Intermittent Fasting Monitoring for Human Optimization Utilizing Wearable Technology: an N-of-1 Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Metabolic biomarker analysis: apolipoprotein B (ApoB) levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •The principal investigator is the sole participant in this N-of-1 trial.
研究组 & 干预措施
Personalized Health Intervention Arm
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.
干预措施: Glucose-Ketone Index (GKI) monitoring (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Continuous Glucose Monitoring (CGM) (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Digital dynamometer (Other)
Personalized Health Intervention Arm
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.
干预措施: Wearables (Device)
Personalized Health Intervention Arm
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.
干预措施: Blood tests (Diagnostic Test)
Personalized Health Intervention Arm
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.
干预措施: Stool tests (Diagnostic Test)
Personalized Health Intervention Arm
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.
干预措施: Saliva tests (Diagnostic Test)
Personalized Health Intervention Arm
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.
干预措施: Fitness intervention (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Cold & heat intervention (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Airofit (Device)
Personalized Health Intervention Arm
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.
干预措施: 18h fasting (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: 48h fasting (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Three meal phase (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Mediterranean-inspired diet (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Supplements (Dietary Supplement)
Personalized Health Intervention Arm
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.
干预措施: Generative AI (Behavioral)
Personalized Health Intervention Arm
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.
干预措施: Interviews (Other)
结局指标
主要结局
Metabolic biomarker analysis: apolipoprotein B (ApoB) levels
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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: total cholesterol levels
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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: White Blood Cells (WBCs)
时间窗: 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)
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Hemoglobin (Hb): Grams per deciliter (g/dL)
Metabolic biomarker analysis: Aspartate Aminotransferase (AST)
时间窗: 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: Hematocrit (Hct)
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Hematocrit (Hct): Percentage (%)
Metabolic biomarker analysis: Alkaline Phosphatase (ALP)
时间窗: 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
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Total Bilirubin: Milligrams per deciliter (mg/dL)
Metabolic biomarker analysis: Platelets (PLT)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Sodium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Potassium
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Potassium: Milliequivalents per liter (mEq/L)
Metabolic biomarker analysis: Chloride
时间窗: 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)
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Alanine Aminotransferase (ALT): Units per liter (U/L)
Metabolic biomarker analysis: interleukin 10 (IL- 10) levels
时间窗: 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
时间窗: 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: Microtubule-associated protein 1A/1B-light chain 3 (LC3) levels
时间窗: 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
时间窗: 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
时间窗: 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: interleukin 17 (IL- 17) levels
时间窗: 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
时间窗: 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: Red Blood Cells (RBCs)
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Red Blood Cells (RBCs): Million cells per microliter (million/µL)
Wearable health metrics analysis for physiological monitoring
时间窗: 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
时间窗: 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.
Metabolic biomarker analysis: Albumin
时间窗: Pre and post 48 hour fasts (2 fasts per month for 12 months)
Albumin: Grams per deciliter (g/dL)
Microbial diversity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Dean Ho
Director of the N.1 Institute for Health
The N.1 Institute for Health (N.1)