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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)

Must not have

Men not living in the catchment's area of the clinic or within a reasonable distance from the site

History of hypertension, including hypertension controlled with treatment in the healthy, active group

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

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

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I am obese, inactive, and at risk for type 2 diabetes but ready to commit to a 12-week exercise and diet program.

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I am willing to follow a low-fat, low-calorie diet for 12 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I live too far from the clinic to participate.

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I have high blood pressure, but it's controlled with medication.

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I have not been in another clinical trial in the last 30 days.

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I have a history of reproductive issues, such as vasectomy or infertility.

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I have severe digestive issues that prevent me from following specific diets.

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I have heart, lung, or joint issues that prevent me from doing moderate exercise.

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I have had cancer before, but it was only non-melanoma skin cancer and it was treated.

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I have a history of heart, kidney, liver, or lung disease.

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I have a serious condition like diabetes or am significantly overweight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,988 Previous Clinical Trials

2,683,423 Total Patients Enrolled

2 Trials studying Men

520 Patients Enrolled for Men

National Institutes of Health (NIH)NIH

2,736 Previous Clinical Trials

7,507,850 Total Patients Enrolled

1 Trials studying Men

3,642 Patients Enrolled for Men

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor

103 Previous Clinical Trials

46,373 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

~12 spots leftby Mar 2025

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