ClinicalTrials.Veeva

Menu

Biomarkers of Oat Product Intake: The BiOAT Marker Study

C

Chalmers University of Technology

Status

Completed

Conditions

Healthy

Treatments

Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05511077
ChalmersU

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

23 participants in 2 patient groups

Liquid oat product
Other group
Treatment:
Other: Diet
Solid oat product
Other group
Treatment:
Other: Diet

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems