- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177172
Effect of Oat Compounds on Postprandial Glucose Response
January 20, 2022 updated by: Anne Nilsson, Lund University
Synergistic Effect of Oat Beta-glucans and Oat Polar Lipids on Postprandial Glucose Response
In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, 22100
- Lund University, Food Technology, Engineering and Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
- BMI 20-28 kg/m2
- Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)
Exclusion Criteria:
- fasting glucose > 6.1 mmol/L
- metabolic diseases
- gastrointestinal disease
- chronic and/or psychological disease
- food allergy
- Vegetarian or vegan diets, or other special diets
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Placebo Comparator: Control
White wheat flour bread
|
No beta glucans or polar lipids
|
|
Experimental: High betaglucans
White wheat flour bread included beta glucans with the highest amounts in this study
|
higher dose betaglucans
|
|
Experimental: Low beta glucans
White wheat flour bread included beta glucans with the lowest amounts in this study
|
lower dose beta glucans
|
|
Experimental: Low beta glucans + low polar lipids
White wheat flour bread included a combination of the lowest amounts of beta glucans and polar lipids
|
low dose betaglucans in a combination with low dose of polar lipids
|
|
Experimental: low polar lipids
White wheat flour bread included polar lipids
|
low dose polar lipids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose tolerance
Time Frame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
|
Postprandial glucose concentrations (mmol/L).
The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
|
3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite variables
Time Frame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
|
Postprandial sensation of hunger, satiety, and desire to eat will be determined with a 100 millimeter visual analogue scale (VAS).
The left end of the VAS scale represent "not at all" (e.g.
hungry) and right end of the scale represented "extremely".
One scale for each parameter will be used.
The total area under the curve will be calculated, and the results will be expressed as millimeter*minutes.
|
3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
January 19, 2022
Study Completion (Actual)
January 19, 2022
Study Registration Dates
First Submitted
December 1, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
January 4, 2022
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Scanoats
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Will be available after request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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