Effect of Protein, Prebiotic and Probiotic based Nutritional powder on Muscle Health in Adults

Effectiveness of Complan VieMax High-Protein Nutritional Powder on Muscle Strength: A Comparative Real-World Evidence study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/07/090278

Enrollment

Registered

2025-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M628- Other specified disorders of muscle

Interventions

Intervention1: Complan Viemax high protein nutritional powder (in 150 ml water) with Lifestyle Intervention (Diet, Exercise and Cognitive Behaviour Therapy) through GoodFlip Application: Patients wi

Eligibility

Inclusion criteria

Inclusion criteria: 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/m . 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)	—

Measure

Time frame

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.Timepoint: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)

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Secondary

Measure	Time frame
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.Timepoint: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)	—

Measure

Time frame

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.Timepoint: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)

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Countries

India

Contacts

Public ContactDr Parth Modi

Digicare Health Solutions Private Limited

devina.aswal@tatvacare.in8585003316

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026