LifestyleMDLNCT03472820
Methylation Diet and Lifestyle Study
A study testing Diet Recommendations, Lifestyle Recommendations and Exercise Recommendations in people with Lifestyle and Diet, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Read more about this study
- Who is it for?
- Ages 50 to 72 years, men onlyHealthy volunteers can take part
- What is being tested?
- Diet Recommendations, Lifestyle Recommendations and Exercise Recommendations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 72 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Males, ages 50-72
- Willing to adhere to 9 weeks of a dietary and lifestyle program including specific nutrition and exercise guidelines
- Willing to avoid any over-the-counter medications, supplements or herbal products for the length of the study, except short-term use (<1 week) use at least 1 week before scheduled study visits
- Willing to have blood drawn three times and abstain from food or beverage intake for 10-12 hours before blood draws
- Willing to provide saliva samples
- Willing to track food intake, sleep, stress management techniques, and exercise daily
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- Willing to drink a nutrient-enriched beverage and take a encapsulated probiotic daily
- Willing and able to use electronic devices and connect to the internet
- Able to speak, read and understand English
Who cannot join
- • 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)
- These classes of medications are excluded due to direct (due to nutrient requirements for metabolism) and indirect (through impaired digestion and assimilation of nutrients).
- Use of nutrition supplements or herbal products not prescribed by a licensed healthcare provider for a medical condition
- Currently following a prescribed dietary/lifestyle program or initiate within the 30 days prior to baseline
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- Initiation of or changes to an exercise regimen within 30 days prior to baseline
- Use of nicotine, marijuana or cannabinoids (including CBD products) or recreational drugs/substances (such as but not limited to cocaine, phencyclidine [PCP], and methamphetamine) current/within the last 30 days or use during the study
- 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).
- Have a diagnosis of an immunodeficiency condition, such as Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
- Have a diagnosis of neurodegenerative conditions such as, amyotrophic lateral sclerosis (ALS), Parkinson's disease, Multiple Sclerosis, or Alzheimer's disease.
- Excessive alcohol consumption (more than 4 drinks per day or 14 per week on average)
- Known sensitivity, intolerance or allergy to ingredients in the study supplements or in the recommended dietary therapy
- Currently receiving intravenous nutrient therapy
- Currently participating in another interventional research study or participated in another interventional study within the last 3 weeks prior to baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
NUNM Helfgott Research Institute
Portland, Oregon, 97201
About this study
Official title: The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.
The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Environmental factors have been shown to influence, sometimes rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process, playing a key role in phenotypic expression of health and disease.
DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition or expression of certain genes and has been associated with the pathogenesis of numerous conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity, diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others. Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably influence DNA methylation patterns.
Read more
Understanding that environmental factors can potently and sometimes rapidly, favorably or negatively influence epigenetic expression, a short-term diet and lifestyle intervention may significantly augment DNA methylation expression.
The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on patient-reported quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males ages 50-72.
- Being tested
- Diet Recommendations, Lifestyle Recommendations, Exercise Recommendations, Stress Management Recommendations, PhytoGanix (tropical fruit flavor)
- Keywords
- Diet, Lifestyle, DNA methylation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet RecommendationsOther
Specific dietary guidelines will be outlined for participants.
Lifestyle RecommendationsOther
Participants are encouraged to average a minimum of 7 hours of sleep per night.
Exercise RecommendationsOther
Participants will be encouraged to exercise a minimum of 30 minutes at least 5 days per week at an intensity of 60-80% of maximum perceived exertion.
Stress Management RecommendationsOther
Participants will utilize the Cleveland Clinic's Stress Free Now application to engage in a variety of guided stress reduction techniques, including meditation and mindful breathing. Recommended frequency is twice daily, preferably morning and evening.
PhytoGanix (tropical fruit flavor)Other
Organic Superfruits \& Greens Powder Drink Mix is a food-based phytonutrient blend. Participants will take 2 servings daily in divided doses.
UltraFlora Intensive CareOther
Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses. Receives: Other: Diet Recommendations; Other: Lifestyle Recommendations; Other: Exercise Recommendations; Other: Stress Management Recommendations; Other: PhytoGanix (tropical fruit flavor); Other: UltraFlora Intensive Care |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety.
