Postprandial PeriodPoMetNCT04989478
Postprandial Metabolism in Healthy Young Subjects
A study testing Fasting in people with Postprandial Period and Biomarkers, run by University of Bergen at 1 site in Norway.
Trial summary
This study aims to describe the dynamic changes in nutritional biomarkers in the blood during the postprandial period, i.e. the time period from the last meal and into the fasting state. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Period, Biomarkers, Fasting
- What is being tested?
- Fasting
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- 16 Aug 2021to 9 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 22-27 kg/m^2
- No significant weight change (>5%) during the last 3 months before the study visit
- Female participants should use one of the following oral contraceptives: Almina, Loette, Melleva, Microgynon, Mirabella, or Oralcon
Who cannot join
- Acute or chronic disease such as diabetes, thyroid diseases, cancer, cardiovascular disease, or inflammatory bowel disease, during the last 3 years
- Celiac disease or other food allergies interfering with the standardized breakfast meal
- Use of any prescription medications
- Smoking or regular use of other nicotine-containing products
- Pregnancy or breastfeeding the last 3 months
Trial locations and contacts
1 site in 1 country.
Norway1 site
Research Unit for Health Surveys, University of Bergen
Bergen, Vestland, 5009
About this study
This study aims to describe the dynamic changes in nutritional biomarkers in the blood during the postprandial period, i.e. the time period from the last meal and into the fasting state. In total 36 healthy, young men and women will be recruited in Bergen, Norway, and after receiving a standardized breakfast meal they will consume only water for the next 24 hours.
Read the detailed description
Throughout the day, humans switch back and forth between the fed, postprandial (after a meal), and the postabsorptive (fasting) metabolic state. This is followed by a shift in fuel utilization from primarily using glucose to predominantly rely on β-oxidation of fatty acids. Consequently, circulating concentrations of biomarkers may fluctuate in response to this changing metabolic state. Much is known about the hormonal and metabolic effects of fasting, including lower insulin secretion, increased release of free fatty acids from adipose tissue, increased ketogenesis, glycogen breakdown, and activated gluconeogenesis. However, less is known about the effect on other biochemical markers in the postabsorptive period.
When evaluating nutritional biomarkers, both in clinical practice and in research, it is common practice to distinguish between fasting or non-fasting blood samples, based on time since the last meal. The extent to which different biomarkers are influenced by fasting status vary, and accordingly, several diagnostic cutoffs, e.g. plasma glucose for diabetes diagnosis, vary according to whether the sample was fasting or not. However, as the adaptation to fasting is a gradual process, it is expected that any changes in biomarker concentrations are also gradual. Further, as circulating metabolite concentrations are determined as a result of input (intestinal absorption and release from tissues), metabolism, and removal (utilization, storage, and excretion), we cannot reasonably assume that these changes are linear.
A few previous studies have aimed at describing the dynamics of fasting metabolism, demonstrating that the circulating metabolome changes during prolonged fasting in a dynamic manner. However, as data collection started after an overnight fast period, these studies do not provide data on the initial postprandial period and the adaptation to the fasting state. This study will extend the knowledge on the dynamics of human postprandial metabolism, by monitoring circulating concentrations of biomarkers during the 24 hours after a standardized breakfast meal. The investigators aim to capture the adaptation period from the fed to the fasting state and provide time-resolved data on a broad range of nutritional biomarkers.
Enrolled participants will attend the study center after an overnight fast, following a standardized evening meal consumed 12 hours before attendance. Anthropometric measurements (body weight, height, waist circumference, and body composition) will be taken in the fasting state, and a fasting blood sample will be drawn. After completing a standardized breakfast meal, the participants will remain at the study center for 12 hours, and blood will be frequently collected at specified time points. The participants will return to the study center the following morning for a final 24h fasting blood sample.
- Conditions
- Postprandial Period, Biomarkers, Fasting
- Being tested
- Fasting
- Keywords
- Postprandial metabolism, Nutritional biomarker, Fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
After the standardized breakfast meal, all participants will only consume water for 24 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics profile in serum during 24 hour fasting
Targeted metabolomics analyses of nutritional biomarkers related to B-vitamin status, one-carbon metabolism, and amino acids. All metabolite concentrations (Individual data + group geometric mean) will be presented for 14 prespecified timepoints after a standardized breakfast meal (15m, 30m, 45m, 60m, 90m, 2h, 3h, 4h, 6h. 8h, 10h, 12h, and 24h).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start16 Aug 2021
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial PeriodStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989478
- Sponsor's protocol ID
- 236654
- Acronym
- PoMet
- Status last verified
- Jan 2022
- First submitted
- 5 Jul 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified raw data will be deposited in a national research data repository (dataverse.no)
Publications
Anfinsen AM, Myklebust VH, Johannesen CO, Christensen JJ, Laupsa-Borge J, Dierkes J, Nygard O, McCann A, Rosendahl-Riise H, Lysne V. Serum concentrations of lipids, ketones and acylcarnitines during the postprandial and fasting state: the Postprandial Metabolism (PoMet) study in healthy young adults. Br J Nutr. 2024 Oct 14;132(7):851-861. doi: 10.1017/S0007114524001934. Epub 2024 Oct 18.
