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Completed

NCT Number: NCT06630637

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

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Institute for Digital Medicine (WisDM)

Singapore, 117456

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Continuous Glucose Monitoring (CGM)

Behavioral

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

Digital dynamometer

Other

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

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].

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.

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).

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).

Fitness intervention

Behavioral

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

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.

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.

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.

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.

Three meal phase

Behavioral

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

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.

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.

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.

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. Metabolic biomarker analysis: Hematocrit (Hct)

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

    Hematocrit (Hct): Percentage (%)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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).

  38. 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].

  39. 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.

Other outcomes

  1. Qualitative assessment of participant experience

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

    This outcome involves conducting interviews with the participant to gather qualitative data on the experiences, challenges, and adherence related to the dietary and exercise interventions throughout the study. The interviews aim to provide insights into the participant's perceptions of the interventions, their effects on metabolic health and overall well-being, and any adjustments needed for optimal adherence and outcomes.

Sponsors and collaborators

Lead sponsor

Institute for Digital Medicine (WisDM)

Other

Registry information

Official study title

Intermittent Fasting Monitoring for Human Optimization Utilizing Wearable Technology: an N-of-1 Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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