Healthy ParticipantsMicroFastFoodNCT07527793
Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques
A study testing Burger, Daily blood microsampling and Daily glucose monitoring in people with Healthy Participants, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Burger, Daily blood microsampling and Daily glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
School of Medical Sciences
Örebro, 70281
Anh Hoang Nguyen, Ph.D., +46723747116, anh-hoang.nguyen@oru.se
Matej Oresic, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Burger, Daily blood microsampling, Daily glucose monitoring
- Keywords
- Metabolomics, lipidomics, mass spectrometry, microsampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurgerDietary 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 microsamplingDevice
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 monitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Burger; Device: Daily blood microsampling; Device: Daily glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start21 Jan 2026
- Primary completion25 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Oresic, Örebro University, Sweden
- Investigators
- Matej Oresic, Ph.D., Principal investigator, School of Medical Sciences, Orebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527793
- Sponsor's protocol ID
- Dnr 2025-01045-02
- Acronym
- MicroFastFood
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques
- ClinicalTrials.gov ID
- NCT07527793
- Acronym / sponsor ID
- MicroFastFood / Dnr 2025-01045-02
- Conditions
- Healthy Participants
- Keywords
- Metabolomics, lipidomics, mass spectrometry, microsampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to | Experimental | Dietary Supplement: Burger, Device: Daily blood microsampling, Device: Daily glucose monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BurgerEach 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 | Dietary supplement | Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to |
| Daily blood microsamplingFinger-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 | Device | Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to |
| Daily glucose monitoringAn 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 | Device | Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to |
Primary outcome
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.
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.
1 secondary outcome
Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood
Time frame: four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Related trials for Healthy Participants
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matej Oresic, Ph.D. principal investigator
School of Medical Sciences, Orebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burger, Daily blood microsampling and Daily glucose monitoring in people with Healthy Participants, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anh Hoang Nguyen, Ph.D. (+46723747116, anh-hoang.nguyen@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- and inter-individual metabolome variation (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.