Postprandial Metabolism in Healthy Young Subjects

Fasting Clinical Trial

— PoMet  

Official title:

Postprandial Metabolism in Healthy Young Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989478
• Other study ID #: 236654
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: November 9, 2021

Study information

• Verified date: January 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Fasting
• Postprandial Period

Intervention

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

Locations

Country	Name	City	State
Norway	Research Unit for Health Surveys, University of Bergen	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex differences	Comparison of metabolite concentrations between male and female subjects	24 hours
Other	Fasting vs nonfasting concentrations	Comparison according to conventional cutoffs of fasting status (>6 and >8 hours)	24 hours
Other	12h fasting metabolomic profile after day vs night fast	Compare 12h fasting concentrations after an overnight fast to 12h fasting concentrations after day fasting	0 and 12 hours
Primary	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).	24 hours