The January Application NUtritional Study (JANUS) (JANUS)

June 4, 2020 updated by: January, Inc.

The January Application NUtritional Study: Health Optimization by Wearable Devices - a Pilot Trial

Human beings react differently to changes in diet, exercise, and sleep patterns. The goal of this study is to (1) learn how individuals react to lifestyle choices and suggestions by examining a small group of people with similar health and lifestyle profiles; and (2) to develop algorithmic policies (male/female) that will help people optimize their health through lifestyle interventions and supplementation with prebiotics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Human beings react differently to changes in diet, exercise, and sleep patterns. The goal of this study is two-fold and consists of two phases involving the same subjects. In the first phase, the study aims to learn how individuals react to lifestyle choices and suggestions by examining a small group of people with similar health and lifestyle profiles. Specifically, how their food choices, physical activity pattern, sleep pattern, and stress levels affect glucose metabolism, stress response, inflammation, and microbiome composition.

In the second phase of the study, the investigator's goal is to use the data collected to develop algorithmic policies that will help people optimize their health through lifestyle interventions and supplementation with prebiotics. The ultimate goal is to achieve optimization of glucose and stress regulation, inflammation state, and microbiome composition by observing real-time variations of these regulatory systems through the use of wearable health-monitoring devices and providing lifestyle suggestions via a mobile application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Menlo Park, California, United States, 94025
        • January, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gender: Both women and men
  • Age: between 30 and 60 years
  • Ethnicity and race: All
  • Are prediabetic (HbA1c </= 6.4 in the past 3 months), or have a fasting plasma glucose > 110 mg/dL, or have 2 of the metabolic syndrome criteria as defined by the International Diabetes Federation (IDF):

Central obesity, defined as waist circumference >/ = 94 cm for men and >/= 80 cm for women, or a BMI > 30 kg/m2 plus any two of the following four factors:

  • Raised triglycerides: >/= 150 mg/dL or specific treatment for this lipid abnormality
  • Reduced HDL cholesterol:
  • Men: < 40 mg/dL
  • Women: < 50 mg/dL
  • Raised blood pressure (BP): systolic BP >/= 130 mmHg or diastolic BP >/= 85 mmHg, or treatment of previously diagnosed hypertension

  • Raised fasting plasma glucose (FPG): FPG >/= 100 mg/dL

    • Have elevated levels of at least one of the following inflammatory markers: C-Reactive Protein (CRP), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon gamma (IFN-G), Interleukins (IL-1b, IL-2, IL-6, IL-8, IL-10, IL-12p70), and Tumor necrosis factor alpha (TNF-a).
    • Are able to utilize a smart-phone and own an Android (v18+) or Apple phone (i0S9+)
    • Are willing to being tracked, provide multiple samples and wear a glucose monitor and a smartwatch 24 hours/day for 77 days
    • Are willing to perform finger-stick blood draws
    • Are willing to limit swimming to a maximum of 30 minutes per session during the trial
    • Are willing to limit traveling to the weekend days
    • Live in the vicinity of January Inc office and/or MBC Biolabs (Approximately 25 mile radius)
    • Are available for two, 2-4-hour meetings (study orientation and study close-out)
    • Eat a steady, consistent diet on a daily basis (see dietary exclusions below)
    • Are able to run for the time required to establish VO2 max (3-20 minutes).
    • Have the ability and willingness to give written informed consent

Exclusion Criteria:

  • Smokers
  • BMI =/> 40
  • Actively losing weight
  • Unstable diet (defined as having made any major changes to usual diet such as eliminating or significantly increasing a major food group)

  • Use of the following medications:

