Health Effects of Oats and Oat Bioactive in Human

Postprandial Glucose Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830736
• Other study ID #: Protokoll 2018/8
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postprandial Glucose Regulation

Intervention

Combination Product:
• Oat Beverage 1
Oat based beverage with added different concentration of extracted oat component.
• Oat Beverage 2
Oat based beverage with added different concentration of extracted oat component.
• Oat Beverage 3
Oat based beverage with added different concentration of extracted oat component.
• Oat Beverage 4
Oat based beverage with added different concentration of extracted oat component.
• Control product
Glucose based beverage without added test components is used as control product

Locations

Country	Name	City	State
Sweden	Food Technology, engineering and Nutrition, LTH, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Swedish Foundation for Strategic Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Breath hydrogen concentrations	Indicator of gut fermentation	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	IL (interleukin)-6	Inflammatory markers in blood	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary	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)
Secondary	IL- 1beta	Inflammatory markers in blood	0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)