Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques

NCT07527793 | Recruiting

• 1 other identifier: Dnr 2025-01045-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Metabolomics, lipidomics, mass spectrometry, microsampling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Four weeks

Secondary Outcomes (1)

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

  four weeks

Study Arms (1)

Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to

EXPERIMENTAL

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

Interventions

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

Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to

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

Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to

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

Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

School of Medical Sciences

Örebro, 70281, Sweden

RECRUITING

Study Officials

• Matej Oresic, Ph.D.

  School of Medical Sciences, Orebro University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anh Hoang Nguyen, Ph.D.

CONTACT

+46723747116; anh-hoang.nguyen@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-02

Locations

SE (1)