The January Application NUtritional Study (JANUS)

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Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT03604250

Run by

January, Inc.

People needed

14

Starts

2021-05-01

Expected to finish

2021-10-01

Last updated by the study team

2020-06-09

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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
• 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

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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