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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047556
Receipt No. 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

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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 -
Email 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
Email khadijachekima@gmail.com

Sponsor
Institute Taylor's University, Malaysia
Institute
Department

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 -
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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