Monitoring Intermittent Fasting for Human Optimization Using Wearable Technology: An N-of-1 Study

Not Applicable

Not yet recruiting

• Conditions: Intermittent Fasting; Healthy; Digital Health
• Interventions: Behavioral: Glucose-Ketone Index (GKI) monitoring; Behavioral: Continuous Glucose Monitoring (CGM); Other: Digital dynamometer; Device: Wearables; Diagnostic Test: Blood tests; Diagnostic Test: Stool tests; Diagnostic Test: Saliva tests; Behavioral: Fitness intervention; Behavioral: Cold & heat intervention; Device: Airofit; Behavioral: 18h fasting; Behavioral: 48h fasting; Behavioral: Three meal phase; Behavioral: Mediterranean-inspired diet; Dietary Supplement: Supplements; Behavioral: Generative AI; Other: Interviews

• Registration Number: NCT06630637
• Lead Sponsor: Institute for Digital Medicine (WisDM)

Brief Summary

There is a growing interest in personalized health strategies, including diet, exercise, and fasting regimens, to enhance metabolic fitness. Recent research indicates that intermittent fasting (IF) is useful not only for weight management, but also for energy production and improvement of metabolic well-being.

IF can potentially reduce systemic inflammation and help to prevent chronic diseases. IF research can also help athletes sustain performance during fasting periods. This prospective study aims to investigate the effects of a human optimization program on an individual\'s metabolic health and overall well-being.

This research examines the correlations between continuous glucose monitoring, ketone measurement, exercise routines, heat/cold interventions, diet, supplements and intermittent fasting patterns. The study involves a single participant -the principal investigator- who will adhere to a personalized regimen involving wearable monitoring of metabolic changes, training and intermittent fasting. This research seeks to understand the potential relationships between these factors, contributing to the emerging knowledge on individualized health optimization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study Start: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-10-07
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• The principal investigator is the sole participant in this N-of-1 trial: a healthy individual with no chronic diseases or conditions affecting metabolic health.

Exclusion Criteria

• The principal investigator is the sole participant in this N-of-1 trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized Health Intervention Arm	Digital dynamometer	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Glucose-Ketone Index (GKI) monitoring	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Continuous Glucose Monitoring (CGM)	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Wearables	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Blood tests	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Stool tests	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Saliva tests	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Fitness intervention	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Cold & heat intervention	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Airofit	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	18h fasting	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	48h fasting	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Three meal phase	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Mediterranean-inspired diet	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Supplements	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Generative AI	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.
Personalized Health Intervention Arm	Interviews	This arm involves the the single participant following a personalized regimen that includes intermittent fasting, exercise routines, heat/cold interventions, diet modifications, and supplementation. The participant will engage in continuous monitoring of metabolic changes using wearable technology, continuous glucose monitoring, and ketone measurements, along with blood, saliva, and stool lab tests. The goal is to assess the effects of these interventions on metabolic health and overall well-being, identifying potential trends and correlations throughout the study period.

