Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorÖrebro University, Sweden

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses toExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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

Other outcomes

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