Postprandial Metabolism in Healthy Young Subjects

NCT04989478 | Completed

• 1 other identifier: 236654
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Period; Biomarkers; Fasting

Keywords

Postprandial metabolism; Nutritional biomarker; Fasting

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (3)

• Sex differences

  24 hours

• Fasting vs nonfasting concentrations

  24 hours

• 12h fasting metabolomic profile after day vs night fast

  0 and 12 hours

Interventions

Fasting OTHER

After the standardized breakfast meal, all participants will only consume water for 24 hours

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Research Unit for Health Surveys, University of Bergen

Bergen, Vestland, 5009, Norway

Location

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 4, 2021
• Study Start: August 16, 2021
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone can access the data

Locations

NO (1)