UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047556 |
|---|---|
| Receipt number | R000054232 |
| Scientific Title | Use of rtCGM as part of a low glycaemic index and load diets and its effects on overweight and obese young adults |
| Date of disclosure of the study information | 2022/04/22 |
| Last modified on | 2022/04/22 12:45:37 |
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Basic information
Public title
Use of rtCGM as part of a low glycaemic index and load diets and its effects on overweight and obese young adults
Acronym
Use of rtCGM as part of a low glycaemic index and load diets and its effects on overweight and obese young adults
Scientific Title
Use of rtCGM as part of a low glycaemic index and load diets and its effects on overweight and obese young adults
Scientific Title:Acronym
Use of rtCGM as part of a low glycaemic index and load diets and its effects on overweight and obese young adults
Region
| Asia(except Japan) |
Condition
Condition
overweight and obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the integration of rtCGM feedback with low GI and GL nutrition recommendations into behaviour modification intervention to improve dietary habits and body composition
Basic objectives2
Others
Basic objectives -Others
To evaluate the integration of rtCGM feedback with low GI and GL nutrition recommendations into behaviour modification intervention to improve dietary habits and body composition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight (baseline and 8 weeks)
Key secondary outcomes
Anthropometric measurement (body mass, BMI),body composition (fat mass, visceral fat rating, lean body mass, biocohemica test (fasting plasma insulin, HbA1c, fasting glucose, lipid profile) rtCGM data, food diary (measured at baseline and at 8 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Behavior,custom |
Interventions/Control_1
Intervention group (using rtCGM)
Interventions/Control_2
Control group (not using rtCGM)
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Overweight or obese individuals
2. 18 to 35 years old
3. Non-smoking (de-fined as less than or 1 cigarette/day)
4. Consuming alcoholic drink of less than or 14 alcoholic drinks/week (1 drink is equivalent to 10 g alcohol)
5. Stable body weight (plus minus 3 kg) for the past 3 months
6. Normal fasting blood glucose (less than 5.6 mmol/L).
Key exclusion criteria
1. Pregnant or lactating women
2. Following a vigorous weight loss regimen
3. Diabetic
4. Suffering from hepatic or renal dysfunction
5. Taking medication or supplementation that affects appetite or food intake
6. Using medication that may affect glucose metabolism (eg. corticoids, thyroid hormones, and thiazide diuretics)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | khadidja |
| Middle name | |
| Last name | chekima |
Organization
Taylor's University
Division name
Faculty of Medicine and Health Sciences
Zip code
47500
Address
1, Jalan Taylors, Subang Jaya,
TEL
-
khadijachekima@gmail.com
Public contact
Name of contact person
| 1st name | khadidja |
| Middle name | |
| Last name | chekima |
Organization
Taylor's University
Division name
Faculty of Medicine and Health Sciences
Zip code
47500
Address
1, Jalan Taylors, Subang Jaya,
TEL
-
Homepage URL
khadijachekima@gmail.com
Sponsor or person
Institute
Taylor's University, Malaysia
Institute
Department
Personal name
Funding Source
Organization
Taylor's University, Malaysia
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malaysian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Taylor's University
Address
1, Jalan Taylors, Subang Jaya,
Tel
-
khadijachekima@gmail.com
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
Taylor's University (Malaysia)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 22 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054232
