Effectiveness of Complan VieMax High-Protein Nutritional Powder on Muscle Strength: A Comparative Real-World Evidence study
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged more than or equal to 40 years.
- •Individuals with hand grip strength less than 27.5 kg for men and 18 kg for women.
- •Individuals with HbA1c levels less than or equal to 6.4 mg/dL.
- •Individuals with a Body Mass Index of more than or equal to 23.0 kg/m².
- •Willingness to incorporate the recommended nutritional powder into their daily diet as per the study protocol.
- •Patients with access to a smartphone with an internet connection.
- •Patients who understand and speak English sufficiently to use the GoodFlip application.
- •Patients who are willing to comply with all study procedures and will be available for the duration of the study.
- •Ability to provide informed consent.
排除标准
- •Severe renal or hepatic impairment or any other severe/uncontrolled chronic condition.
- •Individuals with HbA1c more than or equal to 6.5 mg/dL.
- •Individuals with a known allergy or intolerance to milk, soy and nuts.
- •Individuals with hyperuricemia or gout.
- •Pregnant or breastfeeding women.
- •Individuals who have participated in another clinical trial within the last 30 days.
结局指标
主要结局
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.
时间窗: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)
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.
时间窗: At Baseline, End of Week 4 (First follow-up assessment), End of Week 8 (Second follow-up assessment), End of Week 12 (Final assessment)
次要结局
- 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.)
研究者
Dr Banshi Saboo
DiaCare Research