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Health Effects of Oats and Oat Bioactive in Human

Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03830736
Enrollment
24
Registered
2019-02-05
Start date
2019-02-18
Completion date
2019-12-30
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Glucose Regulation

Brief summary

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

Detailed description

The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Interventions

COMBINATION_PRODUCTOat Beverage 1

Oat based beverage with added different concentration of extracted oat component.

COMBINATION_PRODUCTOat Beverage 2

Oat based beverage with added different concentration of extracted oat component.

COMBINATION_PRODUCTOat Beverage 3

Oat based beverage with added different concentration of extracted oat component.

COMBINATION_PRODUCTOat Beverage 4

Oat based beverage with added different concentration of extracted oat component.

COMBINATION_PRODUCTControl product

Glucose based beverage without added test components is used as control product

Sponsors

Swedish Foundation for Strategic Research
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

a randomized blinded cross-over study

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy adults * BMI 18,5 - 25 * non smokers * consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion criteria

* Fasting blood glucose concentration \>6.1 mmol/l * known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose regulation0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.

Secondary

MeasureTime frameDescription
IL (interleukin)-60 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Inflammatory markers in blood
Serum insulin0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.
Plasma PYY (peptide tyrosine tyrosine)0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Gastro-intestinale hormones involved in appetite and metabolic regulation
IL- 1beta0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Inflammatory markers in blood
plasma GLP-1 (glucagon-like peptide-1 )0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Gastro-intestinale hormones involved in appetite and metabolic regulation

Other

MeasureTime frameDescription
Mood (valence and activity)0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Determined with VAS (visual analogue scale) scales 0-100 mm
Breath hydrogen concentrations0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Indicator of gut fermentation
Subjective appetite sensations0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)Determined with VAS (visual analogue scale) scales (0-100 mm) as a range of subjective sensations related to appetite (such as hunger, desire to eat or fullness)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026