PubMed 39422147
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Metabolism in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT04989478
- Acronym / sponsor ID
- PoMet / 236654
- Conditions
- Postprandial Period, Biomarkers, Fasting
- Keywords
- Postprandial metabolism, Nutritional biomarker, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 4 Aug 2021 (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 aims to describe the dynamic changes in nutritional biomarkers in the blood during the postprandial period, i.e. the time period from the last meal and into the fasting state. In total 36 healthy, young men and women will be recruited in Bergen, Norway, and after receiving a standardized breakfast meal they will consume only water for the next 24 hours.
Detailed description
Throughout the day, humans switch back and forth between the fed, postprandial (after a meal), and the postabsorptive (fasting) metabolic state. This is followed by a shift in fuel utilization from primarily using glucose to predominantly rely on β-oxidation of fatty acids. Consequently, circulating concentrations of biomarkers may fluctuate in response to this changing metabolic state. Much is known about the hormonal and metabolic effects of fasting, including lower insulin secretion, increased release of free fatty acids from adipose tissue, increased ketogenesis, glycogen breakdown, and activated gluconeogenesis. However, less is known about the effect on other biochemical markers in the postabsorptive period.
When evaluating nutritional biomarkers, both in clinical practice and in research, it is common practice to distinguish between fasting or non-fasting blood samples, based on time since the last meal. The extent to which different biomarkers are influenced by fasting status vary, and accordingly, several diagnostic cutoffs, e.g. plasma glucose for diabetes diagnosis, vary according to whether the sample was fasting or not. However, as the adaptation to fasting is a gradual process, it is expected that any changes in biomarker concentrations are also gradual. Further, as circulating metabolite concentrations are determined as a result of input (intestinal absorption and release from tissues), metabolism, and removal (utilization, storage, and excretion), we cannot reasonably assume that these changes are linear.
A few previous studies have aimed at describing the dynamics of fasting metabolism, demonstrating that the circulating metabolome changes during prolonged fasting in a dynamic manner. However, as data collection started after an overnight fast period, these studies do not provide data on the initial postprandial period and the adaptation to the fasting state. This study will extend the knowledge on the dynamics of human postprandial metabolism, by monitoring circulating concentrations of biomarkers during the 24 hours after a standardized breakfast meal. The investigators aim to capture the adaptation period from the fed to the fasting state and provide time-resolved data on a broad range of nutritional biomarkers.
Enrolled participants will attend the study center after an overnight fast, following a standardized evening meal consumed 12 hours before attendance. Anthropometric measurements (body weight, height, waist circumference, and body composition) will be taken in the fasting state, and a fasting blood sample will be drawn. After completing a standardized breakfast meal, the participants will remain at the study center for 12 hours, and blood will be frequently collected at specified time points. The participants will return to the study center the following morning for a final 24h fasting blood sample.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index between 22-27 kg/m^2
- No significant weight change (>5%) during the last 3 months before the study visit
- Female participants should use one of the following oral contraceptives: Almina, Loette, Melleva, Microgynon, Mirabella, or Oralcon
Key exclusion criteria (5 listed)
- Acute or chronic disease such as diabetes, thyroid diseases, cancer, cardiovascular disease, or inflammatory bowel disease, during the last 3 years
- Celiac disease or other food allergies interfering with the standardized breakfast meal
- Use of any prescription medications
- Smoking or regular use of other nicotine-containing products
- Pregnancy or breastfeeding the last 3 months
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 |
|---|---|---|
| FastingAfter the standardized breakfast meal, all participants will only consume water for 24 hours | Other | – |
Primary outcome
Metabolomics profile in serum during 24 hour fasting
Time frame: 24 hours
Targeted metabolomics analyses of nutritional biomarkers related to B-vitamin status, one-carbon metabolism, and amino acids. All metabolite concentrations (Individual data + group geometric mean) will be presented for 14 prespecified timepoints after a standardized breakfast meal (15m, 30m, 45m, 60m, 90m, 2h, 3h, 4h, 6h. 8h, 10h, 12h, and 24h).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 39422147Anfinsen AM, Myklebust VH, Johannesen CO, Christensen JJ, Laupsa-Borge J, Dierkes J, Nygard O, McCann A, Rosendahl-Riise H, Lysne V. Serum concentrations of lipids, ketones and acylcarnitines during the postprandial and fasting state: the Postprandial Metabolism (PoMet) study in healthy young adults. Br J Nutr. 2024 Oct 14;132(7):851-861. doi: 10.1017/S0007114524001934. Epub 2024 Oct 18.
- Individual participant dataSharing planned: Yes. Deidentified raw data will be deposited in a national research data repository (dataverse.no)
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Postprandial Period and Biomarkers, run by University of Bergen at 1 site in Norway.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jan 2022. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics profile in serum during 24 hour fasting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989478, which also lists 1 linked publication.
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 6 Jan 2022.