Biomarkers of Oat Product Intake: The BiOAT Marker Study

Healthy Clinical Trial

Official title:

Biomarkers of Oat Product Intake: The BiOAT Marker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511077
• Other study ID #: ChalmersU
• Status: Completed
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: December 19, 2022

Study information

• Verified date: February 2023
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Sweden	University of Gothenburg, Department of Food and Nutrition and Sport Science	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Chalmers University of Technology	Oatly Group Inc

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products.	5 days
Secondary	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
Secondary	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
Secondary	Blood concentrations of avenanthramides and avenacosides and their metabolites	Evaluate new simple sampling techniques using dried blood spots.	8 hours