FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029622 [Registered on: 07/12/2020] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measurement of dietary sugar intake in adults  
Scientific Title of Study   Sugar intake in India: The estimation of dietary intake using the stable isotopic biomarker method of carbon isotope ratio 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumathi Swaminathan 
Designation  Associate Professor 
Affiliation  Associate Professor 
Address  St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax  08025501088  
Email  sumathi@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Sumathi Swaminathan 
Designation  Associate Professor 
Affiliation  Associate Professor 
Address  St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax  08025501088  
Email  sumathi@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Sumathi Swaminathan 
Designation  Associate Professor 
Affiliation  Associate Professor 
Address  St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
St Johns Research Institute St Johns National Academy of Health Sciences Sarjapur Road Koramangala
Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax  08025501088  
Email  sumathi@sjri.res.in  
 
Source of Monetary or Material Support  
International Atomic Energy Agency Vienna International Centre PO Box 100 1400 Vienna 
 
Primary Sponsor  
Name  International Atomic Energy Agency 
Address  Vienna International Centre PO Box 100 1400 Vienna Austria 
Type of Sponsor  Other [International organization under the United Nations] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sumathi Swaminathan  St Johns Research Institute  Division of Nutrition, 1oo feet road, John Nagar, Koramangala Bangalore - 5600034, Karnataka
Bangalore
KARNATAKA 
08049467000
08025501088
sumathi@sjri.res.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Weight stable over a period of 2 weeks (definition based on consensus)
2. BMI ≥ 18.5 kg/m2

 
 
ExclusionCriteria 
Details  1. Adults on any medication
2. Any morbidity or history of any of the chronic diseases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Assessment of sugar intake through diet recalls
Estimation of blood biomarkers of whole serum Carbon Isotope ratio and serum amino acid CIR 
For Outcome 1:
7 non consecutive days within one month of recruitment

For outcome 2:
End of one month after recruitment
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Estimation of energy expenditure on a subsample using doubly labelled water
2. Validation of diet intake from diet recall versus TEE from doubly labelled water 
2.5 weeks after recruitment 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="73" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
02/11/2021 
Date of Study Completion (India) 24/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Globally rapid changes have occurred in diet patterns due to the nutrition transition. These have resulted in massive shifts in diet intake including that of added sugars. Conventional subjective methods of dietary assessment although very useful, still have limitations in determining accurate intakes of sugar due to measurement errors that occur. An objective method with the use of the stable isotopic technique of determining the carbon isotope ratio (13C/12C) or CIR shows promise as a suitable biomarker of sugar intake. Generally, the plants which use the four carbon mode for photosynthesis, that is C4 plants, express a higher amount of stable isotope 13C.

In countries using cane sugar as a predominant source of added sugar, the validity and specificity of the CIR could be high provided usage of corn containing processed foods are not high. Thus, in India using the total CIR may work as meat intakes are also not as high as in the developed countries, while in other countries a better method will be to use CIR-ala which is expensive compared to estimation of total CIR. But both the methods need to be tested across several populations and developed further for use as an appropriate biomarker as up till now studies have been conducted mostly in the US.

Thus, the primary objective of this study is to assess the utility of a biomarker to assess added sugar intake in India. Additionally, sugar intake  will also be assessed based on dietary recalls. An Interviewer administered  24-hour dietary recall will be collected on  â€œ7 non consecutive days over a period of a month “which will include 2 weekend recalls to get the intake of added sugar as well as meat intake using the database and software developed at the Division of Nutrition, St John’s Research institute.  The Secondary objective is to validate the total energy intake obtained through 24-hour dietary recalls with the stable isotopic technique of doubly labelled water to test the accuracy of the recall data collected.

To test the utility of the CIR biomarker, healthy adult subjects will be recruited, their blood and breath samples will be collected to determine 13C values. If possible, a hair sample will also be taken as per a standardized protocol. On a sub-sample, the stable isotopic method of doubly labelled water (DLW) will be used to obtain total energy expenditure (TEE) and to correct for bias in energy intake obtained through the multiple 24-hour dietary recalls. BMR will also be measured. Thus, through this study we will be able to demonstrate the suitability of a biomarker for estimating added sugar intake which is more relevant in the present world with global rates of non-communicable disease increasing rapidly.


 
Close