Clinical trial NCT03830736: Health Effects of Oats and Oat Bioactive in Human
Official title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose Regulation
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Foundation for Strategic Research
First posted: 2019-02-05
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a randomized blinded cross-over study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood glucose regulation
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary outcomes:
measure: Serum insulin
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: plasma GLP-1 (glucagon-like peptide-1 )
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: IL (interleukin)-6
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Plasma PYY (peptide tyrosine tyrosine)
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: IL- 1beta
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Other outcomes:
measure: Subjective appetite sensations
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Breath hydrogen concentrations
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
measure: Mood (valence and activity)
timeFrame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Locations:
city: Lund
country: Sweden
facility: Food Technology, engineering and Nutrition, LTH, Lund University
Study officials:
affiliation: Lund University
name: Anne Nilsson
role: STUDY_CHAIR
References: