Effect of oat-containing biscuit on sugar metabolism
| ISRCTN | ISRCTN10440291 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10440291 |
- Submission date
- 20/09/2023
- Registration date
- 07/11/2023
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Oat is believed to provide health benefits. This study will examine how the ingestion of biscuits, containing beta-glycan fibers from oats, affects blood sugar by using a standard finger prick test for blood sugar.
Who can participate?
Healthy female volunteers aged between 20 and 40 years old
What does the study involve?
After oral intake of a beta-glycan-containing biscuit participants will be subjected to an oral glucose tolerance test (OGTT). The test involves the collection of capillary blood at regular intervals for 2 hours. After around one week the OGTT will be repeated, this time without intake of a biscuit. Testing will take a total of around 3 hours each time.
What are the possible benefits and risks of participating?
The participants will contribute to advanced research on metabolic regulation and this can be of future help for persons affected by diabetes. The risk from participation is negligible. The oat-containing biscuit is a normal nutrient and is not expected to cause any harm. The testing procedure involves blood sampling which can cause minor discomfort.
Where is the study run from?
The study will be run in Singapore by Temasek Polytechnic’s Glycemic Index Research Unit
When is the study starting and how long is it expected to run for?
December 2020 to December 2023
Who is funding the study?
Enterprise Singapore (Singapore)
Who is the main contact?
gunnar.norstedt@ki.se (Sweden)
Contact information
Principal Investigator
Karolinska Institute
Forfattarvagen 46
Bromma
16775
Sweden
| Phone | +46704848548 |
|---|---|
| gunnar.norstedt@ki.se |
Scientific
Glycemic Index Research Unit
Temasek Analytical Services Facility
East Wing Block 1A-01-83
21 Tampines Avenue 1
Tampines
529757
Singapore
| Phone | +65 6780 1849 |
|---|---|
| Kalpana_bhaskaran@tp.edu.sg |
Public
Gloobe PTE LTD
Farrer Road
Waterfall Gardens 08-05
-
268822
Singapore
| Phone | None provided |
|---|---|
| micael@gloobe.se |
Study information
| Study design | Non-randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Pharmaceutical testing facility |
| Study type | Prevention, Efficacy |
| Participant information sheet | 44299_PIS_v1.2_26Jan2021.pdf |
| Scientific title | Effect of beta glycan-containing biscuits on the Oral Glucose Tolerance Test |
| Study objectives | Beta glycan may change oral glucose tolerance tests by reducing peak values |
| Ethics approval(s) |
Approved 20/08/2021, Temasek Polytechnic Institutional Review Board (School of Applied Science, Temasek Polytechnic, East Wing Blck 1A, 21 Tampines Ave 1, Tampines, 529765, Singapore; +65 6780-5322; irb@tp.edu.eg), ref: IRB210702 |
| Health condition(s) or problem(s) studied | Sugar metabolism in healthy volunteers |
| Intervention | Healthy volunteers will be asked to come fasted to the clinic. Then they will be subjected to a routine oral glucose tolerance test (OGTT) using fingerprick blood sampling with and without prior ingestion of a biscuit containing oat beta-glucan. On day 0, One biscuit containing beta glycan derived from oats will given before the OGTT. A week later the same individual will be subjected to another OGTT this time without prior ingestion of the biscuit. |
| Intervention type | Supplement |
| Primary outcome measure | Capillary blood sugar measured using the oral glucose tolerance test on days 0 and 7 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2020 |
| Completion date | 01/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer, Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Females 2. Not pregnant 3. No medical condition 4. Age between 20-40 years old |
| Key exclusion criteria | Any known medical condition |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- Singapore
Study participating centre
Singapore
119074
Singapore
Sponsor information
Research organisation
21 Tampines Ave 1
Singapore
529757
Singapore
| Phone | +65678820000 |
|---|---|
| kalpana_bhaskaran@tp-edu.sg | |
| Website | https://www.tp.edu.sg/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The type of data stored is the result of oral glucose tolerance tests, age and gender. Data files can only be requested by contacting our public contact Micael Györei, micael@gloobe.se. The timing for availability is from December 12, 2023. Participant consent is required and was obtained Anonymised data will be stored. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 26/01/2021 | 06/11/2023 | No | Yes |
Additional files
Editorial Notes
06/11/2023: Study's existence confirmed by the Temasek Polytechnic Institutional Review Board (Singapore).
