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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
MDL Trial 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.Check my eligibility
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.See study design
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.
MDL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 50 and 72.
MDL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
Secondary outcome measures
Measure Yourself Medical Outcome Profile (MYMOP)
National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire
Other outcome measures
DNA Methylation Pathway Profile by Doctor's Data
Folate Vitamer Panel by Doctor's Data
Infinium Methylation EPIC Index by Illumina
+2 moreMDL 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.
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Who is running the clinical trial?
National University of Natural MedicineLead Sponsor
29 Previous Clinical Trials
1,283 Total Patients Enrolled
Dr. Kara Fitzgerald, NDUNKNOWN
Metagenics, Inc.Industry Sponsor
14 Previous Clinical Trials
1,372 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for stomach acid.I have been diagnosed with a major health condition like heart, kidney, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer.I agree not to take any over-the-counter meds, supplements, or herbal products during the study.This person is willing to track their food intake, sleep, stress management techniques, and exercise every day.You drink too much alcohol (more than 4 drinks per day or 14 per week on average).to help science
Some people are willing to provide saliva samples to help science.I use over-the-counter nutrition supplements or herbal products.I have been diagnosed with a neurodegenerative condition like ALS, Parkinson's, MS, or Alzheimer's.You are allergic to any of the ingredients in the study supplements or the recommended dietary therapy.I have not used nicotine, marijuana, CBD, or recreational drugs in the last 30 days.You started a new exercise routine or made significant changes to your current routine within the last month.Be willing to follow a nine-week diet and lifestyle program that includes specific nutrition and exercise guidelines.I am willing to drink a special beverage and take a probiotic capsule every day.I have been diagnosed with an immunodeficiency condition like HIV/AIDS.I am currently getting nutrients through an IV.I am a man aged between 50 and 72.I am willing to fast for 10-12 hours and have my blood drawn three times.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment permit individuals aged 25 or above to participate?
"This clinical trial is targeting adult patients aged between 50 and 72. For those under 18, there are 53 trials available while the elderly have access to 394 different medical studies."
Answered by AI
Is enrollment still open for participants of this research experiment?
"According to the clinicaltrials.gov record, this research has already completed its recruitment phase and is no longer open for enrolment. The study's initial posting was on February 1st 2018 with a final update on August 26th 2021. However, there are 869 other trials actively searching for participants at present."
Answered by AI
Is it feasible for me to be part of this experimental program?
"Patients between the ages of 50 and 72 that adhere to a healthy lifestyle are eligible for this trial, which is presently recruiting roughly 44 participants."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
NUNM Helfgott Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
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