Health Effects of Oat and Oat Bioactive in Human

Not Applicable

Completed

• Conditions: Postprandial Glucose Regulation
• Interventions: Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables

• Registration Number: NCT04542265
• Lead Sponsor: Lund University

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.

Study Timeline

• Study Start: 2020-08-28
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-09
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oat product 3	Effects of Oat and Oat Components on Cardiometabolic risk variables	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.
Oat product 2	Effects of Oat and Oat Components on Cardiometabolic risk variables	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.
Oat product 1	Effects of Oat and Oat Components on Cardiometabolic risk variables	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.
Control Product	Effects of Oat and Oat Components on Cardiometabolic risk variables	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.

Primary Outcome Measures

Name	Time	Method
Blood glucose regulation	0 - 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 Outcome Measures

Name	Time	Method
IL (interleukin)-6	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)	Inflammatory markers in blood
Serum Free Fatty Acids	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)	Cardiometabolic risk markers
Serum insulin	0 - 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 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
Serum triglycerides	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)	Cardiometabolic risk markers
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

Trial Locations

Locations (1)

Food Technology, engineering and Nutrition, LTH, Lund University; 🇸🇪 Lund, Sweden