Metabolic SyndromeJANUSNCT03604250
The January Application NUtritional Study (JANUS)
A study testing Lifestyle plus prebiotic supplement in people with Metabolic Syndrome, run by January, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Lifestyle plus prebiotic supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Lifestyle plus prebiotic supplement
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle plus prebiotic supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle plus prebiotics | Experimental | 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. Receives: Dietary Supplement: Lifestyle plus prebiotic supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Health Score (THS)
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+)
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 May 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Why it stopped: Study protocol under revision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot trial with a single group of 14 participants: 10 with prediabetes or at least 2 of the metabolic syndrome criteria (half males, half females) 4 healthy people (do not have prediabetes nor any of the metabolic syndrome criteria) of 11 weeks (77 days) duration.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- January, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalia Perelman, MS, RD, CDE, Principal investigator, January, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604250
- Sponsor's protocol ID
- 2018-44
- Acronym
- JANUS
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The January Application NUtritional Study: Health Optimization by Wearable Devices - a Pilot Trial
- ClinicalTrials.gov ID
- NCT03604250
- Acronym / sponsor ID
- JANUS / 2018-44
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study protocol under revision.
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- January, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot trial with a single group of 14 participants: 10 with prediabetes or at least 2 of the metabolic syndrome criteria (half males, half females) 4 healthy people (do not have prediabetes nor any of the metabolic syndrome criteria) of 11 weeks (77 days) duration.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle plus prebiotics | Experimental | Dietary Supplement: Lifestyle plus prebiotic supplementResearch 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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:
Key exclusion criteria (54 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle plus prebiotic supplementResearch 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. | Dietary supplement | Lifestyle plus prebiotics |
Primary outcome
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+)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Perelman, MS, RD, CDE principal investigator
January, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle plus prebiotic supplement in people with Metabolic Syndrome, run by January, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Health Score (THS) (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.