Personalized lifestyle intervention for improving functional health outcomes using n-of-1 tent-umbrella-bucket design

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2019
General Inclusion Criteria for 'N of 1' Tent: ‐ male or female ‐ ages 18‐80, inclusive ‐ willing to give written informed consent to participate in the study General Exclusion Criteria for 'M of 1' Tent: ‐ Medical History and Concurrent Diseases: ‐ A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or hematologic disease. ‐ Known infection with HIV, TB or Hepatitis B or C. ‐ Inability to comply with study and/or follow‐up visits. ‐ Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance. ‐ Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance. The following describes specific inclusion and/or exclusion criteria applicable to individual study arms. Wellness Umbrella: Specific Exclusion Criteria: ‐ MOS SF‐36 QN general score < 60 Elevated Homocysteine Bucket: Specific Inclusion Criteria: ‐ Elevated Homocysteine Level = 10.4 µmol/L Specific Exclusion Criteria: ‐ MOS SF‐36 QN general score < 60 Dental Health Umbrella: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ General Inclusion Criteria for Autoimmune and Inflammatory Conditions Umbrella ‐ Elevated ANA Level > 1:40 titer (A specified sub‐group for analysis will be all with two baseline elevated ANA Level > 1:40 titer.) Specific Exclusion Criteria: ‐ Symptoms, signs, laboratory biomarkers (excluding ANA) or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis) Autoimmune Conditions Bucket: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ 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: Specific Inclusion Criteria: ‐ Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification Wellness Detoxification Bucket: Specific Inclusion Criteria: ‐ Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification Metabolic Health Umbrella: Specific Inclusion Criteria: ‐ BMI>= 18.5 and <40 Consequences of Metabolic Function/Dysfunction Bucket ‐ Crossover Design: Specific Inclusion Criteria: ‐ 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. Specific Exclusion Criteria: ‐ Any of the following: Fasting Blood Glucose = 125mg/dl; HbA1c = 6.5% and Blood Pressure = 165/95 mm Hg. Consequences of Metabolic Function/Dysfunction Bucket ‐ Randomization/Inclusion Design: Specific Inclusion Criteria: ‐ 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 Health, Subjective;Gastrointestinal Dysfunction;Cardiovascular Risk Factor;Autoimmune Diseases;Dental Diseases;Hormone Disturbance;Neurocognitive Dysfunction Other: Food plan;Behavioral: Behavioral change support program;Dietary Supplement: Supplements and/or medical foods Depression Anxiety, Stress Scale (DASS) questionnaire;University of Rhode Island Change Assessment (URICA) questionnaire;Medical Outcomes Study Short Form 36 (MOS SF‐36) questionnaire Patient‐Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF);Patient‐Reported Outcomes Measurement Information System (PROMIS) Anxiety Test;Patient‐Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test;Beck Anxiety Inventory (BAI);Beck Depression Inventory (BDI);Omega‐3 Fatty Acids;Homocysteine;High sensitivity C‐Reactive Protein (Hs‐CRP);25‐hydroxy (OH) Vitamin D3;Anti‐Nuclear Antibodies (ANA);Total Cholesterol;Glucose;Weight;Height;Waist to Hip Ratio (WHR);Hip Circumference (HC);Waist Circumference (WC);Body Mass Index (BMI)
Epistemonikos ID: 439f24b38d1df41ef164f4d492f463ac0046c9cf
First added on: Nov 24, 2021