The January Application NUtritional Study: Health Optimization by Wearable Devices - a Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- January, Inc.
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Total Health Score (THS)
- Status
- Suspended
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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+)