UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057977 |
|---|---|
| Receipt number | R000066277 |
| Scientific Title | Effect of Low-GI Sweetened Condensed Milk on Blood Glucose Control in Healthy Adults |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/05/27 00:30:22 |
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Basic information
Public title
Managing Diabetes Risk in Adults through Informed Choices and Nutritional Knowledge
Acronym
MyDRINK
Scientific Title
Effect of Low-GI Sweetened Condensed Milk on Blood Glucose Control in Healthy Adults
Scientific Title:Acronym
MyDRINK
Region
| Asia(except Japan) |
Condition
Condition
Target disease is Type 2 Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the effect of the low glycaemic index and commercial sweetened condensed milk on blood glucose levels among Malaysian adults. Additionally, the study evaluates the pre- and post-intervention knowledge, attitude and practice (KAP) score related to diabetes prevention among Malaysian adults.
Basic objectives2
Others
Basic objectives -Others
To determine the effect of the low glycaemic index and commercial sweetened condensed milk on blood glucose levels and the pre- and post-intervention knowledge, attitude and practice score related to diabetes prevention among Malaysian adults.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The first expected outcome is that postprandial blood glucose levels (PPBG) will be significantly lower at all time intervals (30, 60, 90, and 120 minutes) following the consumption of low glycaemic index (GI) sweetened condensed milk (SCM) compared to commercial SCM. Additionally, it is predicted that the area under the curve (AUC) for PPBG will be lower with low GI SCM consumption.
Key secondary outcomes
The second expected outcome is that subjects' KAP towards diabetes prevention will significantly improve after the intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Name: Low glycaemic index sweetened condensed milk
Type: Food
Dose: 43.2g of sweetened condensed milk diluted with 173ml of water
Duration: Single dose
Description: Participants will consume a low-glycaemic index sweetened condensed milk to evaluate its effects on postprandial blood glucose levels.
Name: Nutrition Education towards Diabetes Mellitus Prevention through Knowledge, Attitude, and Practice (KAP)
Type: Other
Description: All participants will undergo a structured diabetes prevention education module focused on improving KAP toward diabetes. Pre- and post-intervention KAP questionnaires will be used to evaluate the effectiveness of the educational component.
Interventions/Control_2
Name: Commercial sweetened condensed milk
Type: Food
Dose: 42.7g of sweetened condensed milk diluted with 171ml of water.
Duration: Single dose
Description: Participants will consume a commercial sweetened condensed milk to evaluate its effects on postprandial blood glucose levels.
Name: Nutrition Education towards Diabetes Mellitus Prevention through Knowledge, Attitude, and Practice (KAP)
Type: Other
Description: All participants will undergo a structured diabetes prevention education module focused on improving KAP toward diabetes. Pre- and post-intervention KAP questionnaires will be used to evaluate the effectiveness of the educational component.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Malaysian adults
- 30-45 years old
- Non-smokers
Key exclusion criteria
- On diabetes medication and insulin treatment
- Diagnosed with chronic disease
- Dairy allergy or intolerance
- With physical or mental disabilities
- Women who are pregnant or lactating
- Medical and health sciences professions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tan |
| Middle name | Choon |
| Last name | Hui |
Organization
UCSI University
Division name
Department of Food Science and Nutrition
Zip code
56000
Address
No. 1, Jalan Menara Gading, UCSI Heights (Taman Connaught), Cheras 56000 Kuala Lumpur.
TEL
60391018880
tanch@ucsiuniversity.edu.my
Public contact
Name of contact person
| 1st name | Tan |
| Middle name | Choon |
| Last name | Hui |
Organization
UCSI University
Division name
Department of Food Science and Nutrition
Zip code
56000
Address
No. 1, Jalan Menara Gading, UCSI Heights (Taman Connaught), Cheras 56000 Kuala Lumpur.
TEL
60391018880
Homepage URL
tanch@ucsiuniversity.edu.my
Sponsor or person
Institute
Fraser & Neave Holdings Bhd (F&NHB).
Institute
Department
Personal name
Funding Source
Organization
Fraser & Neave Holdings Bhd (F&NHB).
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
UCSI Institutional Ethics Committee (IEC)
Address
No. 1, Jalan Menara Gading, UCSI Heights (Taman Connaught), Cheras 56000 Kuala Lumpur.
Tel
60391018880
ucsi.iec@ucsiuniversity.edu.my
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066277
