| CTRI Number |
CTRI/2023/12/060650 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Determine the efficacy of two Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy, adults |
|
Scientific Title of Study
|
A Prospective, Single Blind, Randomized, Placebo Controlled, Crossover, Study to Determine the efficacy of two Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy, adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NUN-HFD-006/23 Protocol v1.0 26th October 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Mishra |
| Designation |
Principal Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited 136, Sector 5, IMT Manesar, Gurugram- 122050, Haryana, India
Gurgaon
HARYANA
122050
India |
| Phone |
8527569065 |
| Fax |
|
| Email |
medreview@aurigaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Karwa |
| Designation |
Head Clinical Trials and Pharmacovigilance |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited 136, Sector 5, IMT Manesar, Gurugram- 122050, Haryana, India
Gurgaon
HARYANA
122050
India |
| Phone |
9313367656 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Khanna |
| Designation |
Clinical Research and Claims Capability Leader, HFD |
| Affiliation |
Hindustan Unilever Limited |
| Address |
Hindustan Unilever Limited
Nutrition Research and Development Centre
Plot Number 67, Sector 32, Gurgaon 122001, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
911244097100 |
| Fax |
|
| Email |
deepti.khanna2@unilever.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited
Unilever House,
B D Sawant Marg Chakala,
Andheri East Mumbai 400099,
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Deepti Khanna |
| Address |
Hindustan Unilever Limited
Nutrition Research and Development Centre
Plot Number 67, Sector 32, Gurgaon -122001, Haryana, India |
| Type of Sponsor |
Other [Sponsor representative details added] |
|
|
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 Sanjay Mishra |
Auriga Research Private Limited |
Auriga Research Private Limited 136, Sector 5, IMT Manesar,
Gurugram- 122050, Haryana, India
Gurgaon
HARYANA |
8527569065
medreview@aurigaresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To study the effect of a protein supplement in milk on plasma levels of amino acid profile in healthy Indians adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Horlicks Protein Plus and Horlicks Strength Plus |
Product A (30 g of Horlicks Protein Plus) will be administered with 200 ml low fat milk
Product B (30 g of Horlicks Strength Plus) will be administered with 200 ml low fat milk.
Visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product
|
| Comparator Agent |
Maltodextrin |
Product C (Placebo i.e., 30 g maltodextrin) will be administered with 200 ml low fat milk.
Visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling all inclusion criteria below will be considered for the study.
1. Healthy adult male or female participants aged greater than or equal to 25 and less than or equal to 60 years, will be considered.
2. Participants having a Body Mass Index (BMI) in the range 20.0 to 30.0 kg/m2 (both inclusive) and weight of at least 50 kg will be considered.
3. Participant with normoglycemia which means fasting plasma glucose (FPG) less than 100mg/dl (as per ADA guidelines) will be considered.
4. Women in the reproductive age group if non-lactating and having negative test for pregnancy will be considered for the study,
5. Participant should not have taken part in a clinical trial in the last 3 months.
6. Participant should be able to read and understand and ready to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Participants having resting hypotension i.e., BP less than 90 and 60 or hypertension BP more than 139 and 89 will be excluded.
2.Participants having pulse rate below 50 per min. and above 99 per min will be excluded.
3.Participants with known medical history of any of the conditions listed below, will be excluded.
A. food allergy including lactose intolerance.
B. drug abuse or alcoholism i.e., alcohol consumption more than 2 units per day or 10 units per week one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer.
C. smoking or tobacco consumption.
D. diabetes and hyperglycaemia.
E. intake or administered protein supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs in the last 14 days prior to the study.
F. illness or has been hospitalized in the last 4 weeks preceding the start of the study.
G. gastrointestinal, liver or kidney disease, or presence active peptic ulceration or a history of peptic ulceration or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
4.Potential participants who are related e.g., husband and wife or brother and sister or persons living in the same household e.g., tenants sharing a household cannot be recruited together in the study one of participants will be excluded.
5.Participants following any protein-rich dietary regime, muscle toning or body building program and not willing to discontinue such regime or program during the conduct of study will be excluded.
6.Any potential participant who is an employee of Sponsor, or the site CRO conducting the study will be excluded. The participants must also not be related to any personnel conducting the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy adults |
There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the level of each TSAA, post supplementation between the arms will be considered for significance i.e., change between the arms Arm1 with Placebo & Arm 2 with Placebo. |
There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2023 |
| Date of Study Completion (India) |
23/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study aims to study the effect of protein supplement in milk on plasma levels of amino acid profile in healthy adults greater than or equal to 25 to less than or equal to. 60 years of age. The main objective of this study is to investigate the effect of protein-based, oral nutritional supplement (P-ONS) given in milk on the plasma levels of essential amino acids (EAAs) in healthy Indian adults, using targeted essential amino acid (EAA) analysis |