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Postprandial Metabolism in Healthy Young Subjects (PoMet)

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ClinicalTrials.gov Identifier: NCT04989478
Recruitment Status : Completed
First Posted : August 4, 2021
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
University of Bergen

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Postprandial Period Biomarkers Fasting Other: Fasting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Postprandial Metabolism in Healthy Young Subjects
Actual Study Start Date : August 16, 2021
Actual Primary Completion Date : November 9, 2021
Actual Study Completion Date : November 9, 2021

Intervention Details:
  • Other: Fasting
    After the standardized breakfast meal, all participants will only consume water for 24 hours


Primary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. Sex differences [ Time Frame: 24 hours ]
    Comparison of metabolite concentrations between male and female subjects

  2. Fasting vs nonfasting concentrations [ Time Frame: 24 hours ]
    Comparison according to conventional cutoffs of fasting status (>6 and >8 hours)

  3. 12h fasting metabolomic profile after day vs night fast [ Time Frame: 0 and 12 hours ]
    Compare 12h fasting concentrations after an overnight fast to 12h fasting concentrations after day fasting



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04989478


Locations
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Norway
Research Unit for Health Surveys, University of Bergen
Bergen, Vestland, Norway, 5009
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT04989478    
Other Study ID Numbers: 236654
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified raw data will be deposited in a national research data repository (dataverse.no)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Immediately following publication. No end date.
Access Criteria: Anyone can access the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bergen:
Postprandial metabolism
Nutritional biomarker
Fasting