| CTRI Number |
CTRI/2020/04/024512 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
04/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Analytical |
| Study Design |
Other |
|
Public Title of Study
|
To compare availability of milk to the body between adults with and without gut infection |
|
Scientific Title of Study
|
Comparison of goat milk protein digestibility in adults with and without environmental enteric dysfunction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirupama Shivakumar |
| Designation |
Post graduate |
| Affiliation |
St. Johns National Academy of Health Sciences |
| Address |
Department of Physiology,
St. John’s Medical College,
Sarjapur Road, Koramangla,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
nirupama.s@sjri.res.in |
|
Details of Contact Person Scientific Query
|
| Name |
Nirupama Shivakumar |
| Designation |
Post graduate |
| Affiliation |
st. Johns National Academy of Health Sciences |
| Address |
Department of Physiology,
St. John’s Medical College,
Sarjapur Road, Koramangla,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
nirupama.s@sjri.res.in |
|
Details of Contact Person Public Query
|
| Name |
Nirupama Shivakumar |
| Designation |
Post graduate |
| Affiliation |
St. Johns National Academy of Health Sciences . Johns National Academy of Health Sciences |
| Address |
Department of Physiology,
St. John’s Medical College,
Sarjapur Road, Koramangla,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
nirupama.s@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| DBT India Alliance/ The Wellcome Trust
Plot no. 19, #8-2-684/3/K/19, 1st floor, Kaushik Society, road number 12, Banjara Hills, Hyderabad - 500034, T.S., India |
|
|
Primary Sponsor
|
| Name |
Wellcome Trust DBT India Alliance |
| Address |
DBT India Alliance/ The Wellcome Trust
Plot no. 19, #8-2-684/3/K/19, 1st floor, Kaushik Society, road number 12, Banjara Hills, Hyderabad - 500034, T.S., India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Nirupama Shivakumar |
St. Johns Medical College and Research Institute |
Department of Physiology,
Division of Nutrition,
3rd floor, Clinical Research Centre,
Robert Koch Bhavan,
Sarjapur Road
Bangalore 560034 Bangalore KARNATAKA |
9900070008
nirupama.s@sjri.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Johns Medical College and Hospital Institutional Ethical Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy adult volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Normal BMI between18.5 to 25 kg/m²; or either normal or low BMI (<18 kg/m2) for the group with EED |
|
| ExclusionCriteria |
| Details |
1. History of smoking or taking other leisure drugs
2. Consumption of alcohol in the previous 24 hours
3. History of antibiotic usage 4 weeks prior to the study
4. On iron supplementation therapy (3 months)
5. On medication such as NSAID’s, proton pump inhibitors or H2 blockers 2 days prior to and on the study day
6. Participation in any nutritional study in the last 6 months
7. History of food allergy, specifically to milk
8. Diagnosed with chronic medical or surgical illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main aim of this study is to compare the protein digestion and amino acid absorption in adults with and without EED. |
Digestibility calculation will be performed from 4 time points starting from the 5th hour to 8th hour and will be compared between the adult EED and without EED group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare true ileal indispensable amino acid digestibility of goat milk and allo-isoleucine absorption between adults with and without EED
To compare the digestibility and absorption indices obtained for adults with and without EED to plasma/fecal intestinal inflammatory biomarkers and fecal elastase-1
|
For the absorption study 4 time points of plasma enrichment of alloisoleucine will be used to calculate the absorption index
For the inflammatory biomarkers and fecal elastase-1, 1 time point stool sample will be taken and compared between the groups |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
15/04/2020 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Undernutrition persists as a major public health issue
that affects 462 million people world-wide with 165 million children being
stunted and 52 million wasted. Both acute (wasting) and chronic
malnutrition (stunting) are associated with significant health and economic
burdens in low and middle-income countries (LMICs). With consistent failure or
low effect sizes observed in nutrient supplementation interventions to
alleviate under nutritional status, the impact of a poor environment on growth
gained importance. A condition termed environmental enteric
dysfunction (EED) was identified, akin to tropical enteropathy, with features
of gut dysfunction such as villous atrophy, disruption of the normal gut
microbiota, altered gut barrier function, increased local and systemic
inflammation, and bacterial translocation, leading to increased intestinal
permeability. As a consequence of the gut abnormality noted, there
is potential for reduced nutrient digestion and absorption that could lead to
low availability of nutrients to meet the body’s demands, which in turn
influences the functionality of the individual. However, there are no studies in
humans demonstrating this reduced digestive and absorptive capacity for nutrients
particularly in an EED context. There is a lack of consensus on reliable
diagnostic tests available for EED, in spite of multiple biomarkers that have
been proposed and studied that relate to the various domains of EED.
The dual sugar absorption test (lactulose with mannitol or rhamnose) is widely
accepted for the assessment of intestinal permeability, albeit its associated limitations.
Therefore, this study aims to first, identify adults with EED using the dual
sugar absorption test, second, to determine the absorptive and digestive
capacity of amino acids in these individuals. The absorptive capacity will be
assessed by adopting an inert stable amino acid isotope (allo-isoleucine), and
the digestion will be measured using the recently development dual stable
isotope tracer technique. The intrinsically 2H labeled
goat milk will be used in the digestion protocol. In addition to this, other
intestinal inflammatory markers in the plasma and feces (plasma kynurenine
tryptophan ratio [KTR] and fecal neopterin, myeloperoxidase [MPO], alpha-1
antitrypsin [AAT]) and pancreatic exocrine function (13C-Mixed
triglyceride [MTG], Fecal Elastase-1[FE-1]) will be assessed and
correlated with digestion/absorption in the same set of adults, in order to
advance understanding of the interlinked mechanistic pathways proposed in EED. The study is proposed in adults rather than children, as it is invasive in nature where the labeled amino acid will be intravenously infused. |