Biomarkers of Oat Product Intake: The BiOAT Marker Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Liquid oat product	Other: Diet; Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.
Other: Solid oat product	Other: Diet; Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products.	5 days
Plasma metabolites	Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake. Baseline compared with after intervention products.	5 days
Urine metabolites	Untargeted metabolomics will be performed using established methods for urine. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake.	24 hours
Blood concentrations of avenanthramides and avenacosides and their metabolites	Evaluate new simple sampling techniques using dried blood spots.	8 hours

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Collaborators: Oatly Group Inc
• Investigators: Principal Investigator: Rikard Landberg, Dr, Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ChalmersU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No