Clinical trial NCT05511077: Biomarkers of Oat Product Intake: The BiOAT Marker Study
Official title: Biomarkers of Oat Product Intake: The BiOAT Marker Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Oatly Group Inc
First posted: 2022-08-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of avenanthramides and avenacosides and their metabolites.
timeFrame: 24 hours
measure: Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.
timeFrame: 24 hours
measure: Urine concentrations of avenanthramides and avenacosides and their metabolites
timeFrame: 8 hours
Secondary outcomes:
measure: Gut microbiome
timeFrame: 5 days
measure: Plasma metabolites
timeFrame: 5 days
measure: Urine metabolites
timeFrame: 24 hours
measure: Blood concentrations of avenanthramides and avenacosides and their metabolites
timeFrame: 8 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg, Department of Food and Nutrition and Sport Science
Study officials:
affiliation: Chalmers University of Technology
name: Rikard Landberg, Dr
role: PRINCIPAL_INVESTIGATOR
References: