NCT05511077

Brief Summary

The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

August 19, 2022

Last Update Submit

February 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Plasma concentrations of avenanthramides and avenacosides and their metabolites.

    Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period).

    24 hours

  • Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.

    Differences in plasma AUCs between the intake levels for each biomarker candidate.

    24 hours

  • Urine concentrations of avenanthramides and avenacosides and their metabolites

    Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period).

    8 hours

Secondary Outcomes (4)

  • Gut microbiome

    5 days

  • Plasma metabolites

    5 days

  • Urine metabolites

    24 hours

  • Blood concentrations of avenanthramides and avenacosides and their metabolites

    8 hours

Study Arms (2)

Liquid oat product

OTHER
Other: Diet

Solid oat product

OTHER
Other: Diet

Interventions

DietOTHER

Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.

Liquid oat productSolid oat product

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females and males
  • Age 18-80 years
  • Body mass index (BMI) 18.5-30 kg/m2
  • Fasting glucose ≤ 6.1 mmol/l
  • Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
  • Triglycerides ≤ 2.60 mmol/L
  • Signed informed consent

You may not qualify if:

  • Food allergies or intolerances preventing consumption of any products included in the study.
  • Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
  • Pregnant, lactating or planning a pregnancy during the study period.
  • Antibiotic use for the last 3 months.
  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
  • History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
  • Previous major gastrointestinal surgery
  • Have type I diabetes
  • Thyroid disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg, Department of Food and Nutrition and Sport Science

Gothenburg, Sweden

Location

Related Publications (1)

  • Armeni M, Cardilin T, Fristedt R, Karlsson T, Jenkins CO, Nordin E, Qin P, Jirstrand M, Kristiansen K, Savolainen O, Landberg R. Avenanthramides and avenacosides as biomarkers of oat intake: a pharmacokinetic study of solid and liquid oat consumption under single and repeated dose conditions. Nutr J. 2025 Sep 9;24(1):136. doi: 10.1186/s12937-025-01204-7.

    PMID: 40926245DERIVED

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rikard Landberg, Dr

    Chalmers University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

September 9, 2022

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)