Home » Trials » SLCTR/2020/007
Comparison of glucose and metabolic hormone response in obese children, following 3 rice based meals containing 3 types of resistant starch.
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SLCTR Registration Number
SLCTR/2020/007
Date of Registration
The date of last modification
Sep 09, 2020
Scientific Title of Trial
Comparison of glucose and metabolic hormone response in obese children, following 3 rice based meals containing 3 types of resistant starch.
Public Title of Trial
To assess the glucose and metabolic hormones response in obese children, following 3 rice based meals containing 3 types of resistant starch, in view of reducing obesity in children
Disease or Health Condition(s) Studied
Obesity in children
Scientific Acronym
None
Public Acronym
None
Brief title
Comparison of glucose and metabolic hormone response in obese children, following 3 rice based meals containing 3 types of resistant starch
Universal Trial Number
U1111-1241-5901
Any other number(s) assigned to the trial and issuing authority
10-2019: FMS, USJ
What is the research question being addressed?
Is there a change in the glucose and metabolic hormones response to resistant starch type 5 (rice +coconut oil) in obese children in comparison to resistant starch 4, and resistant starch 5 and protein?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Basic science
Study Phase
Not Applicable
Intervention(s) planned
Study setting
The study will be conducted among obese children who attend the Endocrine and diabetic unit Lady Ridgeway Hospital for Children.
The first 20 children who visit the above study setting, fulfill the inclusion criteria and consent to participate will be included.
Rice test meal
Following test meals will be prepared,
Test meal 1: Cooked Suduru samba
Test meal 2: Suduru samba cooked with coconut oil (100g rice cooked with 3g coconut oil)
Test meal 3: Suduru samba cooked with coconut oil (100g rice cooked with 3g of coconut oil) served with 20 g of cooked red lentil The selected children will be given three different test meals, at different clinic visits one week apart. Each rice test meal will be consumed with one tablespoon (10 grams) of onion sambol (100 grams of onion sambol which will be prepared with adding half a teaspoon of salt and one teaspoon of chili powder) within 15minutes followed by 180 ml of water.
Principle investigator will prepare the rice meals at home with appropriate hygienic measure.
Inclusion criteria
• Both male and female children
• Age between 10-12 years
• BMI centile over 95% [BMI between +2SD and +3SD in WHO chart]
• Obese children with normal glucose metabolism (HbA1C <5.7%) and without other comorbidities such as hypertension (blood pressure less than 95th centile for height, sex and age), hyperlipidemia Children with normal ultra sound liver and stage I fatty liver (mild fatty liver)
Exclusion criteria
Children with chronic diseases such as, hypertension, hyperlipidemia, pre-diabetes/diabetes mellites, fatty liver grade >2
BMI > 3SD in WHO chart
Children with renal, liver, lung, and neurological disorders
Children on corticosteroids
Primary outcome(s)
|
1.
To assess and compare the plasma glucose response using fasting and postprandial blood sugars tests |
[ 60, 120, 180 minutes after each test meals ] |
|
2.
To assess and compare the post prandial plasma insulin, leptin and ghrelin after ingestion of the following test meals using ELISA method |
[ 120 minutes after each test meal ] |
|
3.
To assess and compare plasma leptin, PYY and GLP 1 response using ELISA method |
[ 180 minutes after each test meal ] |
|
4.
Satiety and hunger using an in-house visual analog scale analog scale to measure the subjective response |
[ 15, 60,120 and 180 min [after each test meal?] ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
20
Countries of recruitment
Sri Lanka
Anticipated start date
2020-02-06
Anticipated end date
2020-08-01
Date of first enrollment
2020-02-10
Date of study completion
Recruitment status
Recruiting
Funding source
Sri Lanka College of Paediatricians
Regulatory approvals
Status
Approved
Date of Approval
2019-09-26
Approval number
10/2019
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Sri Lanka |
| Telephone: | 94-11-2758588, Fax 94-11-2811480, |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Jananie Suntharesan
Senior registrar paediatric endocrinologist
Endocrine and diabetic clinic
Lady Ridgeway Hospital for Children
0112693711
0772508731
0112686859
jananiesuntharesan@gmail.com
Contact Person for Public Queries
Dr. Navoda Atapattu
Consultant Paediatric Endocrinologist
Endocrine and Diabetes Unit, Lady Ridgeway Hospital for Children, Colombo 8.
0112683712 Ext 460 or ( call to room No 36)
0772995039
0112686859
navodaa@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
