Study Summary
This trial is designed to see if epigenetic programming in sperm changes in response to diet and exercise in obese, inactive men.
Eligible Conditions
- Men
- Healthy Lifestyle
- Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 19 Secondary · Reporting Duration: 5 years
12-48 weeks
Changes in BMI
Changes in HDL
Changes in HbA1c
Insulin Resistance
Changes in LDL
Changes in Triglycerides
Changes in VO2peak
Glucose
Changes in insulin
Changes in muscle torque
Changes in nutrient intake
Changes in plasma cholesterol
Changes in waist/hip ratio
Changes in weight
Comparing differential sperm epigenetic signals (DNA methylation)
Comparing differential sperm epigenetic signals (histone modifications)
Comparing differential sperm epigenetic signals (non-coding RNAs)
Correlate the alternations in sperm epigenome with clinical and biochemical and "fitness" biomarker
5 years
Changes in the sperm epigenome (DNA methylation)
Changes in the sperm epigenome (Histone modifications)
Changes in the sperm epigenome (non-coding RNAs)
Diet and Exercise Modulate the Sperm Epigenome in Men
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
Normal/Active
1 of 5
Diet
1 of 5
Diet and exercise training
1 of 5
Exercise Training
1 of 5
Obese/Inactive
1 of 5
Active Control
Experimental Treatment
Non-Treatment Group
100 Total Participants · 5 Treatment Groups
Primary Treatment: Exercise · Has Placebo Group · N/A
Diet
Other
Experimental Group · 1 Intervention: Diet · Intervention Types: OtherDiet and exercise trainingExperimental Group · 2 Interventions: Exercise, Diet · Intervention Types: Other, Other
Exercise Training
Other
Experimental Group · 1 Intervention: Exercise · Intervention Types: OtherNormal/Active
Other
ActiveComparator Group · 1 Intervention: Standard care · Intervention Types: OtherObese/Inactive
Other
PlaceboComparator Group · 1 Intervention: Standard care · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,178 Total Patients Enrolled
1 Trials studying Men
23,188 Patients Enrolled for Men
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
96 Previous Clinical Trials
31,765 Total Patients Enrolled
1 Trials studying Men
100 Patients Enrolled for Men
Christina Wang, MDPrincipal InvestigatorThe Lundquist Institute
8 Previous Clinical Trials
523 Total Patients Enrolled
Eligibility Criteria
Age 18 - 40 · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a fasting lipid panel within reference range or not clinically significant above the reference ranges.
You participate in ≤150 min/week of moderate intensity physical activity.
Consume at least 30% of your calories from fat.
You participate in ≥150 min/week of moderate intensity physical activity as assessed by accelerometer.
Consume less than 30% of calories as fat/day.
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Conditions
Cancer Related
Treatments