Intermittent FastingNCT06630637
Monitoring Intermittent Fasting for Human Optimization Using Wearable Technology: An N-of-1 Study
A study testing Glucose-Ketone Index (GKI) monitoring, Continuous Glucose Monitoring (CGM) and Digital dynamometer in people with Intermittent Fasting and Healthy, run by Institute for Digital Medicine (WisDM) at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Healthy, Digital Health
- What is being tested?
- Glucose-Ketone Index (GKI) monitoring, Continuous Glucose Monitoring (CGM) and Digital dynamometer
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Oct 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The principal investigator is the sole participant in this N-of-1 trial.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
The Institute for Digital Medicine (WisDM)
Singapore, Singapore, 117456
About this study
Official title: Intermittent Fasting Monitoring for Human Optimization Utilizing Wearable Technology: an N-of-1 Prospective Study
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
- Being tested
- Glucose-Ketone Index (GKI) monitoring, Continuous Glucose Monitoring (CGM), Digital dynamometer, Wearables, Blood tests
- 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
- Medical subject headings
- Intermittent Fasting, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-Ketone Index (GKI) monitoringBehavioural
Ketone and blood glucose monitoring with Abbott Optium Neo up to 10 times per day to observe GKI dynamics for gamification of adherence.
Continuous Glucose Monitoring (CGM)Behavioural
Monitoring with an Abbott Freestyle Libre to observe glucose dynamics for gamification of adherence.
Digital dynamometerOther
Grip strength measurements, right and left hand, up to 20 readings per day per hand.
WearablesDevice
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].
Blood testsDiagnostic 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.
Stool testsDiagnostic 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).
Saliva testsDiagnostic 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).
Fitness interventionBehavioural
90 minutes of strength and/or cardiovascular training for a minimum of 5 days per week.
Cold & heat interventionBehavioural
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.
AirofitDevice
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.
18h fastingBehavioural
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.
48h fastingBehavioural
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.
Three meal phaseBehavioural
During the first week of the study, the participant will follow a regime of three meals per day.
Mediterranean-inspired dietBehavioural
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.
SupplementsDietary 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.
Generative AIBehavioural
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.
InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic biomarker analysis: total cholesterol levels
Blood testing of total cholesterol: milligrams per deciliter (mg/dL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Metabolic biomarker analysis: Hematocrit (Hct)
Hematocrit (Hct): Percentage (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Metabolic biomarker analysis: Sodium
Sodium: Milliequivalents per liter (mEq/L)
Measured: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Metabolic biomarker analysis: Potassium
Potassium: Milliequivalents per liter (mEq/L)
Measured: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Metabolic biomarker analysis: Chloride
Chloride: Milliequivalents per liter (mEq/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Metabolic biomarker analysis: Albumin
Albumin: Grams per deciliter (g/dL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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].
Measured: 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.
Measured: Once a month for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start7 Oct 2024
- Primary completion7 Jun 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an N-of-1 trial involving a single participant.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Digital Medicine (WisDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dean Ho, The N.1 Institute for Health (N.1)
- Investigators
- Dean Ho, PhD, Principal investigator, The Institute for Digital Medicine (WisDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630637
- Sponsor's protocol ID
- HO_prospective
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35070352Patterson 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.
PubMed 28715993Levy 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.
PubMed 31283627Tinsley 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.
PubMed 26374764Wang 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.
PubMed 38881838
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting Monitoring for Human Optimization Utilizing Wearable Technology: an N-of-1 Prospective Study
- ClinicalTrials.gov ID
- NCT06630637
- Acronym / sponsor ID
- HO_prospective
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institute for Digital Medicine (WisDM)University, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an N-of-1 trial involving a single participant.
| Arm | Type | Receives |
|---|---|---|
| Personalized Health Intervention Arm | Experimental | 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: InterviewsThis 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The principal investigator is the sole participant in this N-of-1 trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose-Ketone Index (GKI) monitoringKetone and blood glucose monitoring with Abbott Optium Neo up to 10 times per day to observe GKI dynamics for gamification of adherence. | Behavioural | Personalized Health Intervention Arm |
| Continuous Glucose Monitoring (CGM)Monitoring with an Abbott Freestyle Libre to observe glucose dynamics for gamification of adherence. | Behavioural | Personalized Health Intervention Arm |
| Digital dynamometerGrip strength measurements, right and left hand, up to 20 readings per day per hand. | Other | Personalized Health Intervention Arm |
| WearablesAll 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]. | Device | Personalized Health Intervention Arm |
| Blood testsPre- 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. | Diagnostic test | Personalized Health Intervention Arm |
| Stool tests15 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). | Diagnostic test | Personalized Health Intervention Arm |
| Saliva testsSaliva 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). | Diagnostic test | Personalized Health Intervention Arm |
| Fitness intervention90 minutes of strength and/or cardiovascular training for a minimum of 5 days per week. | Behavioural | Personalized Health Intervention Arm |
| Cold & heat interventionCold 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. | Behavioural | Personalized Health Intervention Arm |
| AirofitAirofit 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. | Device | Personalized Health Intervention Arm |
| 18h fastingMinimum 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. | Behavioural | Personalized Health Intervention Arm |
| 48h fasting48h 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. | Behavioural | Personalized Health Intervention Arm |
| Three meal phaseDuring the first week of the study, the participant will follow a regime of three meals per day. | Behavioural | Personalized Health Intervention Arm |
| Mediterranean-inspired dietRegimen 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. | Behavioural | Personalized Health Intervention Arm |
| SupplementsMultivitamin (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. | Dietary supplement | Personalized Health Intervention Arm |
| Generative AIFeeding 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. | Behavioural | Personalized Health Intervention Arm |
| InterviewsThree 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. | Other | Personalized Health Intervention Arm |
Primary outcome
Metabolic biomarker analysis: total cholesterol levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Hematocrit (Hct): Percentage (%)
Metabolic biomarker analysis: Platelets (PLT)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Sodium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Potassium
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Potassium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Chloride
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Total Bilirubin: Milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: Albumin
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Albumin: Grams per deciliter (g/dL)
Microbial diversity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 35070352Mandal 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.
- Background: PubMed 28715993Patterson 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.
- Background: PubMed 31283627Levy 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.
- Background: PubMed 26374764Tinsley 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.
- Background: PubMed 38881838Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Ho, PhD principal investigator
The Institute for Digital Medicine (WisDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose-Ketone Index (GKI) monitoring, Continuous Glucose Monitoring (CGM) and Digital dynamometer in people with Intermittent Fasting and Healthy, run by Institute for Digital Medicine (WisDM) at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic biomarker analysis: total cholesterol levels (time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06630637, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.