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There was no significant difference between placebo and control.
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This is a decentralized, double-blind, randomized, placebo-controlled study to assess the effectiveness of different dietary supplements in decreasing systemic chronic inflammation (SCI) and lowering inflammatory age (iAge®). iAge® is a metric for age-related chronic inflammation and immune function decline calculated from a standard blood draw utilizing immune phenotyping and artificial intelligence algorithms. SCI is a natural process that occurs within the body. It is believed to accelerate the process of biological aging. As opposed to acute inflammation, iAge® is not a reflection of illness, infection, trauma or injury. It naturally occurs in the ambulatory healthy population as we age as a function of the body.
This study will use immunotype specific dietary supplement formulations to improve a participant's Inflammatory Age® (iAge®).
This decentralized, double-blind, randomized, placebo-controlled study will identify interventions that may lower a participant's inflammatory age (iAge®) and will increase the number of participants with objective and subjective health information that have associated iAge® scores. The study will also (1) correlate secondary endpoints with baseline and subsequent iAge® scores, (2) confirm the compatibility of the iAge® test with the Tasso device, ADX100 or ViveBio home blood collection systems, and (3) confirm the compatibility of the iAge® test with saliva home sample collection kit.
Ambulatory adults, 18 years old and over of diverse ethnicities will be invited to participate in this study from a single site in Marin County. We will choose an equal number of male and female participants by selecting households within a 60 mile radius of the study site.
The study involves fasting blood sample collection to measure and characterize immunomes and inflammatory biomarkers, metabolites, lipid panel, hemoglobin, hemoglobin A1C, and high-sensitivity c-reactive protein (hsCRP). Participants will be asked to provide a blood sample by routine venipuncture at Baseline and approximately 2, 4 and 7 months after the start of the dietary supplement/placebo.
Participants will be given interventions to be taken daily based on their associated immunogroup cluster after each iAge® test is completed. Participants can continue on their current supplements but should not start any new supplements except those given by the study. This study has a different intervention for nine of the ten immunotype clusters. All interventions are i) generally recognized as safe (GRAS) or ii) from compounds at similar concentrations to those found in foods. Participants will be placed in one of ten immunotype clusters after each iAge® test and randomized either to a placebo or the given formulation to be taken once daily (either one, two or three pills depending on the formulation). A participant who changes his/her immunotype cluster after a follow up iAge® test will be given a new dietary intervention (or placebo based on their previous category).
All participants will also be given a Whoop wearable watch to collect information on strain, sleep and heart rate variability. Participants will be asked to complete questionnaires assessing mood, stress level, well-being, cognition, health and lifestyle. We will also obtain the following measurements: (1) Height and weight, (2) blood pressure, (3) waist and hip measurements, (4) pulse wave velocity (PWV) to measure arterial stiffness (5) timed up and go to assess frailty and (6) facial and scalp photos.
