| CTRI Number |
CTRI/2025/07/090278 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Wellness] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Protein, Prebiotic and Probiotic based Nutritional powder on Muscle Health in Adults |
|
Scientific Title of Study
|
Effectiveness of Complan VieMax High-Protein Nutritional Powder on
Muscle Strength: A Comparative Real-World Evidence study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Banshi Saboo |
| Designation |
Chief Diabetologist and Endocrinologist |
| Affiliation |
DiaCare Research |
| Address |
Department of Endocrinology, 1-2 Gandhi Park, near Nehrunagar cross road, Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
9824047676 |
| Fax |
|
| Email |
banshisaboo@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devina Aswal |
| Designation |
Senior Manager Medical Affairs |
| Affiliation |
Digicare Health Solutions Private Limited |
| Address |
4th Floor, Plot No. 115/5, TP Scheme No. 51, off Ambli-Bopal Road, Ahmedabad, Gujarat 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
8585003316 |
| Fax |
|
| Email |
devina.aswal@tatvacare.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Modi |
| Designation |
Medical Monitor |
| Affiliation |
Digicare Health Solutions Private Limited |
| Address |
4th Floor, Plot No. 115/5, TP Scheme No. 51, off Ambli, Bopal Road, Ahmedabad, Gujarat 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
9909148706 |
| Fax |
|
| Email |
parth.modi@tatvacare.in |
|
|
Source of Monetary or Material Support
|
| Zydus Wellness Products Limited Research and Development, Plot No. 115/5, TP Scheme No. 51, Off Ambli Bopal Road, Makarba, AHMEDABAD 380058, India |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Products Limited Research and Development |
| Address |
Plot No. 115/5, TP Scheme No. 51,
Off Ambli Bopal Road, Makarba, AHMEDABAD-380058 |
| Type of Sponsor |
Other [Health/Wellness] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Banshi Saboo |
DiaCare Reserach |
Department of Endocrinology, 1-2 Gandhi Park, near Nehrunagar cross road, Ambawadi
Ahmadabad
GUJARAT |
9824047676
banshisaboo@hotmail.com |
| Dr Shaila Jay Shah |
Gujarat Cancer Society Medical College, Hospital and Research Centre |
Department of General Medicine, Opposite DRM office, Naroda road, near Chamunda Bridge
Ahmadabad
GUJARAT |
9825985529
shailashah05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Gujarat Cancer Society Medical College, Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complan Viemax high protein nutritional powder (in
150 ml water) with Lifestyle Intervention (Diet, Exercise and Cognitive
Behaviour Therapy) through GoodFlip Application |
Patients will receive Complan Viemax High Protein Nutritional Powder mixed in 150 ml of water once daily for 12 weeks. Along with this, they will follow a structured lifestyle intervention that includes diet, exercise, and cognitive behavior therapy (CBT) delivered through the GoodFlip Application for a period of 12 weeks. |
| Comparator Agent |
Lifestyle Intervention (Diet, Exercise and Cognitive
Behaviour Therapy) through GoodFlip Application |
Patients will receive standard lifestyle intervention sessions covering diet, exercise, and cognitive behaviour therapy, with access to the GoodFlip application for a period of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged more than or equal to 40 years.
2. Individuals with hand grip strength less than 27.5 kg for men and 18 kg for women.
3. Individuals with HbA1c levels less than or equal to 6.4 mg/dL.
4. Individuals with a Body Mass Index of more than or equal to 23.0 kg/m².
5. Willingness to incorporate the recommended nutritional powder into their daily diet as per the study protocol.
6. Patients with access to a smartphone with an internet connection.
7. Patients who understand and speak English sufficiently to use the GoodFlip application.
8. Patients who are willing to comply with all study procedures and will be available for the duration of the study.
9. Ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Severe renal or hepatic impairment or any other severe/uncontrolled chronic condition.
2. Individuals with HbA1c more than or equal to 6.5 mg/dL.
3. Individuals with a known allergy or intolerance to milk, soy and nuts.
4. Individuals with hyperuricemia or gout.
5. Pregnant or breastfeeding women.
6. Individuals who have participated in another clinical trial within the last 30 days. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the improvement in hand grip strength, measured using a dynamometer, from baseline to follow-up, and compare changes both within and between the intervention and comparator arms.
2. To evaluate the improvement in Skeletal Muscle Mass Index (SMMI), assessed using a Body Composition Analyzer (BCA), and compare changes both within and between the intervention and comparator arms. |
At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the improvement in gut health, assessed using the Digestion associated Quality of Life Questionnaire (DQLQ), from baseline to the
end 4, 8, and 12 weeks and compared both within and between the intervention and comparator arms at the clinical site.
2. To evaluate the improvement in fatigue severity, measured by the Visual Analogue Fatigue Scale (VAFS), from baseline to the end of 4, 8, and 12
weeks and compare both within and between the intervention and comparator arms at the clinical site.
3. To evaluate the effect on body weight from baseline to the end of 4, 8, and 12 weeks and compare both within and between the intervention and
comparator arms using a Body Composition Analyzer (BCA) at the clinical site
4. To evaluate Safety by recording and analyzing all adverse events (AEs)
reported by patients or observed during clinical examinations at site and
throughout the study. |
At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This study is a prospective, randomized, double-arm, multicenter, real-world evidence trial designed to assess the effectiveness of Complan VieMax, a high-protein nutritional powder, in enhancing muscle strength and muscle mass among adults aged 40 years and above with low baseline hand grip strength. The study aims to bridge the gap between clinical efficacy and real-world performance of nutritional supplementation in improving musculoskeletal health in aging individuals. Participants will be randomized in a 1:1 ratio into two groups. The intervention group will receive Complan VieMax (40 grams dissolved in 150 ml water once daily) along with a structured lifestyle intervention comprising diet, exercise, and cognitive behavioral therapy (CBT), all delivered digitally via the GoodFlip mobile application. The comparator group will receive only the lifestyle intervention through the GoodFlip App, without the nutritional supplement. Both groups will continue their regular diet. The trial will run over a period of 12 weeks post-enrollment. Follow-up assessments will be conducted at baseline, and at the end of weeks 4, 8, and 12. The primary endpoints are the change in hand grip strength (measured using a dynamometer) and skeletal muscle mass index. Secondary endpoints include evaluation of fatigue severity (via Visual Analogue Fatigue Scale), gut health (via Digestive Quality of Life Questionnaire), body weight, and safety based on adverse event monitoring. The study will enroll 140 participants and is sponsored by Zydus Wellness Products Limited. |