Methylation Diet and Lifestyle Study (MDL)
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|ClinicalTrials.gov Identifier: NCT03472820|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lifestyle Diet Healthy||Other: Diet Recommendations Other: Lifestyle Recommendations Other: Exercise Recommendations Other: Stress Management Recommendations Other: PhytoGanix (tropical fruit flavor) Other: UltraFlora Intensive Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||April 1, 2019|
Experimental: Intervention Group
The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses.
Other: Diet Recommendations
Specific dietary guidelines will be outlined for participants.
Other: Lifestyle Recommendations
Participants are encouraged to average a minimum of 7 hours of sleep per night.
Other: Exercise Recommendations
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.
Other: Stress Management Recommendations
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.
Other: 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: UltraFlora Intensive Care
Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.
No Intervention: Control Group
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.
- 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.
- Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: 8 weeks ]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.
- National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire [ Time Frame: 8 weeks ]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.
- Infinium Methylation EPIC Index by Illumina [ Time Frame: 8 weeks ]Infinium Methylation EPIC Index by Illumina measures the methylation status of CpG sites. Epigenetic profile that assesses methylation on over 850,000 CpG DNA sites. A saliva sample will collect approximately 2 mL (~1 teaspoon) into a cryovial.
- Methylation Profile by Doctor's Data [ Time Frame: 8 weeks ]Methylation Profile by Doctor's Data measures the changes in the methylation related biomarkers and is a functional assessment of the phenotypic expression of common single nucleotide polymorphisms (SNPs) and provides a "methylation index," a ratio of S-Adenosylmethionine (SAM) to S-Adenosylhomocysteine (SAH).
- Folate Vitamer Panel by Doctor's Data [ Time Frame: 8 weeks ]Folate Vitamer Panel by Doctor's Data measures the changes in the methylation related biomarkers and measures folate congeners affecting enzyme function in methylation pathways including unmodified Folic Acid (UMFA), 5-Methyltetrahydrofolate (5-MTHF), tetrahydrofolate (THF), folinic Acid (5-CHO-THF).
- Medical Symptom Questionnaire (MSQ) [ Time Frame: 8 weeks ]The MSQ measures change(s) in patient-reported symptoms and is a 71-question measure that measures various health areas including: Digestive tract, Eyes, Energy/Activity, Emotions, Head, Heart, Joint/Muscles, Lungs, Mind, Mouth/Throat, Nose, Skin, Weight, and Other.
- DNA Methylation Pathway Profile by Doctor's Data [ Time Frame: 8 weeks ]DNA Methylation Pathway Profile is a measurement of potential confounders and assesses changes to single nucleotide polymorphisms (SNPs) - DNA genotype which may affect enzymatic function which include, methionine metabolism, detoxification, hormones, and vitamin D. This is a blood spot test and requires collection of 5 drops of blood after a finger stick.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472820
|Contact: Ryan Bradley, ND, MPHfirstname.lastname@example.org|
|Contact: Kara Fitzgerald, NDemail@example.com|
|United States, Oregon|
|NUNM Helfgott Research Institute||Recruiting|
|Portland, Oregon, United States, 97201|
|Contact: Trina Soileau Research Coordinator 503-552-1746 firstname.lastname@example.org|
|Contact: Emily Stack Research Coordinator 503-552-1777 email@example.com|
|Principal Investigator: Ryan Bradley, ND, MPH|