Health Effects of Oats and Oat Bioactive in Human

NCT ID: NCT03830736

Last Updated: 2020-05-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-12-30

Brief Summary

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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

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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

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Postprandial Glucose Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

a randomized blinded cross-over study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control product

A glucose solution (glucose and water) based on 42 gram carbohydrates.

Group Type PLACEBO_COMPARATOR

Control product

Intervention Type COMBINATION_PRODUCT

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

Oat Beverage 1

The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.

Group Type EXPERIMENTAL

Oat Beverage 1

Intervention Type COMBINATION_PRODUCT

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

Oat Beverage 2

The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.

Group Type EXPERIMENTAL

Oat Beverage 2

Intervention Type COMBINATION_PRODUCT

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

Oat Beverage 3

The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.

Group Type EXPERIMENTAL

Oat Beverage 3

Intervention Type COMBINATION_PRODUCT

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

Oat Beverage 4

The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.

Group Type EXPERIMENTAL

Oat Beverage 4

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Oat Beverage 1

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

Intervention Type COMBINATION_PRODUCT

Oat Beverage 2

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

Intervention Type COMBINATION_PRODUCT

Oat Beverage 3

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

Intervention Type COMBINATION_PRODUCT

Oat Beverage 4

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

Intervention Type COMBINATION_PRODUCT

Control product

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Foundation for Strategic Research

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Anne Nilsson

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Nilsson

Role: STUDY_CHAIR

Lund University

Locations

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Food Technology, engineering and Nutrition, LTH, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Protokoll 2018/8

Identifier Type: -

Identifier Source: org_study_id

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