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Methylation Diet and Lifestyle Program for Healthy Subjects (MDL Trial)

N/A

Waitlist Available

Research Sponsored by National University of Natural Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males, ages 50-72

Be older than 18 years old

Must not have

Currently taking any of the following prescription medications: Proton pump inhibitors: omeprazole (Prilosec, Prilosec OTC); aspirin and omeprazole (Yosprala); lansoprazole (Prevacid, Prevacid IV, Prevacid 24-Hour); ;dexlansoprazole (Dexilent, Dexilent Solutab); rabeprazole (Aciphex, Aciphex Sprinkle); pantoprazole (Protonix), H2-blockers: nizatidine (Axid, Axid AR, Axid Pulvules); famotidine (Pepcid, Pepcid AC); cimetidine (Tagamet, Tagamet HB); ranitidine (Zantac)

Have a diagnosis of cardiovascular disease, kidney disease, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer (does not include basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at the effects of a 9-week diet and lifestyle intervention on quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males.

Who is the study for?

This study is for healthy English-speaking men aged 50-72 who are willing to follow a specific diet and lifestyle program for 9 weeks. Participants must be able to use electronic devices, avoid certain over-the-counter products, track their daily food intake, sleep, stress management techniques, exercise, and take part in blood and saliva sampling.

What is being tested?

The trial tests the impact of a 9-week diet and lifestyle intervention on quality of life and DNA methylation-related biomarkers. It includes dietary changes, exercise routines, stress management practices along with consuming a tropical fruit-flavored nutrient beverage called PhytoGanix and taking UltraFlora Intensive Care probiotics.

What are the potential side effects?

Since this trial involves dietary supplements (PhytoGanix & UltraFlora Intensive Care) alongside lifestyle modifications rather than drugs or invasive procedures, side effects may be minimal but could include digestive discomfort or allergic reactions to supplement ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged between 50 and 72.

Exclusion Criteria

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

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I am currently taking medication for stomach acid.

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I have been diagnosed with a major health condition like heart, kidney, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer.

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I use over-the-counter nutrition supplements or herbal products.

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I have been diagnosed with a neurodegenerative condition like ALS, Parkinson's, MS, or Alzheimer's.

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I have not used nicotine, marijuana, CBD, or recreational drugs in the last 30 days.

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I have been diagnosed with an immunodeficiency condition like HIV/AIDS.

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I am currently getting nutrients through an IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

Secondary study objectives

Measure Yourself Medical Outcome Profile (MYMOP)

National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire

Other study objectives

DNA Methylation Pathway Profile by Doctor's Data

Folate Vitamer Panel by Doctor's Data

Infinium Methylation EPIC Index by Illumina

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment6 Interventions

The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses.

Group II: Control GroupActive Control1 Intervention

The control group will undergo the same testing measures as the intervention group, but will not have access to the education information or be instructed to change diet or lifestyle factors. They will have access to the information after the study is complete.

0 / 8Eligibility criteria met