Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Burger
  Each week, participants will eat one burger and collect finger blood before adn after consuming the burger 15 min, 30 min, 60 min, 120 min, 240 min
• Устройство Daily blood microsampling
  Finger-prick will be performed using a disposable pressure-activated lancet (Sterilance Press II, Vitrex; 21G, 2.8 mm incision) on which the lancet cannot be reactivated, and it returns to a safe plastic compartment after puncture. This mechanism reduces biohazard risks and risk of needlestick injuries. The finger-prick blood samples will be collected using a Capitainer quantitative dry blood spot (qDBS) micro sampling device (Capitainer). The total amount of blood obtained per time will be 20 -
• Устройство Daily glucose monitoring
  An automatic glucose readings will be attached to participant to monitor daily glucose levels. Data will be acquired by the sensor and shared with the researcher

Первичные конечные точки

• Intra- and inter-individual metabolome variation [Срок оценки: Four weeks]
• Postpradial blood circulating metabolites levels [Срок оценки: Four weeks]

Вторичные конечные точки (1)

• Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood [Срок оценки: four weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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
• Smoking
• Consumption of alcoholic drinks exceeding nine standard cups per week and/or more than three standard cups per occasion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Швеция · 1 центр

• School of Medical Sciences — Örebro

Идентификаторы

NCT: NCT07527793 · Dnr 2025-01045-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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