Measured: 8 weeks
Secondary outcomes (2)
Measure Yourself Medical Outcome Profile (MYMOP)
MYMOP will measure change(s) in patient-reported symptoms and is a patient-centered outcome measure that allows for the participant to self-select their top health concern(s) or symptom(s) they are dealing with in their own words. The participant can also choose an activity that is limited by that health concern.
Measured: 8 weeks
National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire
The NUNM Multi-system Symptom/Adverse Event Questionnaire measures change(s) in patient-reported symptoms and is a standardized ninety-one point monitoring form that requires asking questions pertaining to the following organ systems: eyes/ears/nose/throat, gastrointestinal, neurological/ musculoskeletal, psychological/general, cardiopulmonary, skin, genitourinary and whole body systems.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Kara Fitzgerald, ND, Metagenics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472820
- Sponsor's protocol ID
- RB100217
- Acronym
- MDL
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2018
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Villanueva JL, Vita AA, Zwickey H, Fitzgerald K, Hodges R, Zimmerman B, Bradley R. Dietary associations with reduced epigenetic age: a secondary data analysis of the methylation diet and lifestyle study. Aging (Albany NY). 2025 Apr 17;17(4):994-1010. doi: 10.18632/aging.206240. Epub 2025 Apr 17.
PubMed 40266024
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.
- ClinicalTrials.gov ID
- NCT03472820
- Acronym / sponsor ID
- MDL / RB100217
- Keywords
- Diet, Lifestyle, DNA methylation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Dr. Kara Fitzgerald, ND, Metagenics, Inc.
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Environmental factors have been shown to influence, sometimes rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process, playing a key role in phenotypic expression of health and disease.
DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition or expression of certain genes and has been associated with the pathogenesis of numerous conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity, diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others. Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably influence DNA methylation patterns.
Understanding that environmental factors can potently and sometimes rapidly, favorably or negatively influence epigenetic expression, a short-term diet and lifestyle intervention may significantly augment DNA methylation expression.
The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on patient-reported quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males ages 50-72.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Diet Recommendations, Other: Lifestyle Recommendations, Other: Exercise Recommendations, Other: Stress Management Recommendations, Other: PhytoGanix (tropical fruit flavor), Other: UltraFlora Intensive CareThe intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses. |
| Control Group | No 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. |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Males, ages 50-72
Key exclusion criteria (15 listed)
- • Currently taking any of the following prescription medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet RecommendationsSpecific dietary guidelines will be outlined for participants. | Other | Intervention Group |
| Lifestyle RecommendationsParticipants are encouraged to average a minimum of 7 hours of sleep per night. | Other | Intervention Group |
| Exercise RecommendationsParticipants will be encouraged to exercise a minimum of 30 minutes at least 5 days per week at an intensity of 60-80% of maximum perceived exertion. | Other | Intervention Group |
| Stress Management RecommendationsParticipants will utilize the Cleveland Clinic's Stress Free Now application to engage in a variety of guided stress reduction techniques, including meditation and mindful breathing. Recommended frequency is twice daily, preferably morning and evening. | Other | Intervention Group |
| PhytoGanix (tropical fruit flavor)Organic Superfruits \& Greens Powder Drink Mix is a food-based phytonutrient blend. Participants will take 2 servings daily in divided doses. | Other | Intervention Group |
| UltraFlora Intensive CareProbiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses. | Other | Intervention Group |
Primary outcome
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 8 weeks
PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety.
2 secondary outcomes
Measure Yourself Medical Outcome Profile (MYMOP)
Time frame: 8 weeks
National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 40266024Villanueva JL, Vita AA, Zwickey H, Fitzgerald K, Hodges R, Zimmerman B, Bradley R. Dietary associations with reduced epigenetic age: a secondary data analysis of the methylation diet and lifestyle study. Aging (Albany NY). 2025 Apr 17;17(4):994-1010. doi: 10.18632/aging.206240. Epub 2025 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Recommendations, Lifestyle Recommendations and Exercise Recommendations in people with Lifestyle and Diet, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.