The Institute for Digital Medicine (WisDM)
Singapore, 117456
NCT Number: NCT06630637
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.
Looking for future studies?
Notify Me21 year and older
Male
Interventional
Not applicable
Singapore, 117456
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ketone and blood glucose monitoring with Abbott Optium Neo up to 10 times per day to observe GKI dynamics for gamification of adherence.
Monitoring with an Abbott Freestyle Libre to observe glucose dynamics for gamification of adherence.
Grip strength measurements, right and left hand, up to 20 readings per day per hand.
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].
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.
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 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).
90 minutes of strength and/or cardiovascular training for a minimum of 5 days per week.
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 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.
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 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.
During the first week of the study, the participant will follow a regime of three meals per day.
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.
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.
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.
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.
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)
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)
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)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Blood testing of triglycerides: milligrams per deciliter (mg/dL)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Hemoglobin (Hb): Grams per deciliter (g/dL)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Hematocrit (Hct): Percentage (%)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Platelets (PLT): Thousand cells per microliter (thousand/µL)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Blood Urea Nitrogen (BUN): Milligrams per deciliter (mg/dL)
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)
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)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Sodium: Milliequivalents per liter (mEq/L)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Potassium: Milliequivalents per liter (mEq/L)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Chloride: Milliequivalents per liter (mEq/L)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Alanine Aminotransferase (ALT): Units per liter (U/L)
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)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Alkaline Phosphatase (ALP): Units per liter (U/L)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Total Bilirubin: Milligrams per deciliter (mg/dL)
Time frame: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Albumin: Grams per deciliter (g/dL)
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)
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)
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)
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).
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].
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.
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.
Institute for Digital Medicine (WisDM)
Other
Intermittent Fasting Monitoring for Human Optimization Utilizing Wearable Technology: an N-of-1 Prospective Study
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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