Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design

Inclusion Criteria

• •male or female
• •ages 18-80, inclusive
• •willing to give written informed consent to participate in the study
• •Elevated Homocysteine Level ≥ 10.4 µmol/L
• •Participants with extensive gingivitis/periodontitis/Caries/Painful teeth/Fractured Teeth. Identification of any of the following on physical exam: gingivitis, receding gumlines, periodontitis, fractured teeth, multiple unrestored caries. Identification on history of bleeding gums, bleeding while flossing, bleeding when brushing, chronic sores in the mouth, painful teeth, pain when biting on aluminum foil.
• •Neurological Health Umbrella:
• •Elevated score on any subscale of Depression Anxiety Stress Scale (DASS) QN; and/or a score demonstrating mild or moderate depression or anxiety on Beck Depression Score and Beck Anxiety Score; and/or a MOS SF-36 subscale Emotional Role Functioning or Mental Health \< 50; and/or PROMIS Cognitive Function QN score \< 50.
• •Autoimmune and Inflammatory Conditions Umbrella:
• •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis) and ill-defined conditions characterized by symptomatic fatigue/myalgias.
• •Elevated ANA Bucket:
• •Elevated ANA Level \> 1:40 titer (A specified sub-group for analysis will be all with two baseline elevated ANA Level \> 1:40 titer.)
• •Established Diagnosis of an autoimmune condition (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Bowel Disease and Hashimoto's Thyroiditis) with ANA level \>1:80 titer, rheumatoid factor (RF) ≥ 14 IU/ml, fecal calprotectin ≥ 50 mcg/g and thyroid autoantibody levels specifically thyroglobulin antibodies ≥ 115 IU/ml and/or thyroid peroxidase antibodies ≥ 35 IU/ml.
• •Symptomatic Fatigue and Myalgia Bucket:
• •Two of the following five features have been generally present for at least 3 months:
• •* Widespread bodily pain (pain in 3 of 5 regions (Left upper, right upper, left lower, right lower, axial) with and without symptomatic trigger points
• •* Generalized fatigue
• •* Sleep disturbances including awakening unrefreshed
• •* Cognitive (memory or thought) problems
• •* Post-exertional malaise
• •Gastrointestinal Health Umbrella:
• •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease) as well as physiological challenges with healthy detoxification
• •IBS Bucket:
• •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease)
• •Detoxification Bucket:
• •Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
• •Wellness Detoxification Bucket:
• •Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
• •Metabolic Health Umbrella:
• •BMI\>= 18.5 and \<40
• •Consequences of Metabolic Function/Dysfunction Bucket - Crossover Design:
• •BMI\>= 18.5 and \<40
• •Metabolic Dysfunction is defined as having at least two of the following: Glucose ≥ 100 mg/dl; Homeostatic Model of Assessment for Insulin Resistance (HOMA-IR) (Glucose \[mg/dl\]Insulin \[µiu/L)/405), score ≥ 2.0; HbA1c ≥ 5.7%; Triglycerides ≥ 100 mg/dl; Low Density Lipoprotein Particle Number (LDLp) \>1000, lipoprotein (a) (lp(a)) \> 30 mg/dl ; HDL (women) ≤ 50 ng/ml; HDL (men) ≤ 40 ng/ml; and blood pressure ≥ 135/85 mm Hg.
• •BMI\>= 18.5 and \<40
• •Metabolic Dysfunction is defined as having at least two of the following: Glucose ≥ 100 mg/dl; Homeostatic Model of Assessment for Insulin Resistance (HOMA-IR) (Glucose \[mg/dl\]Insulin \[µiu/L)/405), score ≥ 2.0; HbA1c ≥ 5.7%; Triglycerides ≥ 100 mg/dl; Low Density Lipoprotein Particle Number (LDLp) \>1000, lipoprotein (a) (lp(a)) \> 30 mg/dl; HDL (women) ≤ 50 ng/ml; HDL (men) ≤ 40 ng/ml; and blood pressure ≥ 135/85 mm Hg
• •Applicable to female Participants: a clinical diagnosis of fibrocystic breast and/or increased risk for Breast cancer, polycystic ovary syndrome, endometriosis, premenstrual syndrome, peri-menopause and menopausal conditions.
• •Applicable to male Participants: a diagnosis of testosterone deficiency and andropause/late onset hypogonadism or prostate health concerns.
• •Perimenopausal and Menopausal Transitions Bucket:
• •Female with signs/symptoms consistent with a clinical diagnosis of peri-menopause and menopausal conditions.
• •Premenstrual Syndrome Bucket:
• •Female with a diagnosis of premenstrual syndrome and/or signs/symptoms/biomarkers consistent with estrogen/progesterone imbalances.
• •PCOS Bucket:
• •Female with signs/symptoms/biomarkers consistent with a clinical diagnosis of PCOS.
• •Andropause/Late Onset Hypogonadism Bucket:
• •Male with signs/symptoms/biomarkers consistent with a clinical diagnosis of Andropause/Late Onset Hypogonadism.