The January Application NUtritional Study (JANUS)

NCT03604250 | Suspended

• 1 other identifier: 2018-44
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 will help people optimize their health through lifestyle interventions and supplementation with prebiotics.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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+)

  11 weeks

Study Arms (1)

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.

Dietary Supplement: Lifestyle plus prebiotic supplement

Interventions

Lifestyle plus prebiotic supplement DIETARY_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.

Lifestyle plus prebiotics

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• January, Inc.: lead

Study Sites (1)

January, Inc.

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dalia Perelman, MS, RD, CDE

  January, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: May 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)