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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542265
Other study ID # Protokoll 2018/8b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2020
Est. completion date December 18, 2020

Study information

Verified date February 2021
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
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 December 18, 2020
Est. primary completion date December 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Combination Product:
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

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 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 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 (interleukin)-6 Inflammatory markers in blood 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary Serum triglycerides Cardiometabolic risk markers 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary Serum Free Fatty Acids Cardiometabolic risk markers 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
See also
  Status Clinical Trial Phase
Completed NCT05139355 - Health Effects of Oat and Oat Polar Lipids in Human N/A
Completed NCT03830736 - Health Effects of Oats and Oat Bioactive in Human N/A