate that this trial is currently seeking patients for enrollment. The first posting was on March 1st 2020 and the latest modification occurred August 18th 2022. Approximately 100 subjects need to be sourced from a single medica site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
The Lundquist Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Its close by and sounds interesting.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
2020. "Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175678.
~17 spots leftby Mar 2025
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