NCT06630637 - Monitoring Intermittent Fasting for Human Optimization Using Wearable Technology: An N-of-1 Study | Crick

Interventions

Glucose-Ketone Index (GKI) monitoringBEHAVIORAL

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 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 interventionBEHAVIORAL

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

Cold & heat interventionBEHAVIORAL

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 fastingBEHAVIORAL

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 fastingBEHAVIORAL

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 phaseBEHAVIORAL

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

Mediterranean-inspired dietBEHAVIORAL

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 AIBEHAVIORAL

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.