Health Effects of Oats and Oat Bioactive in Human

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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glucose Regulation
• Intervention / Treatment: Combination product: Control product; Combination product: Oat Beverage 1; Combination product: Oat Beverage 2; Combination product: Oat Beverage 3; Combination product: Oat Beverage 4

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Food Technology, engineering and Nutrition, LTH, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control product; A glucose solution (glucose and water) based on 42 gram carbohydrates.	Combination product: Control product; Glucose based beverage without added test components is used as control product
Experimental: 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.	Combination product: Oat Beverage 1; Oat based beverage with added different concentration of extracted oat component.
Experimental: 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.	Combination product: Oat Beverage 2; Oat based beverage with added different concentration of extracted oat component.
Experimental: 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.	Combination product: Oat Beverage 3; Oat based beverage with added different concentration of extracted oat component.
Experimental: 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.	Combination product: Oat Beverage 4; Oat based beverage with added different concentration of extracted oat component.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose regulation	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.	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum insulin	Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
plasma GLP-1 (glucagon-like peptide-1 )	Gastro-intestinale hormones involved in appetite and metabolic regulation	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Plasma PYY (peptide tyrosine tyrosine)	Gastro-intestinale hormones involved in appetite and metabolic regulation	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
IL (interleukin)-6	Inflammatory markers in blood	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
IL- 1beta	Inflammatory markers in blood	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite sensations	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)	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Mood (valence and activity)	Determined with VAS (visual analogue scale) scales 0-100 mm	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Breath hydrogen concentrations	Indicator of gut fermentation	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Swedish Foundation for Strategic Research
• Investigators: Study Chair: Anne Nilsson, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Protokoll 2018/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No