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Symptomatic Fatigue/Myalgias Bucket for Gastrointestinal Dysfunction (LIFE-HOUSE Trial)
N/A
Waitlist Available
Led By Joseph Lamb, MD
Research Sponsored by Metagenics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at12 months
Awards & highlights
LIFE-HOUSE Trial Summary
This trial is designed to test the feasibility of this model.
Eligible Conditions
- Gastrointestinal Dysfunction
- Autoimmune Diseases
- Hormone Imbalance
- Dental Disease
- Well-being
- Cardiovascular Risk
- Neurocognitive Disorder
LIFE-HOUSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depression Anxiety, Stress Scale (DASS) questionnaire
Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
University of Rhode Island Change Assessment (URICA) questionnaire
Secondary outcome measures
25-hydroxy (OH) Vitamin D3
Anti-Nuclear Antibodies (ANA)
Beck Anxiety Inventory (BAI)
+15 moreLIFE-HOUSE Trial Design
21Treatment groups
Experimental Treatment
Group I: Wellness UmbrellaExperimental Treatment3 Interventions
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.
Group II: Wellness Detoxification BucketExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals characterized by minimal physical complaints and normal biomarkers.
Group III: Symptomatic Fatigue/Myalgias BucketExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a broad employee health group with symptoms of persistent fatigue and myalgias.
Group IV: Reproductive Health UmbrellaExperimental Treatment3 Interventions
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).
Group V: Premenstrual Syndrome BucketExperimental Treatment3 Interventions
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.
Group VI: Polycystic Ovary Syndrome (PCOS) BucketExperimental Treatment3 Interventions
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.
Group VII: Perimenopausal and Menopausal Transitions BucketExperimental Treatment3 Interventions
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.
Group VIII: N of 1 TentExperimental Treatment3 Interventions
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.
Group IX: Metabolic Health UmbrellaExperimental Treatment3 Interventions
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).
Group X: Ketogenic Product Development Exploratory GroupExperimental Treatment3 Interventions
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
Group XI: Irritable Bowel Syndrome (IBS) BucketExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with conditions associated with issues of gastrointestinal health.
Group XII: Immune Health UmbrellaExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of individuals with autoimmune/inflammatory conditions (excluding metabolic disorders/atherosclerosis)
Group XIII: Gastrointestinal Health UmbrellaExperimental Treatment3 Interventions
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.
Group XIV: Elevated Homocysteine BucketExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for individuals from the Wellness Umbrella with elevated homocysteine level ≥ 10.4 µmol/L.
Group XV: Elevated Anti-Nuclear Antibodies (ANA) BucketExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a group of individuals with elevated levels of antinuclear antibodies (preclinical symptomatology only).
Group XVI: Detoxification BucketExperimental Treatment3 Interventions
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.
Group XVII: Dental Health UmbrellaExperimental Treatment3 Interventions
Personalized dietary supplements, food plans, and behavioral change support program for a broad group of individuals with established dental disease.
Group XVIII: Consequences of Metabolic (Dys)function Bucket R/I DesignExperimental Treatment3 Interventions
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
Group XIX: Consequences of Metabolic (Dys)function Bucket C/S DesignExperimental Treatment3 Interventions
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
Group XX: Autoimmune Conditions BucketExperimental Treatment3 Interventions
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.
Group XXI: Andropause/Late Onset Hypogonadism BucketExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral change support program
2018
N/A
~400
Supplements and/or medical foods
2018
N/A
~400
Find a Location
Who is running the clinical trial?
