Health Effects of Oat Bioactives (Betaglucan) in Human

Healthy Clinical Trial

Official title:

Health Effects of Oat and Oat Bioactives in Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801653
• Other study ID #: Dnr. 2018/658 (del 4)
• Status: Completed
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: October 2023
• 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: 20
• Est. completion date: August 10, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adults BMI 18.5 - 28 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

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.

No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Effects of Oat and Oat Components on Cardiometabolic risk variables
Oat and oat bioactive components consumed as breakfast meal.

Locations

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

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)	Time Frame: 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.	Time Frame: 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.	Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)