Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design
NCT ID: NCT04005456
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2018-09-01
2022-12-31
Brief Summary
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LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design.
Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention.
Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.
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Detailed Description
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There is a significant unmet need to identify the value of a personalized lifestyle intervention program for improving functional health outcomes. Whereas disease is well understood from traditional pathology-based indices, health is less easily defined. Historically, healthy has been the default term that is applied to an individual who is not recognized as having a disease. This definition of health as the absence of disease has resulted in the delivery of health and wellness as often lying outside the purview of medicine.
An evolving definition of health, however, is to recognize that it is related to the functional capacity of the individual. Functional capacity can be categorized in four assessment areas: physiological, physical, cognitive and emotional. All four of these subcategories are quantifiable by both qualitative and quantitative metrics. The effects on health of a multi-modal personalized lifestyle medicine intervention program can best be evaluated by using functional determinants.
Functional Medicine is an integrative medicine philosophy that uniquely incorporates 4P Medicine with a focus on function and dysfunction and the necessity to consider the physiological events that determine the balance between the two. The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants.
Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent. Due to the structure of the uniquely defined yet overlapping system of Umbrellas and Buckets, a specific Subject may participate consecutively and/or sequentially in a series of Umbrella and Buckets as applicable and their data may be included in multiple Umbrella and Bucket analyses.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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N of 1 Tent
Personalized dietary supplements, food plans, and behavioral change support program for a broad group (both an employee population and those recruited from practitioner practices) inclusive of all study Participants and specifically generally healthy individuals, those with established disease/conditions requiring a personalized approach, those with diseases/conditions currently with low prevalence in our study population and those women currently pregnant or breastfeeding.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Wellness Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of individuals characterized by minimal physical complaints and laboratory biomarkers of modest clinical significance.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Elevated Homocysteine Bucket
Personalized dietary supplements, food plans, and behavioral change support program for individuals from the Wellness Umbrella with elevated homocysteine level ≥ 10.4 µmol/L.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Dental Health Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of individuals with established dental disease.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Immune Health Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of individuals with autoimmune/inflammatory conditions (excluding metabolic disorders/atherosclerosis)
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Elevated Anti-Nuclear Antibodies (ANA) Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with elevated levels of antinuclear antibodies (preclinical symptomatology only).
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Autoimmune Conditions Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with an established diagnosis of an autoimmune conditions (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.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Symptomatic Fatigue/Myalgias Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a broad employee health group with symptoms of persistent fatigue and myalgias.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Gastrointestinal Health Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with conditions associated with issues of gastrointestinal health and of environmental toxicity or dysfunction related to detoxification of external toxins and internal metabolites.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Irritable Bowel Syndrome (IBS) Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with conditions associated with issues of gastrointestinal health.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Detoxification Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with conditions associated with issues of environmental toxicity or dysfunction related to detoxification of external toxins and internal metabolites.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Wellness Detoxification Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals characterized by minimal physical complaints and normal biomarkers.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Metabolic Health Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of participants classified as desirable weight with and without markers of dysglycemia/dyslipidemia or overweight/obese with and without markers of dysglycemia/dyslipidemia).
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Consequences of Metabolic (Dys)function Bucket C/S Design
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of participants classified as desirable weight with and without markers of dysglycemia/dyslipidemia or overweight/obese with and without markers of dysglycemia/dyslipidemia). C/S = crossover
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Consequences of Metabolic (Dys)function Bucket R/I Design
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of participants classified as desirable weight with markers of dysglycemia/dyslipidemia or overweight/obese with and without markers of dysglycemia/dyslipidemia). R/I = randomization/inclusion
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Ketogenic Product Development Exploratory Group
Subgroup investigation in participants (classified as desirable weight with and without markers of dysglycemia/dyslipidemia or overweight/obese with and without markers of dysglycemia/dyslipidemia) during their 8- or 12-week ketogenic program intervention phase
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Reproductive Health Umbrella
Personalized dietary supplements, food plans, and behavioral change support program for a group of participants with conditions associated with reproductive and hormonal health (including polycystic ovary syndrome, premenstrual syndrome, endometriosis, peri-menopause and menopausal conditions, women currently pregnant or breastfeeding, testosterone deficiency and andropause/late onset hypogonadism, and prostate health).
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Perimenopausal and Menopausal Transitions Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of women with conditions associated with reproductive and hormonal health specifically peri-menopause and menopausal conditions.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Premenstrual Syndrome Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of women with conditions associated with reproductive and hormonal health specifically premenstrual syndrome.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Polycystic Ovary Syndrome (PCOS) Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of women with PCOS with signs/symptoms/biomarkers of both metabolic dysfunction and hormonal derangements.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Andropause/Late Onset Hypogonadism Bucket
Personalized dietary supplements, food plans, and behavioral change support program for a group of men with conditions associated with reproductive and hormonal health specifically testosterone deficiency and andropause/late onset hypogonadism.
Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Interventions
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Supplements and/or medical foods
Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
Behavioral change support program
Program to implement lifestyle and behavioral change according to individuals' need.
Food plan
Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
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Wellness Umbrella:
* MOS SF-36 QN general score \< 60
Elevated Homocysteine Bucket:
* MOS SF-36 QN general score \< 60
Dental Health Umbrella:
* 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:
* 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:
* Any of the following: Fasting Blood Glucose ≥ 125mg/dl; HbA1c ≥ 6.5% and Blood Pressure ≥ 165/95 mm Hg.
Reproductive Health Umbrella:
18 Years
80 Years
ALL
Yes
Sponsors
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Tufts Medical Center
OTHER
MetaProteomics LLC
INDUSTRY
Metagenics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Lamb, MD
Role: PRINCIPAL_INVESTIGATOR
Personalized Lifestyle Medicine Center
Locations
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Personalized Lifestyle Medicine Center
Gig Harbor, Washington, United States
Countries
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Other Identifiers
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LIFEHOUSE-PLMC
Identifier Type: -
Identifier Source: org_study_id
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