A gut microbiome sampling using a third party kit for fecal collection will be obtained at each designated time point from those participants who agree to have fecal sample collection. A subset of participants will have the following procedures done at any time point during the study: (1) saliva collection, (2) heel bone density, (3) audiometry test, (4) home blood sample collection using the Tasso device, ADX100, and ViveBio device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplements | Active Comparator | Dietary supplements are either (1) designated as Generally Recognized As Safe (GRAS) by the Food and Drug Administration or (2) compounds at similar concentrations to those found in foods. |
|
| Placebo | Placebo Comparator | Placebo-matched formulations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement | Dietary Supplement | iron bisglycinate manganese chloride vitamin D2 guar gum indole-3-carbinol L-methionine piceatannol biotin caffeine beta-carotene lutein zinc sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory age (iAge®) scores from Baseline to end of study intervention | Measurement of iAge® scores in all study participants. Peripheral blood samples will be collected, processed and analyzed and iAge is measured using standardized procedures, immune phenotyping and artificial intelligence algorithms. | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in immune protein biomarkers from Baseline to end of study intervention | Blood sample measurements of the levels of the biomarkers Eotaxin-1 (CCL11), Interferon-gamma, Growth Regulated Oncogene-alpha, Monokine Induced by Gamma Interferon (MIG) and TNF-related Apoptosis Inducing Ligand (TRAIL) | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Measure | Description | Time Frame |
|---|---|---|
| Track fitness performance biometrics from Baseline to end of study intervention | Measurement and monitoring of sleep, strain, and heart rate variability using the WHOOP wearable device | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Assessment of skin and scalp health from Baseline to end of study intervention |
Inclusion Criteria:
Exclusion Criteria:
At the time of enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| David Furman, PhD | Chairman of the Scientific Advisory Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Follette Ob-Gyn & Aesthetics | Greenbrae | California | 94904 | United States | ||
| Herman Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31270435 | Background | Veselkov K, Gonzalez G, Aljifri S, Galea D, Mirnezami R, Youssef J, Bronstein M, Laponogov I. HyperFoods: Machine intelligent mapping of cancer-beating molecules in foods. Sci Rep. 2019 Jul 3;9(1):9237. doi: 10.1038/s41598-019-45349-y. | |
| 31504186 | Background | Woo G, Fernandez M, Hsing M, Lack NA, Cavga AD, Cherkasov A. DeepCOP: deep learning-based approach to predict gene regulating effects of small molecules. Bioinformatics. 2020 Feb 1;36(3):813-818. doi: 10.1093/bioinformatics/btz645. |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Participants will receive a formulation of dietary supplements based on the iAge test. Different formulations contain different combinations of dietary supplements.
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| Placebo | Other | Matched Placebo to Intervention |
|
| Change in values for hemoglobin, A1C, high sensitivity C-reactive protein (hs-CRP), and lipid panel from Baseline to end of study intervention | Blood samples measured for hemoglobin, A1C, hs-CRP, and lipid panel | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Anthropometric and metabolic measurements from Baseline to end of study intervention | Measurement of height, weight, body mass index (BMI), waist-to-hip ratio | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Change in cardiovascular health from Baseline to end of study intervention | Measurement of blood pressure, pulse wave velocity using the Whithings Cardio device and heart rate variability with the Whoop wearable | Measured at Baseline, Day 50, Day 120 and Day 210 |
| Correlation of iAge score with ankle bone density score | Measurement of ankle bone density using the GE Achilles Lunar Express ultrasonometer | Measured at a single time point during the duration of the study |
| Correlation of iAge score with hearing test score | Measurement of hearing acuity using the Shoebox Audiometry System | Measured at a single time point during the duration of the study |
| Change in frailty and mobility from Baseline to end of study intervention | Timed Up and Go (TUG) test will be use to measure the length of time in seconds it takes for the participant to stand from a chair, walk 3 meters, turn around and sit back in the chair. TUG is a simple sensitive test to assess mobility, balance, walking ability, and fall risk in older adults. | Measured at Baseline and Day 210 |
Facial and scalp photos will be taken using an iPAD |
| Measured at Baseline, Day 50, Day 120 and Day 210 |
| Saliva sample collection | General and oral health assessment through saliva sample collection in a subset of participants | Measured at Baseline in a subset of participants |
| Changes in the gut microbiome at Baseline to end of study intervention in a subset of participants | Evaluate changes in the gut microbiome using the Thryve Gut Health Test Kit to collect stool samples | Measured at a single time point during the duration of the study in a subset of participants |
| Correlation of standard venipuncture with at-home Tasso, ADX100m and ViveBio collection system in predicting iAge | Capillary blood collection using the at-home Tasso, ADX100 and ViveBio collection system in a subset of study participants | Measured at Baseline in a subset of participants |
| Changes in metabolomic profile | In a subset of participants, metabolite analysis of blood plasma using high-throughput technology | Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants |
| Skin pH | Skin pH probe | Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants |
| Suwanee |
| Georgia |
| 30024 |
| United States |
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