Health Effects of Oat and Oat Bioactive in Human

Dose Response Effects of Oat Bioactive in Healthy Adults

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: Effects of Oat and Oat Components on Cardiometabolic risk variables

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): 20
• 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 - 28
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oat product 1; The test portion is based on 50 gram available carbohydrates with added vegetable oil A. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.	Combination product: Effects of Oat and Oat Components on Cardiometabolic risk variables; Oat and oat bioactive components consumed as breakfast meal.
Experimental: Oat product 2; The test portion is based on 50 gram available carbohydrates with added vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.	Combination product: Effects of Oat and Oat Components on Cardiometabolic risk variables; Oat and oat bioactive components consumed as breakfast meal.
Experimental: Oat product 3; The test portion is based on 50 gram available carbohydrates with added vegetable oil A + vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.	Combination product: Effects of Oat and Oat Components on Cardiometabolic risk variables; Oat and oat bioactive components consumed as breakfast meal.
Placebo Comparator: Control Product; The test portion is based on 50 gram available carbohydrates without added vegetable oil. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning.	Combination product: Effects of Oat and Oat Components on Cardiometabolic risk variables; Oat and oat bioactive components consumed as breakfast meal.

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)
Serum triglycerides	Cardiometabolic risk markers	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Serum Free Fatty Acids	Cardiometabolic risk markers	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)

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)

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Swedish Foundation for Strategic Research

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Protokoll 2018/8b

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