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Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07527793
Acronym
MicroFastFood
Enrollment
35
Registered
2026-04-14
Start date
2026-01-21
Completion date
2026-12-31
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Metabolomics, lipidomics, mass spectrometry, microsampling

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTBurger

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

DEVICEDaily 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 - 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

DEVICEDaily 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

Sponsors

Örebro University, Sweden
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: 18-65 years old 2. Body Mass Index (BMI): 18.5-29.9 kg/m2 3. Weight stability within the previous 3 months (self-reported). 4. Positive intention to maintain usual routine physical activity and eating habits during the study.

Exclusion criteria

1. Presence of acute chronic diseases, inflammatory or functional gastrointestinal disorders, or any diagnosed disease condition that disrupt daily routine activities. 2. Routine use medications or supplements that could potentially interfere with the study outcomes 3. History of eating disorder 4. Recent use of antibiotic medication within the last 3 months prior to the first visit 5. Active efforts to lose weight 6. Smoking 7. Consumption of alcoholic drinks exceeding nine standard cups per week and/or more than three standard cups per occasion

Design outcomes

Primary

MeasureTime frameDescription
Intra- and inter-individual metabolome variationFour weeksEvaluate 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 levelsFour weeksDuring 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

MeasureTime frameDescription
Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Bloodfour weeksShort-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.

Countries

Sweden

Contacts

CONTACTAnh Hoang Nguyen, Ph.D.
anh-hoang.nguyen@oru.se+46723747116
PRINCIPAL_INVESTIGATORMatej Oresic, Ph.D.

School of Medical Sciences, Orebro University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026