| 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
|
|
|
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
|
|
|
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 “7 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.
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