CTRI Number |
CTRI/2021/06/034006 [Registered on: 04/06/2021] Trial Registered Prospectively |
Last Modified On: |
03/06/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Protein Absorption in Adults |
Scientific Title of Study
|
Assessment of peptide and amino acid absorption in adults |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
There is no secondary ID |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Anura V Kurpad |
Designation |
Professor |
Affiliation |
St John’s Medical College |
Address |
St. Johns National Academy of Health Sciences, Sarjapura Road 3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences Bangalore KARNATAKA 560034 India |
Phone |
9686512233 |
Fax |
|
Email |
a.kurpad@sjri.res.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nirupama Shivakumar |
Designation |
Clinical Research Fellow |
Affiliation |
St. Johns Research Institute |
Address |
St. Johns National Academy of Health Sciences, Sarjapura Road 3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences Bangalore KARNATAKA 560034 India |
Phone |
9900070008 |
Fax |
|
Email |
nirupama.s@sjri.res.in |
|
Details of Contact Person Public Query
|
Name |
Dr Nirupama Shivakumar |
Designation |
Clinical Research Fellow |
Affiliation |
St. Johns Research Institute |
Address |
St. Johns National Academy of Health Sciences, Sarjapura Road 3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences Bangalore KARNATAKA 560034 India |
Phone |
9900070008 |
Fax |
|
Email |
nirupama.s@sjri.res.in |
|
Source of Monetary or Material Support
|
Queen Mary University of London Global Challenge Research Fund |
|
Primary Sponsor
|
Name |
Queen Mary University of London Global Challenge Research Fund |
Address |
Mile End Road, London E1 4NS |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
Zambia India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Nirupama Shivakumar |
St. Johns Research Institute |
3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences Bangalore KARNATAKA |
9900070008
nirupama.s@sjri.res.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institution Ethics Committee St. Johns Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Adult healthy volunteers, mainly staff of St. John’s Medical College and Research Institute, and their known contacts, in the age range of 18 to 35 years |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Both |
Details |
Normal BMI between18.5 to 25 Kg/m² |
|
ExclusionCriteria |
Details |
History of smoking or taking other leisure drugs
· Consumption of alcohol in the previous 24 hours
· History of antibiotic usage 4 weeks prior to the study
· On iron supplementation therapy (3 months)
· On medication such as NSAID’s, proton pump inhibitors or H2 blockers 2 days prior to and on the study day
· Participation in any nutritional study in the last 6 months
· History of food allergy, specifically to milk
· 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 |
To determine associations between uptake of C6, 15N allo-isoleucine or uptake of dipeptide Gly-Sar with lactulose-rhamnose ratio and pro inflammatory markers in stool and plasma. |
Outcome will be assessed only on the experiment day, so only one time point. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
Not applicable |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="6"
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)
|
15/06/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
15/06/2021 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
No publications |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Environmental Enteropathy (EE) is a global disorder which contributes to poor child growth, micronutrient deficiencies, and impaired responses to oral vaccines. There is evidence that EE is associated with malabsorption of zinc, but the effects on other intestinal functions are unknown. The principal function of the intestine is to digest and absorb nutrients from the luminal stream, and several biochemical processes are essential to this dominant function. These processes include digestion of proteins into amino acids and dipeptides, digestion of complex carbohydrates into monosaccharides, emulsification and digestion of lipids. Nutrients, including these macronutrients together with micronutrients such as elements and vitamins, are absorbed by epithelial cells using a very complex array of several hundred transporters. A considerable amount of research was carried out on nutrient digestion and absorption in the 1960s and 1970s, but much less has been done recently. Recent elucidation of the importance of EE in global health and nutrition has highlighted the lack of information on digestion and absorption in the world literature, and there is almost no information on the impairments of digestion and absorption related to EE in adults and children in low and middle income countries. A clinical study of the 13C sucrose breath test (13C-SBT) and the 13C mixed chain triglyceride test (13C-MCTT), was conducted by Paul Kelly and colleagues (collaborating team). The results of the SBT show useful correlation between 13CO2 in breath and three measures of intestinal dysfunction: villus height and surface area, mucosal sucrose-isomaltase expression by immunostaining, and sucrose activity measured ex vivo in biopsies. However, this test only measures mucosal disaccharidase activity. We now want to go on and find tests for other aspects of mucosal digestive/absorptive function. The significance of this study is that impairments of digestive and absorptive function can be overcome, by using enzymatic supplements, by using specially modified feeds, and/or by providing additional specific nutrients to overcome absorptive defects. While we are developing these tests in adults, the longer term objective is to adapt them for use in children with growth faltering, and to define nutritional modifications which these children may need. |