| CTRI Number |
CTRI/2016/12/007564 [Registered on: 13/12/2016] Trial Registered Prospectively |
| Last Modified On: |
12/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Pilot study to optimize the level of protein in products for Indian primary school children |
|
Scientific Title of Study
|
Pilot study to optimize the level of protein in products for Indian primary school children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maria Pauline |
| Designation |
Associate Professor |
| Affiliation |
St. Johns National Academy of health sciences |
| Address |
Dept. of Physiology
St. John’s Medical College,
Bangalore, Karnataka , India
Bangalore KARNATAKA 560034 India |
| Phone |
9844269436 |
| Fax |
|
| Email |
mariapaulinejoe@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Maria Pauline |
| Designation |
Associate Professor |
| Affiliation |
St. Johns National Academy of health sciences |
| Address |
Dept. of Physiology
St. John’s Medical College,
Bangalore, Karnataka , India
Bangalore KARNATAKA 560034 India |
| Phone |
9844269436 |
| Fax |
|
| Email |
mariapaulinejoe@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Maria Pauline |
| Designation |
Associate Professor |
| Affiliation |
St. Johns National Academy of health sciences |
| Address |
Dept. of Physiology
St. John’s Medical College,
Bangalore, Karnataka , India
Bangalore KARNATAKA 560034 India |
| Phone |
9844269436 |
| Fax |
|
| Email |
mariapaulinejoe@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamsetji Tata Trust |
| Address |
Bombay House,24 Homi Mody Street Mumbai 400001 |
| Type of Sponsor |
Other [Trust] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maria Pauline |
St. Johns Research Institute |
Division of Nutrition, St Johns Research Institute, St. John’s National Academy of Health Sciences, Bangalore-560034
Bangalore
KARNATAKA Bangalore KARNATAKA |
9844269436
mariapaulinejoe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Indian children of both genders in the age group 6 to 10 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A legume based micronutrient-supplemented product containing 06g Protein |
Same legume base Micronutrient-supplemented product fortified with 06g protein 2 times per day (Mid morning and post lunch)for 30 days. |
| Intervention |
A legume based micronutrient-supplemented product containing 08g Protein |
Same legume base Micronutrient-supplemented product fortified with 08g protein 2 times per day (Mid morning and post lunch)for 30 days. |
| Intervention |
A legume based micronutrient-supplemented product containing 10g Protein |
Same legume base Micronutrient-supplemented product fortified with 10g protein 2 times per day (Mid morning and post lunch)for 30 days. |
| Intervention |
A legume based micronutrient-supplemented product containing 12g Protein |
A legume base Micronutrient-supplemented product fortified with 12g protein 2 times per day (Mid morning and post lunch)for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Parents willing to give an informed consent and subjects willing to give assent.
2.Boys and girls aged between 6-10 years.
3.Children with Z-scores of less than -2.0.
4.Mildly anemic (Hb<12 g/dL).
|
|
| ExclusionCriteria |
| Details |
1.Recent history (3 months) of serious infections, injuries and/ or surgeries.
2.Use of any prescription medications.
3.Children consuming nutritional supplements and/ or health food drinks on a regular basis.
4.Food allergies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference
2.Intestinal microbiota stool sample
3.Serum, urine metabolomics |
Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Micronutrient status: Hb, Serum folate, B12, ferritin, plasma iron, plasma zinc, renal and liver function test |
Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration. |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"NONE YET" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Under
nutrition is responsible for ~35% of deaths in children under 5 years of age1. Long term
childhood malnutrition is associated with reduced height achieved in adulthood
as well as increased risk of chronic disease2. This study
aims to develop affordable and sustainable sources of food products and
supplements that will improve growth parameters of children from diverse
socioeconomic backgrounds.
Though
intense efforts are going on to develop affordable healthy foods to improve
nutritional status of growing children, high inter-individual variations in
genetic background, access to health care, living conditions, amongst others
can make the use of longer-term outcomes such as growth parameters challenging3,4. Changes in the
profile of metabolic intermediates and other signaling molecules can provide an
earlier read-out of the effects of nutritional interventions in such a setting.
Though a few previous studies have examined protein and lipid kinetics in
malnourished children, till date only Bartz et al have systematically analyzed
this through the effect of in-patient milk-based formulations and out-patient
supplementation with ready-to-use therapeutic food (RUTF) on children with
severe acute malnutrition (SAM) by targeted and non-targeted metabolomic
analysis.
As
there is a dearth of studies assessing early and accurate markers of the effect
of nutritional formulations on growing children, we propose to rapidly assess
the systemic effects of novel food products on the growth of stunted but
otherwise healthy primary school children through changes in the metabolome and
the microbiome. Such markers can then be utilized in the future for testing
efficacy of a variety of nutritional formulations for selecting the most
effective, affordable and sustainable ones.
|