- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527793
Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques (MicroFastFood)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anh Hoang Nguyen, Ph.D.
- Phone Number: +46723747116
- Email: anh-hoang.nguyen@oru.se
Study Locations
-
-
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Örebro, Sweden, 70281
- Recruiting
- School of Medical Sciences
-
Contact:
- Anh Hoang Nguyen, Ph.D.
- Phone Number: +46723747116
- Email: anh-hoang.nguyen@oru.se
-
Principal Investigator:
- Matej Oresic, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessment of Daily Variability in Exposomics and Metabolomics and Associated Metabolic Responses to
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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Four weeks
|
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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.
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Measurement of Short-Chain Fatty Acids and Tryptophan-Derived Metabolites in Blood
Time Frame: four weeks
|
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.
|
four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matej Oresic, Ph.D., School of Medical Sciences, Orebro University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dnr 2025-01045-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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