An interventional study of Burger and Daily blood microsampling in Healthy Participants, sponsored by Örebro University, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Screening
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.
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.
Örebro University, Sweden is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Burger · Device: Daily blood microsampling · Device: Daily glucose monitoring
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
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
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
Intra- and inter-individual metabolome variation
Evaluate intra- and interindividual short-term variability in blood-circulating metabolites of healthy individuals using minimally invasive blood collection methods and metabolomics.
Time frame: Four weeks
Postpradial blood circulating metabolites levels
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.
Time frame: Four weeks
Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood
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.
Time frame: four weeks
Started Jan 2026 (actual). Primary completion is estimated for May 2026, 4 months after the start.
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Örebro University, Sweden