Primary Outcome Measures

Name	Time	Method
Metabolic biomarker analysis: total cholesterol levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of total cholesterol: milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: low density lipoprotein (LDL) cholesterol levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of LDL cholesterol: milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: high density lipoprotein (HDL) cholesterol levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of HDL cholesterol: milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: triglycerides levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of triglycerides: milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: apolipoprotein B (ApoB) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of apolipoprotein B (ApoB): milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: apolipoprotein A1 (ApoA1) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of apolipoprotein A1 (ApoA1): milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: C reactive protein (CRP) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of C reactive protein (CRP): milligrams per liter (mg/L)
Metabolic biomarker analysis: interleukin 1β (IL- 1β) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL- 1β: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: interleukin 6 (IL- 6) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL-6: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: interleukin 8 (IL- 8) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL-8: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: interleukin 10 (IL- 10) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL-10: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: interleukin 12 (IL- 12) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL-12: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: interleukin 17 (IL- 17) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of IL-17: picograms per milliliter (pg/mL)
Metabolic biomarker analysis: omega 3:6 ratio	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of omega 3:6 ratio (no specific units)
Metabolic biomarker analysis: Microtubule-associated protein 1A/1B-light chain 3 (LC3) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of autophagy biomarker LC3: Nanograms per milliliter (ng/mL)
Metabolic biomarker analysis: Sequestosome 1 (p62/SQSTM1) levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of autophagy biomarker p62/SQSTM1: Nanograms per milliliter (ng/mL)
Metabolic biomarker analysis: Beclin-1 levels	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood testing of autophagy biomarker Beclin-1: Nanograms per milliliter (ng/mL)
Metabolic biomarker analysis: Red Blood Cells (RBCs)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Red Blood Cells (RBCs): Million cells per microliter (million/µL)
Metabolic biomarker analysis: White Blood Cells (WBCs)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	White Blood Cells (WBCs): Thousand cells per microliter (thousand/µL)
Metabolic biomarker analysis: Hemoglobin (Hb)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Hemoglobin (Hb): Grams per deciliter (g/dL)
Metabolic biomarker analysis: Hematocrit (Hct)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Hematocrit (Hct): Percentage (%)
Metabolic biomarker analysis: Platelets (PLT)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Platelets (PLT): Thousand cells per microliter (thousand/µL)
Metabolic biomarker analysis: Blood Urea Nitrogen (BUN)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Blood Urea Nitrogen (BUN): Milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: Creatinine	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Creatinine: Milligrams per deciliter (mg/dL) Estimated Glomerular Filtration Rate (eGFR): Milliliters per minute per 1.73 square meters (mL/min/1.73m²) Sodium: Milliequivalents per liter (mEq/L) Potassium: Milliequivalents per liter (mEq/L) Chloride: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Estimated Glomerular Filtration Rate (eGFR)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Estimated Glomerular Filtration Rate (eGFR): Milliliters per minute per 1.73 square meters (mL/min/1.73m²)
Metabolic biomarker analysis: Sodium	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Sodium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Potassium	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Potassium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Chloride	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Chloride: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Alanine Aminotransferase (ALT)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Alanine Aminotransferase (ALT): Units per liter (U/L)
Metabolic biomarker analysis: Aspartate Aminotransferase (AST)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Aspartate Aminotransferase (AST): Units per liter (U/L) Alkaline Phosphatase (ALP): Units per liter (U/L) Total Bilirubin: Milligrams per deciliter (mg/dL) Albumin: Grams per deciliter (g/dL)
Metabolic biomarker analysis: Alkaline Phosphatase (ALP)	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Alkaline Phosphatase (ALP): Units per liter (U/L)
Metabolic biomarker analysis: Total Bilirubin	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Total Bilirubin: Milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: Albumin	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Albumin: Grams per deciliter (g/dL)
Microbial diversity	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Stool/saliva analysis of microbial diversity: Shannon diversity index (no specific units)
Taxonomic abundance	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Stool/saliva analysis of taxonomic abundance: reads per million (RPM)
Concentrations of metabolites	Pre and post 48 hour fasts (2 fasts per month for 12 months)	Stool/saliva analysis of concentrations of metabolites: Micromoles per liter (µmol/L)
Glycemic and ketone monitoring for adherence assessment	10 times per day for up to 12 months	Glucose-Ketone Index (GKI): A calculated value derived from dividing the blood glucose level (in mmol/L) by the ketone level (in mmol/L).
Wearable health metrics analysis for physiological monitoring	Daily for up to 12 months	Apple Watch 9 and Whoop data \[heart rate variability (HRV), resting heart rate, cardio recovery, sleep duration, composition (stages of sleep) and analogous scores, potential maximum rate of oxygen consumption attainable during physical exertion (VO2 max), basal metabolic rate and potential respiratory rate\].
Artificial intelligence (AI)-enhanced visual data representation for activity monitoring	Once a month for up to 12 months	Feeding ketone data, glucose data, any/all wearable data, and dietary images into a generative AI platform to convert data into images using any selected prompts, with the intent of the images serving as immediate, visual readouts as a function of activity and/or inactivity.