- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801653
Health Effects of Oat Bioactives (Betaglucan) in Human
Health Effects of Oat and Oat Bioactives in Human
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skane
-
Lund, Skane, Sweden, 22100
- Food Technology, engineering and Nutrition, LTH, Lund University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oat meal 1
The test portion is based on 30 gram available carbohydrates with added x amount oat betaglucan.
Test portion consumed as a breakfast meal prior to determinations of test variables in the morning
|
Oat and oat bioactive components consumed as breakfast meal.
|
Experimental: Oat meal 2
The test portion is based on 30 gram available carbohydrates with added y amount of oat betaglucan.
Test portion consumed as a breakfast meal prior to determinations of test variables in the morning
|
Oat and oat bioactive components consumed as breakfast meal.
|
Experimental: Oat meal 3
The test portion is based on 30 gram available carbohydrates with added z amount of oat betaglucan.
Test portion consumed as a breakfast meal prior to determinations of test variables in the morning
|
Oat and oat bioactive components consumed as breakfast meal.
|
Placebo Comparator: Reference
The test portion is based on 30 gram available carbohydrates without added oat betaglucan.
Test portion consumed as a breakfast meal prior to determinations of test variables in the morning
|
Oat and oat bioactive components consumed as breakfast meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose regulation
Time Frame: Time Frame: 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.
|
Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum insulin
Time Frame: Time Frame: 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.
|
Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite sensations
Time Frame: Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Nilsson, Department of Food Technology, Engineering and Nutrition, Lund Univesity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dnr. 2018/658 (del 4)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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