Clinical trial NCT04005456: Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design
Official title: LIFE-HOUSE: A Lifestyle Intervention and Functional Evaluation - a Health Outcomes Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Gastrointestinal Dysfunction
Cardiovascular Risk Factor
Autoimmune Diseases
Dental Diseases
Hormone Disturbance
Neurocognitive Dysfunction
Keywords: wellness
n-of-1 trial
detoxification
personalized medicine
functional medicine
4P medicine
lifestyle medicine
homocysteine
dietary supplement
medical food
behavioral change
lifestyle modification
employee wellness program
functional capacity
food plan
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
name: MetaProteomics LLC
First posted: 2019-07-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Detailed description: It has been suggested that the best medicine should value four principles (4P) - medicine should be personalized, predictive, preventative and participatory. This 4P Medicine will thus be personalized and patient centered with a focus on the person who has the disease and not the disease the person has. It will be predictive as it identifies the pre-clinical trend/decline towards illness sooner than onset of symptoms that herald the loss of function and health. It will be preventative as the information gathered should offer opportunities to modify these trajectories towards illness and finally it will be participatory as individuals will be intimately involved in the gathering of data to identify trends and in the application of lifestyle measures to improve their lives.

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.

Eligibility criteria: 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.

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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 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.

Reproductive Health Umbrella:

Specific Inclusion Criteria:

* 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:

Specific Inclusion Criteria:

* Female with signs/symptoms consistent with a clinical diagnosis of peri-menopause and menopausal conditions.

Premenstrual Syndrome Bucket:

Specific Inclusion Criteria:

* Female with a diagnosis of premenstrual syndrome and/or signs/symptoms/biomarkers consistent with estrogen/progesterone imbalances.

PCOS Bucket:

Specific Inclusion Criteria:

* Female with signs/symptoms/biomarkers consistent with a clinical diagnosis of PCOS.

Andropause/Late Onset Hypogonadism Bucket:

Specific Inclusion Criteria:

* Male with signs/symptoms/biomarkers consistent with a clinical diagnosis of Andropause/Late Onset Hypogonadism.

Primary outcomes:
measure: Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
timeFrame: Change from baseline at 12 months
measure: University of Rhode Island Change Assessment (URICA) questionnaire
timeFrame: Change from baseline at 12 months
measure: Depression Anxiety, Stress Scale (DASS) questionnaire
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Change from baseline at 12 months
measure: Waist Circumference (WC)
timeFrame: Change from baseline at 12 months
measure: Hip Circumference (HC)
timeFrame: Change from baseline at12 months
measure: Waist to Hip Ratio (WHR)
timeFrame: Change from baseline at 12 months
measure: Height
timeFrame: Change from baseline at 12 months
measure: Weight
timeFrame: Change from baseline at12 months
measure: Glucose
timeFrame: Change from baseline at 12 months
measure: Total Cholesterol
timeFrame: Change from baseline at 12 months
measure: Anti-Nuclear Antibodies (ANA)
timeFrame: Change from baseline at 12 months
measure: 25-hydroxy (OH) Vitamin D3
timeFrame: Change from baseline at 12 months
measure: High sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: Change from baseline at 12 months
measure: Homocysteine
timeFrame: Change from baseline at 12 months
measure: Omega-3 Fatty Acids
timeFrame: Change from baseline at 12 months
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline at 12 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline at12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test
timeFrame: Change from baseline at 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Test
timeFrame: Change from baseline at12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF)
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Personalized Lifestyle Medicine Center
state: Washington
Study officials:
affiliation: Personalized Lifestyle Medicine Center
name: Joseph Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: