Health Effects of Oat Bioactives (Betaglucan) in Human

NCT ID: NCT05801653

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oat meal 1

The test portion is based on 30 gram available carbohydrates with added x amount oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Group Type EXPERIMENTAL

Effects of Oat and Oat Components on Cardiometabolic risk variables

Intervention Type DIETARY_SUPPLEMENT

Oat and oat bioactive components consumed as breakfast meal.

Oat meal 2

The test portion is based on 30 gram available carbohydrates with added y amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Group Type EXPERIMENTAL

Effects of Oat and Oat Components on Cardiometabolic risk variables

Intervention Type DIETARY_SUPPLEMENT

Oat and oat bioactive components consumed as breakfast meal.

Oat meal 3

The test portion is based on 30 gram available carbohydrates with added z amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Group Type EXPERIMENTAL

Effects of Oat and Oat Components on Cardiometabolic risk variables

Intervention Type DIETARY_SUPPLEMENT

Oat and oat bioactive components consumed as breakfast meal.

Reference

The test portion is based on 30 gram available carbohydrates without added oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning

Group Type PLACEBO_COMPARATOR

Effects of Oat and Oat Components on Cardiometabolic risk variables

Intervention Type DIETARY_SUPPLEMENT

Oat and oat bioactive components consumed as breakfast meal.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Effects of Oat and Oat Components on Cardiometabolic risk variables

Oat and oat bioactive components consumed as breakfast meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Healthy adults BMI 18.5 - 28 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

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.

No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swedish Foundation for Strategic Research

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne Nilsson

Role: PRINCIPAL_INVESTIGATOR

Department of Food Technology, Engineering and Nutrition, Lund Univesity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dnr. 2018/658 (del 4)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oat Phenolics Bioavailability
NCT02574039 COMPLETED NA