| CTRI Number |
CTRI/2023/10/059332 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Millets Supplementation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to explore the efficacy of millets in athletic population |
|
Scientific Title of Study
|
A COMPREHENSIVE STUDY TO ESTABLISH THE HEALTH BENEFITS (IN-VIVO)OF NUTRI-CEREALS" A WAY FORWARD FOR MAINSTREAMING MILLETS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kommi Kalpana |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Dept of Nutrition and Dietetics
School of Allied Health Sciences
Manav Rachna International Institute of Research and Studies,
Faridabad, India
Faridabad
HARYANA
121004
India |
| Phone |
9701408969 |
| Fax |
|
| Email |
kommikalpana80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kommi Kalpana |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Dept of Nutrition and Dietetics
School of Allied Health Sciences
Manav Rachna International Institute of Research and Studies,
Faridabad, India
Faridabad
HARYANA
121004
India |
| Phone |
9701408969 |
| Fax |
|
| Email |
kommikalpana80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kommi Kalpana |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Dept of Nutrition and Dietetics
School of Allied Health Sciences
Manav Rachna International Institute of Research and Studies,
Faridabad, India
Faridabad
HARYANA
121004
India |
| Phone |
9701408969 |
| Fax |
|
| Email |
kommikalpana80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Agriculture and Farmers Welfare, Department of Agriculture and Farmers Welfare, Division of Crops and Post Harvest Management of Food Grain, NFSM, Krishi Bhawan, New Delhi |
|
|
Primary Sponsor
|
| Name |
Ministry of Agriculture and Farmers Welfare |
| Address |
Ministry of Agriculture and Farmers Welfare, Department of Agriculture and Farmers Welfare, Division of Crops and Post Harvest Management of Food Grain, NFSM, Krishi Bhawan, New Delhi |
| 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 |
| DrKommi Kalpana |
Manav Rachna International Institute of Research and Studies |
Department of Nutrition and Dietetics, School of Allied Health Sciences, Q Block, Room No. QT11/4,Manav Rachna International Institute of Research and Studies, Surajkund, Sector-43, Faridabad
Faridabad
HARYANA |
9701408969
kommikalpana80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee, MRIIRS, FARIDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Free from illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finger Millet supplementation
Pearl Millet supplementation |
Finger millet or pearl millet products (1/3rd of the daily cereals will be given for 60 days |
| Comparator Agent |
Rice/ wheat based diet |
The control group will follow the regular Rice/ wheat based diet for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
The inclusion criteria will be competitive athletes in the age between 18-25yrs, general good health and a willingness to either follow the trial guidelines (eg, avoid potentially conflicting nutritional or vitamin supplements) or provide notification of compliance. |
|
| ExclusionCriteria |
| Details |
Consumption of millets, alcohol, smokers, any recent history of acute or chronic debilitating illness, medication, consumption of dietary supplements and ergogenic aids, physical disabilities, presence of sports injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of finger millet supplementation on appetite hormones would be known.
Information on the effect of pearl millet in context to serum micronutrient status, gut health and immune-modulating factors in athletes would be known.
The effect of pearl millet on physiological would be known.
|
Baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of pearl millet and finger millet on cognitive performance would be known. |
Baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2023 |
| Date of Study Completion (India) |
15/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kommikalpana80@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Millets are rich source of slow digesting carbohydrates, minerals, dietary fibre, essential fatty acids and B-complex vitamins and minerals. Millets have numerous health benefits due to their nutritional composition. Apart from its nutraceutical properties, studies have highlighted its role in gut health and in immune response modulation. However, the nutritional and health benefits of millets have not been explored in athletic population. Hence, the preliminary exploratory study will attempt to examine effect of millets on appetite hormones, micronutrient status, gut health, immunomodulation, physiological and cognitive performance in athletes. A randomised controlled trial will be conducted to compare the efficacy of Finger millet on appetite hormones and cognitive performance in athletes (Study-I; n=60) and efficacy of pearl millet on micronutrient status, gut health, immunomodulation, physiological and cognitive performance in athletes (Study -II; n=60). Baseline information such as socio-demographic profile, anthropometry, 3 days dietary intake and activity recording will be done. Biochemical and performance tests will be conducted. Information on cognitive performance will be collected. Based on the baseline information, the athletes will be randomly assigned to the experimental group (n=30) and to the control group (n=30). Finger millet or pearl millet products (1/3rd of the daily cereals will be given to experimental group and rice /wheat-based diet to the control group. athletes for 60 days. End line information will be collected following the similar procedures of baseline on anthropometry, nutrient intake, biochemical tests, cognitive and physical performance. |