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NCT Number: NCT07527793

Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medical Sciences

Örebro, 70281, Sweden

Location status: Recruiting

Location contact

Anh Hoang Nguyen, Ph.D.

CONTACT

[email protected]

+46723747116

Matej Oresic, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Burger

Dietary Supplement

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

Daily blood microsampling

Device

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 - 100 µL. The micro sampling device has two inlet ports, and when a drop of blood encounters the inlet port of the device, blood flows by capillary forces in a microchannel and 10 -50 µL of blood is absorbed in a pre-perforated paper disk. This principle allows the collection of a fixed volume of blood and overcomes the hematocrit bias.

Metabolite in microsamples will be extracted and analyzed using LC-MS platforms

Daily glucose monitoring

Device

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

Primary outcomes

  1. Intra- and inter-individual metabolome variation

    Time frame: Four weeks

    Evaluate intra- and interindividual short-term variability in blood-circulating metabolites of healthy individuals using minimally invasive blood collection methods and metabolomics.

  2. Postpradial blood circulating metabolites levels

    Time frame: 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.

Secondary outcomes

  1. Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood

    Time frame: four weeks

    Short-chain fatty acids (SCFAs) and related microbial metabolites were measured following burger consumption. Primary outcome metabolites included SCFAs as well as tryptophan-derived metabolites such as indole compounds. These metabolites were quantified in blood samples collected from participants over a 4-hour postprandial period after the meal using liquid chromatography-mass spectrometry (LC-MS)-based analytical platforms.

Study contacts

Contact information is provided by the study sponsor or research team.

Anh Hoang Nguyen, Ph.D.

CONTACT

[email protected]

+46723747116

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Acronym: MicroFastFood

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

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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