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

NCT06630637 | Completed

• 1 other identifier: HO_prospective
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Healthy; Digital Health

Keywords

Continuous Glucose Monitoring (CGM); Intermittent Fasting (IF); Ketone Measurement; Wearable Technology; Exercise Routines; Heat/Cold Interventions; Diet and Supplements; Human Optimization; N-of-1; Single Participant; Personalized Health; Digital Health; Sensors

Outcome Measures

Primary Outcomes (39)

• Metabolic biomarker analysis: total cholesterol levels

  Blood testing of total cholesterol: milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: low density lipoprotein (LDL) cholesterol levels

  Blood testing of LDL cholesterol: milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: high density lipoprotein (HDL) cholesterol levels

  Blood testing of HDL cholesterol: milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: triglycerides levels

  Blood testing of triglycerides: milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: apolipoprotein B (ApoB) levels

  Blood testing of apolipoprotein B (ApoB): milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: apolipoprotein A1 (ApoA1) levels

  Blood testing of apolipoprotein A1 (ApoA1): milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: C reactive protein (CRP) levels

  Blood testing of C reactive protein (CRP): milligrams per liter (mg/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 1β (IL- 1β) levels

  Blood testing of IL- 1β: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 6 (IL- 6) levels

  Blood testing of IL-6: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 8 (IL- 8) levels

  Blood testing of IL-8: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 10 (IL- 10) levels

  Blood testing of IL-10: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 12 (IL- 12) levels

  Blood testing of IL-12: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: interleukin 17 (IL- 17) levels

  Blood testing of IL-17: picograms per milliliter (pg/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: omega 3:6 ratio

  Blood testing of omega 3:6 ratio (no specific units)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Microtubule-associated protein 1A/1B-light chain 3 (LC3) levels

  Blood testing of autophagy biomarker LC3: Nanograms per milliliter (ng/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Sequestosome 1 (p62/SQSTM1) levels

  Blood testing of autophagy biomarker p62/SQSTM1: Nanograms per milliliter (ng/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Beclin-1 levels

  Blood testing of autophagy biomarker Beclin-1: Nanograms per milliliter (ng/mL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Red Blood Cells (RBCs)

  Red Blood Cells (RBCs): Million cells per microliter (million/µL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: White Blood Cells (WBCs)

  White Blood Cells (WBCs): Thousand cells per microliter (thousand/µL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Hemoglobin (Hb)

  Hemoglobin (Hb): Grams per deciliter (g/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Hematocrit (Hct)

  Hematocrit (Hct): Percentage (%)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Platelets (PLT)

  Platelets (PLT): Thousand cells per microliter (thousand/µL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Blood Urea Nitrogen (BUN)

  Blood Urea Nitrogen (BUN): Milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Creatinine

  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)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Estimated Glomerular Filtration Rate (eGFR)

  Estimated Glomerular Filtration Rate (eGFR): Milliliters per minute per 1.73 square meters (mL/min/1.73m²)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Sodium

  Sodium: Milliequivalents per liter (mEq/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Potassium

  Potassium: Milliequivalents per liter (mEq/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Chloride

  Chloride: Milliequivalents per liter (mEq/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Alanine Aminotransferase (ALT)

  Alanine Aminotransferase (ALT): Units per liter (U/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Aspartate Aminotransferase (AST)

  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)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Alkaline Phosphatase (ALP)

  Alkaline Phosphatase (ALP): Units per liter (U/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Total Bilirubin

  Total Bilirubin: Milligrams per deciliter (mg/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Metabolic biomarker analysis: Albumin

  Albumin: Grams per deciliter (g/dL)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Microbial diversity

  Stool/saliva analysis of microbial diversity: Shannon diversity index (no specific units)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Taxonomic abundance

  Stool/saliva analysis of taxonomic abundance: reads per million (RPM)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Concentrations of metabolites

  Stool/saliva analysis of concentrations of metabolites: Micromoles per liter (µmol/L)

  Pre and post 48 hour fasts (2 fasts per month for 12 months)

• Glycemic and ketone monitoring for adherence assessment

  Glucose-Ketone Index (GKI): A calculated value derived from dividing the blood glucose level (in mmol/L) by the ketone level (in mmol/L).

