| CTRI Number |
CTRI/2026/01/100551 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Hydration Efficacy of Isomaltulose vs. Sucrose Electrolyte Beverages in Healthy Adults and Diabetes Patients |
|
Scientific Title of Study
|
Comparative Evaluation of Hydration Efficacy (Beverage Hydration Index: BHI) of an Electrolyte Beverage Containing Isomaltulose Versus an Electrolyte Beverage Containing Sucrose in Healthy Adults and Patients with Type-2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS2024DH100209 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A G Unnikrishnan |
| Designation |
Chief Endocrinologist |
| Affiliation |
Chellaram Diabetes Institute |
| Address |
1st Floor, Lalani Quantum, Pune-Bangalore NH-4
NH-4, Bavdhan (Budruk)
Pune
MAHARASHTRA
411021
India |
| Phone |
7969379777 |
| Fax |
|
| Email |
uagcdi@cdi.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Chamle |
| Designation |
Medical Head: Baby- India, Restoration & Digestive Health- APAC |
| Affiliation |
Kenvue |
| Address |
4th Floor, Arena Space, Off JVLR, Behind Majas Depot,
Jogeshwari (East)
Mumbai
MAHARASHTRA
400060
India |
| Phone |
9167302110 |
| Fax |
|
| Email |
VChamle@kenvue.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Purusothaman |
| Designation |
Senior Scientist R&D Translational Science |
| Affiliation |
Kenvue |
| Address |
LBS Marg, West Mulund
Mumbai
MAHARASHTRA
400080
India |
| Phone |
9962695791 |
| Fax |
|
| Email |
PDivya01@kenvue.com |
|
|
Source of Monetary or Material Support
|
| Johnson & Johnson Pte Ltd,
with Offices at 2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222
|
|
|
Primary Sponsor
|
| Name |
Johnson & Johnson Pte Ltd |
| Address |
Offices at 2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 A G Unnikrishnan |
Chellaram Diabetes Institute |
1st Floor, Lalani Quantum, Pune-Bangalore Highway, Bavdhan Budruk
Pune
MAHARASHTRA |
02066839777
cdiacademy@cdi.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chellaram Diabetes Institute Ethics Committee Chellaram Diabetes Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chromium & Isomaltulose drink with added electrolytes |
1 L (divided in 5 equal parts),
Oral, Day 1 of Period 1/2/3
|
| Comparator Agent |
Chromium & Sucrose drink with added electrolytes |
1 L (divided in 5 equal parts), Oral, Day 1 of Period 1/2/3 |
| Comparator Agent |
Water |
1 L (divided in 5 equal parts), Oral, Day 1 of Period 1/2/3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Adult Population
1. Participant has signed and dated informed consent document before participating in any study-specific
procedures, indicating the participant has been informed of all pertinent aspects of the study.
2. Participant is able to read and understand the local language.
3. Adults with age range of 18 to 30 years.
4. Healthy adults with no known interfering/limiting conditions as judged by the PI based on detailed Medical
History
5. Participants with Body Mass Index: BMI 18.5–22.9 kg/m2.
6. Participants with USG less than or equal to 1.025 (at arrival of each testing period).
7. The participant should refrain from tobacco and caffeine usage for at least 12 hours, from consuming alcohol
and from participating in strenuous physical activity for at least 24 hours prior to each experimental period.
8. The participant is able to comprehend the requirements of the study (based upon clinical site personnel’s
assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and
other study procedures specified within the protocol.
Patients with T2DM
1. Participant has signed and dated informed consent document before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study.
2. Participant is able to read and understand the local language.
3. Adults with age range of 18 to 60 years.
4. Diagnosed with T2DM for more than or equal to 12 weeks; treated with metformin with or without sulfonylureas at a stable dose for more than or equal to 12 weeks.
5. Participants with Body Mass Index: BMI 18.5 – less than 35 kg/m2.
6. Participant with USG less than or equal to 1.025 (at arrival of each testing period).
7. Participant with HbA1c of 6.5percent–9percent.
8. The participant refrained from tobacco and caffeine usage for at least 12 hours, from consuming alcohol and from participating in strenuous physical activity for at least 24 hours prior to each experimental period.
9. The participant is able to comprehend the requirements of the study (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol.
10. Patients with T2DM who does not have comorbidities or who have co-existing stable conditions commonly seen in this population, as listed below:
o Fairly-controlled hypertension (e.g., BP less than 150/100 mmHg with or without medication).
o History of early-stage diabetic nephropathy (e.g., estimated glomerular filtration rate: eGFR more than 60 mL/min/1.73m²) a.
o Stable cardiovascular disease (e.g. more than 6 months post-MI, no recent angina or congestive heart failure: CHF exacerbations).
|
|
| ExclusionCriteria |
| Details |
Healthy Adult Population
1. Participants with any history of diabetes or impaired glucose tolerance.
2. Female participants who are pregnant or breastfeeding or planning to become pregnant.
3. Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months).
4. Participants with any prescribed medications at the time of inclusion that may interfere with carbohydrate metabolism and fluid balance, e.g., diuretics, cyclosporin, steroids or any other treatments that cannot be allowed in the study, in the opinion of the investigator.
5. Known sensitivity to the investigational product(s) and its ingredients.
6. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
7. Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participant participation in the study in the opinion of the medically qualified investigator.
8. Participants are following prolonged fasting or intermittent fasting (e.g., fasting periods exceeding 12-16 hours regularly).
9. Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each).
10. Participants who have other severe, acute or chronic, medical condition(s) (e.g., CVD, renal disease, UTI), laboratory abnormality(ies), or history of gastrointestinal surgery(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant
inappropriate for entry into this study.
Patients with T2DM
1. Females who are pregnant or breastfeeding, or planning to become pregnant.
2. Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months).
3. Adults on prescribed medication at the time of inclusion that may interfere with carbohydrate metabolism, (other than metformin with or without sulfonyl ureas) and fluid balance, e.g. cyclosporin, or any other treatments that cannot be allowed in the study, in the opinion of the investigator.
4. Adults on prescribed medications at the time of inclusion like Steroids, SGLT2 inhibitors, GLP-1 agonists, diuretics, alpha-glucosidase inhibitor, and drugs that affect hydration status.
5. Known sensitivity to the investigational product(s) and its ingredients.
6. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
7. Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participation of the participant in the study in the opinion of the medically qualified investigator.
8. Participants with following conditions will be excluded:
o Known to have hepatic impairment - Known cirrhosis or ALT/AST more than 3 times ULN.b
o Type-1 diabetes mellitus or latent autoimmune diabetes in adults (LADA).
o History of severe hypoglycemia or unawareness in the last 6 months.
9. Participants are following prolonged fasting or intermittent fasting (e.g., fasting periods exceeding 12-16 hours regularly).
10. Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each).
11. Participant who to have other severe, acute or chronic, medical condition(s) (eg. UTI), laboratory abnormality(ies), or history of gastrointestinal surgery(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healthy Adult Population
Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose
Patients with T2DM
Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose |
Healthy Adult Population
Post 2 hours of beverage consumption.
Patients with T2DM
Post 2 hours of beverage consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Healthy Adult Population and Patients with T2DM
a) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose
b) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the water
c) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the water
d) Difference in blood glucose levels between beverages following consumption of fluids
e) Difference in plasma insulin levels between beverages following consumption of fluids
f) Difference in plasma lactate levels between beverages following consumption of fluids
g) Difference in net fluid balance between beverages following consumption of fluids |
Healthy Adult Population and Patients with T2DM
a) Post 4 hours of beverage consumption
b) Post 2 hours of beverage consumption
c) Post 4 hours of beverage consumption
d) Baseline, and for every 30 min upto 4 hours post beverage consumption
e) Baseline, and for every 30 min upto 4 hours post beverage consumption
f) Baseline, and for every 30 min upto 4 hours post beverage consumption
g) Baseline, and for every 30 min upto 4 hours post beverage consumption |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
27/02/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Three experimental arm (period) study will be conducted in randomized, single-blind (participants), cross-over fashion for two populations; euhydrated healthy adults and patients with type-2 diabetes mellitus. The primary purpose of this study will focus on the evaluation of hydration efficacy of an electrolyte beverage containing isomaltulose and compare it to one containing sucrose in both healthy adults and patients with Type 2 Diabetes Mellitus (T2DM). Secondary purpose will include analyzing metabolic responses of isomaltulose beverage such as blood glucose, plasma insulin, and plasma lactate levels, as well as net fluid balance and to compare with that of sucrose beverage and water in both the population. |