Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Intra- and inter-individual metabolome variation
研究概览
简要总结
This study investigates short-term intra- and inter-individual variability in human blood metabolism under real-life conditions. Using minimally invasive finger-prick blood sampling, dietary records, and wearable devices, we will longitudinally monitor blood-circulating metabolites and glucose levels in healthy individuals over a four-week period without dietary or lifestyle intervention. The study focuses on metabolic transitions between pre- and postprandial states during habitual daily activities and routine meals. Mass spectrometry-based metabolomics will be used to characterize metabolite profiles and their associations with diet, physical activity, sleep, and stress. In parallel, the study evaluates the feasibility of microsampling approaches, wearable-derived physiological data, and isotope-labelled standards for robust and cost-effective metabolite quantification. The results will inform the design of larger longitudinal studies using minimally invasive blood sampling in non-controlled settings.
详细描述
Human metabolism is highly dynamic and continuously influenced by food intake, physical activity, sleep, stress, and other routine physiological factors. Following meal consumption, individuals enter a postprandial metabolic phase characterized by digestion, absorption, and metabolic handling of ingested nutrients. The magnitude and duration of postprandial metabolic responses vary substantially within and between individuals and reflect the individual capacity to maintain metabolic homeostasis. Although many metabolomics studies rely on controlled diets and fasting conditions to reduce variability, most individuals in Western societies spend the majority of their daily lives in a non-fasted, fed state. Therefore, understanding metabolic variability under routine, non-controlled conditions is essential for a more comprehensive characterization of human metabolism.
This pilot study aims to investigate short-term intra- and inter-individual variation in blood-circulating metabolites under real-life conditions. Healthy participants will be followed longitudinally over a four-week period without dietary or lifestyle intervention. Minimally invasive finger-prick blood sampling will be combined with dietary records and wearable devices to collect repeated metabolic and physiological measurements during habitual daily activities.
Blood glucose levels will be measured to capture postprandial responses, and finger-prick blood samples will be collected for mass spectrometry-based metabolomics analysis. Metabolite profiles will be examined in relation to recorded dietary intake, physical activity, sleep patterns, and self-reported stress levels. In addition to characterizing metabolic variability, the study will evaluate the feasibility of microsampling strategies and the integration of metabolomics data with wearable-derived physiological measures. From an analytical perspective, isotope-labelled standards will be applied to support robust and cost-effective quantification of circulating metabolites.
Overall, this study aims to generate methodological and biological variation insights that explore personalize metabolism and support the design of larger medium- and long-term longitudinal studies using minimally invasive blood sampling in non-controlled, real-world settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-65 years old
- •Body Mass Index (BMI): 18.5-29.9 kg/m2
- •Weight stability within the previous 3 months (self-reported).
- •Positive intention to maintain usual routine physical activity and eating habits during the study.
排除标准
- •Presence of acute chronic diseases, inflammatory or functional gastrointestinal disorders, or any diagnosed disease condition that disrupt daily routine activities.
- •Routine use medications or supplements that could potentially interfere with the study outcomes
- •History of eating disorder
- •Recent use of antibiotic medication within the last 3 months prior to the first visit
- •Active efforts to lose weight
- •Consumption of alcoholic drinks exceeding nine standard cups per week and/or more than three standard cups per occasion
研究组 & 干预措施
Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to
Participants will be screened before the study, and eligible individuals will begin at week +1. They will receive 52 microsampling kits to collect daily finger-prick blood samples before breakfast for 28 days, along with a wearable device to monitor sleep, stress, and physical activity.
Once per week, participants will record one habitual weekday lunch and collect additional blood samples at 15 min, 30 min, 1 h, 2 h, and 4 h after the meal, using a portable capillary glucose meter to measure glucose levels before and after eating.
In total, each participant will collect 52 blood microsamples over 28 days (28 fasting and 24 postprandial). Questionnaires on diet, exposures, food response, and physical activity will be completed at the start (day 0), mid-point (~day 14), and end (day 28) of the study.
干预措施: Burger (Dietary Supplement)
Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to
Participants will be screened before the study, and eligible individuals will begin at week +1. They will receive 52 microsampling kits to collect daily finger-prick blood samples before breakfast for 28 days, along with a wearable device to monitor sleep, stress, and physical activity.
Once per week, participants will record one habitual weekday lunch and collect additional blood samples at 15 min, 30 min, 1 h, 2 h, and 4 h after the meal, using a portable capillary glucose meter to measure glucose levels before and after eating.
In total, each participant will collect 52 blood microsamples over 28 days (28 fasting and 24 postprandial). Questionnaires on diet, exposures, food response, and physical activity will be completed at the start (day 0), mid-point (~day 14), and end (day 28) of the study.
干预措施: Daily blood microsampling (Device)
Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to
Participants will be screened before the study, and eligible individuals will begin at week +1. They will receive 52 microsampling kits to collect daily finger-prick blood samples before breakfast for 28 days, along with a wearable device to monitor sleep, stress, and physical activity.
Once per week, participants will record one habitual weekday lunch and collect additional blood samples at 15 min, 30 min, 1 h, 2 h, and 4 h after the meal, using a portable capillary glucose meter to measure glucose levels before and after eating.
In total, each participant will collect 52 blood microsamples over 28 days (28 fasting and 24 postprandial). Questionnaires on diet, exposures, food response, and physical activity will be completed at the start (day 0), mid-point (~day 14), and end (day 28) of the study.
干预措施: Daily glucose monitoring (Device)
结局指标
主要结局
Intra- and inter-individual metabolome variation
时间窗: Four weeks
Evaluate intra- and interindividual short-term variability in blood-circulating metabolites of healthy individuals using minimally invasive blood collection methods and metabolomics.
Postpradial blood circulating metabolites levels
时间窗: Four weeks
During the study, the participants will also be asked to provide, once a week, a dietary record of one habitual/non-controlled meal they had for lunch during a weekday and collect blood samples from finger prick at defined time points after the ingestion of the selected lunch meal (15 min, 30 min, 1 h, 2 h and 4 h). Participants will also receive a portable capillary glucose meter to measure glucose levels when collecting samples before and after the selected lunch meal. Metabolites (e.g., bile acids, amino acids) will be measured in the collected blood using mass spectrometry platform.
次要结局
- Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood(four weeks)
研究者
Matej Oresic
Professor
Örebro University, Sweden