| CTRI Number |
CTRI/2026/03/105801 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of nutritious plant-based millet milk alternatives and evaluation of their nutritional benefits among consumers. |
|
Scientific Title of Study
|
Formulation and Evaluation of Nutrient rich plant based milk alternatives and derived products |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A YASMIN FATHIMAA |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Nutrition and Dietetics
Meenakshi Academy of Higher Education and Research
Faculty of Allied Health Sciences
Meenakshi University Campus
KK Nagar Chennai 600078
Tamil Nadu India
Department of Nutrition and dietitcs
Meenakshi Academy of Higher Education and Research
Faculty of Allied Health Sciences
12 Vembuliamman Koil St Annaji Nagar KK Nagar West Chennai Tamil Nadu 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9944866966 |
| Fax |
|
| Email |
sychennaijmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Pavithra Amritkumar |
| Designation |
Associate dean counsultancy |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Research
Meenakshi Academy of Higher Education and Research, Chennai
12 Vembuliamman Koil St Annaji Nagar KK Nagar West Chennai Tamil Nadu 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9940052696 |
| Fax |
|
| Email |
srikumaripavithra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A YASMIN FATHIMAA |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
room no 1 scholars working station
Department of Nutrition and Dietetics
Faculty of Allied Health Sciences
Meenakshi Academy of Higher Education and Research
12 vembuliamman koil
KK Nagar Chennai 600078
Tamil Nadu India
Department of Nutrition and Dietetics
Faculty of Allied Health Sciences
Meenakshi Academy of Higher Education and Research
12 Vembuliamman Koil
KK Nagar Chennai 600078
Tamil NaduIndia
Chennai
TAMIL NADU
600078
India |
| Phone |
9944866966 |
| Fax |
|
| Email |
sychennaijmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Meenakshi academy of higher education and research |
| Address |
12, Vembuliamman Koil St KK Nagar Chennai Tamil Nadu 600078 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Yasmin fathimaa |
Meenakshi academy of higher education and research |
FACULTY OF PHYSIOTHERAPY
12 Vembuliamman Koil St KK Nagar Chennai Tamil Nadu 600078
Chennai
TAMIL NADU |
9944866966
sychennaijmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cows milk |
cows milk based products |
| Intervention |
Finger Millet based Ready to Use Plant Based Beverage |
Development of three nutrient-rich plant-based beverage variants derived from finger millet (Eleusine coracana). The beverages will be processed and converted into Ready-to-Use (RTU) products using spray drying technology. The developed products will be standardized and evaluated for nutritional composition and safety through in-vitro analysis. The prepared RTU beverages will be administered to healthy adult participants for sensory evaluation and acceptability using a 9-point hedonic scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male and female volunteers aged 18–60 years.
Participants who are generally healthy with no known acute or chronic illness
Individuals willing to consume the product |
|
| ExclusionCriteria |
| Details |
Individuals below eighteen years or above sixty years of age
Individuals with serious medical conditions such as gastrointestinal disorders metabolic diseases or chronic illness that may affect food consumption.
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional composition (protein, fat, carbohydrate, mineral content) and sensory acceptability of formulated plant-based milk alternatives. |
Baseline and at the end of product formulation (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physicochemical characteristics shelf life stability of plant based milk alternatives |
Baseline at the end of the study eight weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/03/2026 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study focuses on the development and evaluation of nutrient rich plant based milk alternatives derived from finger millet Eleusine coracana. Finger millet is a highly nutritious millet that contains important nutrients such as dietary fiber protein minerals and antioxidants which are beneficial for human health.
The study aims to develop three plant based beverage variants using finger millet and to standardize the formulated products. The developed beverages will be processed into ready to use products using spray drying technology to improve shelf life and convenience.
The developed products will be evaluated for nutritional composition including moisture protein fat carbohydrate fiber and ash content. Safety and toxicity of the products will be assessed through in vitro analysis.
The acceptability of the developed ready to use beverages will be evaluated among healthy adult participants aged between 18 and 60 years. Sensory evaluation will be conducted using a nine point hedonic scale to assess attributes such as appearance color taste flavor texture and overall acceptability.
The study will help in developing a nutritious plant based beverage product from finger millet which may contribute to improving dietary diversity and promoting the utilization of millets in human nutrition. |