How Healthy Are Your Oats?

NCT07050680 | Active Not Recruiting

• 1 other identifier: 2-037-25
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Oat foods are commonly consumed as healthy breakfast options and their nutritional value is well recognised. Oats are a rich source of fibre, micronutrients and non-nutrient bioactive compounds, but at the same time cereals including oats can be contaminated with mycotoxins. To fully understand the nutritional benefits and potential food safety risks of oat consumption, this study aims to assess the nutritional composition of an oat food and the bioavailability of bioactive oat constituents and their metabolite profile in urine of volunteers consuming a single portion of an oat breakfast. This study requires 16 healthy volunteers to consume one portion of oats and collect their urine over 48 hours after the test meal. No other sample collection is required.

Conditions

Mycotoxin Biomonitoring

Keywords

Human exposure; Toxicokinetics; Urinary excretion

Outcome Measures

Primary Outcomes (1)

• Kinetics of mycotoxin absorption and excretion

  Urinary excretion profile of oat-derived mycotoxins and metabolites will be assessed after consumption of a single oat-based test meal in 16 volunteers. Volunteers will collect hourly urine samples. Samples will be analysed for mycotoxin metabolites using established LC-MS/MS methodology.

  Hourly urine sample collection up to 16 hours post-intervention, then bulk urine collection at 24 and 48 hours.

Study Arms (1)

Oat intervention arm

EXPERIMENTAL

All participants will consume a single dose of an oat test meal

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Single dose of commercially available Oat food test meal

Oat intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females (aged 18 - 65 years) who are healthy with a BMI in the normal to overweight range (18.5-29.9)

You may not qualify if:

• Anyone who currently suffers from gastrointestinal or metabolic diseases, liver disease or kidney disease
• Anyone who currently has an eating disorder (anorexia, bulimia, binge eating, night eating syndrome)
• Anyone who is taking prescribed medication related to gastrointestinal, metabolic, liver or kidney disease
• Anyone who has taken antibiotics in the past 3 months
• Anyone who is allergic or intolerant to oat foods
• Anyone who is currently pregnant or breastfeeding
• Anyone who is currently taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2 weeks before the study)
• Anyone currently participating in another research study
• Anyone who is unable to fluently speak, read and understand English
• Anyone who is unable to give written informed consent

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute, University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 3, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)