  10 times per day for up to 12 months

• Wearable health metrics analysis for physiological monitoring

  Apple Watch 9 and Whoop data \[heart rate variability (HRV), resting heart rate, cardio recovery, sleep duration, composition (stages of sleep) and analogous scores, potential maximum rate of oxygen consumption attainable during physical exertion (VO2 max), basal metabolic rate and potential respiratory rate\].

  Daily for up to 12 months

• Artificial intelligence (AI)-enhanced visual data representation for activity monitoring

  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.

  Once a month for up to 12 months

Other Outcomes (1)

• Qualitative assessment of participant experience

  Day one, day 8, at study completion (12 months)

Study Arms (1)

Personalized Health Intervention Arm

EXPERIMENTAL

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.

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

Interventions

Glucose-Ketone Index (GKI) monitoring BEHAVIORAL

Ketone and blood glucose monitoring with Abbott Optium Neo up to 10 times per day to observe GKI dynamics for gamification of adherence.

Personalized Health Intervention Arm

Continuous Glucose Monitoring (CGM) BEHAVIORAL

Monitoring with an Abbott Freestyle Libre to observe glucose dynamics for gamification of adherence.

Personalized Health Intervention Arm

Digital dynamometer OTHER

Grip strength measurements, right and left hand, up to 20 readings per day per hand.

Personalized Health Intervention Arm

Wearables DEVICE

All Apple Watch 9 and Whoop data daily \[heart rate variability (HRV), resting heart rate, cardio recovery, sleep duration, composition (stages of sleep) and analogous scores, potential maximum rate of oxygen consumption attainable during physical exertion (VO2 max), basal metabolic rate and potential respiratory rate\].

Personalized Health Intervention Arm

Blood tests DIAGNOSTIC_TEST

Pre- and Post-fast (48h) testing of lipid panel, ApoB, ApoA1, CRP, interleukin panel, omega 3:6 ratio, and autophagy analysis. Potential CBC, renal and liver panels to be taken where appropriate.

Personalized Health Intervention Arm

Stool tests DIAGNOSTIC_TEST

15 g of stool will be collected from the subject pre- and post-fast for microbiome assessment and pre- and post- the first week (the "three meal phase"). After the first week, the maximum number of tests is four per month (maximum of two fasts, with a pre- and post-fast test for each fast).

Personalized Health Intervention Arm

Saliva tests DIAGNOSTIC_TEST

Saliva samples will be collected from the subject pre- and post-fast for microbiome assessment. Maximum number of tests is four per month (maximum of two fasts, with a pre- and post-fast test for each fast).

Personalized Health Intervention Arm

Fitness intervention BEHAVIORAL

90 minutes of strength and/or cardiovascular training for a minimum of 5 days per week.

Personalized Health Intervention Arm

Cold & heat intervention BEHAVIORAL

Cold plunge: at least 3 days per week, 2 sessions of maximum 5 minutes each (minimum 2 minutes between sessions) at a minimum of 6 degrees Celsius. Potential inclusion of GKI measurements before and after plunge. Heat Therapy: maximum of 2 sessions of 20 minutes each of dry sauna blanket (minimum 5 minutes break between sessions) following the cold plunge intervention.

Personalized Health Intervention Arm

Airofit DEVICE

Airofit is a smart breathing training device designed to improve respiratory strength and efficiency. It is used for enhancing sport performance, well-being, and overall health. The device works by providing adjustable resistance to breathing muscles. 5-10 minutes of daily use.

Personalized Health Intervention Arm

18h fasting BEHAVIORAL

Minimum of 18 hours fasting per day, with feeding window to occur between 5pm-8pm or 12pm-3pm. The fasting procedures will occur only after the Three Meal Phase.

Personalized Health Intervention Arm

48h fasting BEHAVIORAL

48h fasting maximum twice monthly, at least one week apart. Multivitamin and electrolytes with water, and black coffee or tea (0-calorie drinks) will be consumed.The fasting procedures will occur the Three Meal Phase.

Personalized Health Intervention Arm

Three meal phase BEHAVIORAL

During the first week of the study, the participant will follow a regime of three meals per day.

Personalized Health Intervention Arm

Mediterranean-inspired diet BEHAVIORAL

Regimen of Mediterranean-inspired nutrition comprised of Olive Oil, Olives, Leafy Green Vegetables, Lean Protein (Beef, Chicken, Lamb, Pork, Duck, Salmon, Tuna), Chia Seeds, Pecans, Macadamia, Pumpkin Seeds, Walnuts, Greek Yogurt, Salt, Pepper, Paprika, Cumin, Garlic powder, onion powder; Fruit: Blueberry, Grapefruit; Carbohydrates: Rolled Oats; Hydration: Water, Black Coffee, Black Tea, Coke Zero and 100 Zero sparingly, Ultima electrolytes. Photographs of meals will be taken to create a visual record of the diet followed. Photographs of the devices will be taken to create a visual record of the blood glucose and ketone concentration results.

Personalized Health Intervention Arm

Supplements DIETARY_SUPPLEMENT

Multivitamin (Centrum), Vitamin D (Up to 2000 IU per day), Creatine (Up to 2000mg), Fisetin (1 pill), Omega-3 (1 tablet), Turmeric, Pre-Probiotic, Blueberry Extract, Holy Basil Extract.

Personalized Health Intervention Arm

Generative AI BEHAVIORAL

Feeding ketone data, glucose data (from finger prick and/or CGM), any/all Apple Watch 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.

Personalized Health Intervention Arm

Interviews OTHER

Three interviews, of 30-60 minutes each one, at baseline, end of three meal phase and end of study, to gain insights into the participant's experience. Exploration of daily routines including diet, exercise and the use of technology and aspects of a healthy lifestyle.

Personalized Health Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Digital Medicine (WisDM): lead

Study Sites (1)

The Institute for Digital Medicine (WisDM)

Singapore, Singapore, 117456, Singapore

Location

Related Publications (5)

• Mandal S, Simmons N, Awan S, Chamari K, Ahmed I. Intermittent fasting: eating by the clock for health and exercise performance. BMJ Open Sport Exerc Med. 2022 Jan 7;8(1):e001206. doi: 10.1136/bmjsem-2021-001206. eCollection 2022.

  PMID: 35070352 BACKGROUND

• Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.

  PMID: 28715993 BACKGROUND

• Levy E, Chu T. Intermittent Fasting and Its Effects on Athletic Performance: A Review. Curr Sports Med Rep. 2019 Jul;18(7):266-269. doi: 10.1249/JSR.0000000000000614.

  PMID: 31283627 BACKGROUND

• Tinsley GM, La Bounty PM. Effects of intermittent fasting on body composition and clinical health markers in humans. Nutr Rev. 2015 Oct;73(10):661-74. doi: 10.1093/nutrit/nuv041. Epub 2015 Sep 15.

  PMID: 26374764 BACKGROUND

• Wang P, Tadeo X, Chew HSJ, Sapanel Y, Ong YH, Leung NYT, Chow EK, Ho D. N-of-1 health optimization: Digital monitoring of biomarker dynamics to gamify adherence to metabolic switching. PNAS Nexus. 2024 May 30;3(6):pgae214. doi: 10.1093/pnasnexus/pgae214. eCollection 2024 Jun.

  PMID: 38881838 BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting; Ketosis

Interventions

Continuous Glucose Monitoring; Hematologic Tests; Occult Blood; Cold Temperature; Interviews as Topic

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health

Study Officials

• Dean Ho, PhD

  The Institute for Digital Medicine (WisDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the N.1 Institute for Health

Model Details: This is an N-of-1 trial involving a single participant.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: October 7, 2024
• Primary Completion: June 7, 2025
• Study Completion: July 2, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)