Metagenics, Inc.Lead Sponsor
14 Previous Clinical Trials
1,016 Total Patients Enrolled
1 Trials studying Gastrointestinal Dysfunction
400 Patients Enrolled for Gastrointestinal Dysfunction
MetaProteomics LLCIndustry Sponsor
6 Previous Clinical Trials
651 Total Patients Enrolled
1 Trials studying Gastrointestinal Dysfunction
400 Patients Enrolled for Gastrointestinal Dysfunction
Tufts Medical CenterOTHER
252 Previous Clinical Trials
252,598 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women with premenstrual syndrome or hormonal imbalances will be excluded.Both men and women can participate.People with various autoimmune and inflammatory conditions can participate in this study.You have dental problems like bleeding gums, receding gum lines, or multiple untreated cavities. You also experience pain in your teeth or mouth, and have chronic sores in the mouth.You have a body mass index (BMI) between 18.5 and 40. You also have at least two of the following: high blood sugar, insulin resistance, high hemoglobin A1c levels, high triglyceride levels, high LDL particle number, high lipoprotein levels, low HDL levels, and high blood pressure.You have a body mass index (BMI) between 18.5 and 40. You also have at least two of the following: high glucose levels, insulin resistance, high HbA1c, high triglycerides, high LDL particle number, high lipoprotein (a), low HDL levels, and high blood pressure.For women, you have certain conditions that affect your breasts or reproductive health. For men, you have testosterone deficiency, prostate health concerns, or late onset hypogonadism.You are a woman experiencing symptoms related to menopause.You have symptoms, lab results or diagnosis of an autoimmune, inflammatory condition or other unexplained conditions that cause fatigue and muscle pain.You have symptoms, lab results, or diagnosis that suggest Irritable Bowel Syndrome or other gastrointestinal issues (excluding Inflammatory Bowel Disease), and have challenges with healthy detoxification.Your overall rating on a general health questionnaire (MOS SF-36 QN) is lower than 60.You have a medical condition that causes inflammation or autoimmune response, but not related to metabolic disorders or atherosclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Symptomatic Fatigue/Myalgias Bucket
- Group 2: Gastrointestinal Health Umbrella
- Group 3: Irritable Bowel Syndrome (IBS) Bucket
- Group 4: Immune Health Umbrella
- Group 5: Detoxification Bucket
- Group 6: Metabolic Health Umbrella
- Group 7: Perimenopausal and Menopausal Transitions Bucket
- Group 8: Premenstrual Syndrome Bucket
- Group 9: N of 1 Tent
- Group 10: Polycystic Ovary Syndrome (PCOS) Bucket
- Group 11: Elevated Homocysteine Bucket
- Group 12: Dental Health Umbrella
- Group 13: Andropause/Late Onset Hypogonadism Bucket
- Group 14: Wellness Umbrella
- Group 15: Elevated Anti-Nuclear Antibodies (ANA) Bucket
- Group 16: Autoimmune Conditions Bucket
- Group 17: Wellness Detoxification Bucket
- Group 18: Consequences of Metabolic (Dys)function Bucket C/S Design
- Group 19: Consequences of Metabolic (Dys)function Bucket R/I Design
- Group 20: Ketogenic Product Development Exploratory Group
- Group 21: Reproductive Health Umbrella
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prerequisites must potential participants meet to be accepted into this experiment?
"This clinical trial is searching for 400 individuals with autoimmune diseases, aged 18 to 80."
Answered by AI
Are new participants still being welcomed into this experiment?
"According to clinicaltrials.gov, this specific trial is no longer actively recruiting participants as it was last edited on April 4th 2022 and initially posted on September 1st 2018. Nonetheless, there are still 768 other trials that have open enrolment at the present time."
Answered by AI
Can individuals of less than octogenarian age participate in this experiment?
"In compliance with study parameters, the minimum age for enrolment is 18 years old and the maximum allowable age being 80."
Answered by AI
What are the desired outcomes of this experiment?
"As reported by Metagenics, Inc., the primary objective of this study will be evaluated over a Change from baseline period at 12 months using the University of Rhode island Change Assessment (URICA) questionnaire. Secondary outcomes that are also being assessed include Waist to Hip Ratio (WHR), which is provided as a numerical 0.00 value and denotes potential major health risk; Waist Circumference (WC) in centimeters (cm); and Height in meter (m)."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Personalized Lifestyle Medicine Center
What portion of applicants met pre-screening criteria?
Met criteria
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