    • Blood thinners (i.e. warfarin/Coumadin, clopidogrel/Plavix)
    • Daily oral corticosteroids
    • Hypoglycemic medication (i.e. Precose, Metformin, Avandia, Victoza)
    • Weight loss medication
    • Digoxin/Lanoxin
    • Lithium/Lithobid
    • Theophylline/Theo 24
  • Use of the following supplements, unless they agree to discontinue starting 30 days prior to the trial: any nutritional supplements containing antioxidants (examples: multi-vitamins, antioxidant combinations, or any supplement containing vitamin C, vitamin E, beta-carotene or other carotenoids, or selenium), and fish oil/cod liver oil, flaxseed oil, and supplements containing Conjugated linoleic acid (CLA)/Gamma-linolenic acid (GLA) or turmeric.
  • Use of antibiotics, antifungals/antiparasitics in the last 30 days
  • Use of probiotic or prebiotic supplements in the last 30 days
  • People allergic to: adhesives and/or prebiotics used in the trial
  • Pregnant, lactating, have given birth in the past 6 months, or are planning to get pregnant in the next 4 months

  • Self-reported health conditions:

    • Diabetes (T1D or T2D)
    • Inflammatory Bowel Disease (Crohn's, Ulcerative Colitis)
    • Gastroenteritis, colitis or gastritis
    • Active, uncontrolled Clostridium difficile infection or H. pylori (untreated)
    • Recent heart attack (past 6 months), history of arrhythmias or cerebrovascular disease
    • Undergoing treatment for, or underwent treatment for cancer in the past 6 months
    • Esophageal, stomach colon or pancreatic cancer
    • Liver disease, other than fatty liver disease
    • Immunosuppression or immunodeficiency
    • Positive test for HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
    • Musculoskeletal disorder that would preclude you from performing moderate physical activity
    • LDL cholesterol =/> 190 mg/dL
    • Triglycerides (TG) =/> 450 mg/dL
    • Adrenalectomy
    • Pituitary tumor
    • Hypothalamic disease
    • Stage 3 kidney disease or worse
    • Celiac disease confirmed by blood test or biopsy
    • Insulinoma
    • Cushing's disease
    • Hyperthyroidism
    • Acromegaly
    • Pheochromocytoma
    • Addison's disease
    • Galactosemia
    • Glycogen storage disease
    • Hereditary fructose intolerance
    • Psychotic disorders or bipolar disorders
    • Current eating disorder
  • History of bariatric surgery, gallbladder removal, small bowel resection, or extensive bowel resection
  • Hospitalization for depression in past 6 months
  • Self-reported alcohol or substance abuse within the past 12 months
  • Current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems
  • Self-reported inability to walk two blocks
  • Restrictive diets (i.e. vegetarians, vegans, or very restrictive diets, i.e. Paleo, Atkins, Ornish or ketogenic diets)
  • Planned travel (outside of weekends) over the course of the study (77 days) (weekend travel is ok)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lifestyle plus prebiotics
Research participants will be asked to wear health monitoring devices, including a continuous glucose monitoring device and an Apple watch. They may be prompted to perform lifestyle modifications aimed at better understanding their health parameters, based on the results obtained from the wearable devices and other tests. During the last 3 weeks of the study, research participants may be asked to take a personalized prebiotic supplement, up to once/day.
Dietary supplement: Lifestyle plus prebiotic supplement
Research participants will be asked to wear health monitoring devices, including a continuous glucose and heart-rate monitors. They may be prompted to perform lifestyle modifications aimed at better understanding their health parameters, based on the results obtained from the wearable devices and other tests. During the last 3 weeks of the study, research participants may be asked to take a personalized prebiotic supplement, up to once/day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Health Score (THS)
Time Frame: 11 weeks

The primary outcome of the study is the calculation of a Total Health Score (THS) which will include scores of body composition, glucose and stress regulation, inflammation state, and microbiome composition, based on the following data:

  • Anthropometrics
  • Blood pressure
  • Heart Rate
  • Glucose
  • Hemoglobin A1c
  • Metabolic panel
  • Complete Blood Count
  • Glomerular Filtration Rate
  • Inflammatory markers
  • Serum lipids
  • Thyroid-stimulating hormone
  • Blood ketones
  • Cortisol
  • C-peptides
  • Metagenomics
  • Metabolomics
  • 16S rRNA sequencing
  • Human genome assays (SNP, Exome+)
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
January, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dalia Perelman, MS, RD, CDE, January, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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