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

06 Feb 2020

The date of last modification

Jul 01, 2020



Application Summary


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


Trial Details


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Sri Lanka College Of Paediatricians





Secondary study sponsor (If any)

None





Trial Completion details


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