Health Condition 1: R54- Age-related physical debility
Conditions
Interventions
Intervention1: Rhodiola capsule 400mg: One capsule /day every morning after food.
Control Intervention1: Placebo - microcrystalline cellulose: One capsule /day every morning after food.
Sponsors
Finzelberg GmbH and Co. KG,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age and Gender Male and female participants aged 55 years and older For female, post menopause period (Participants with an absence of menstruation for more than one year during the screening period.) 2. Physical Inactivity Individuals who have not engaged in regular physical activity in the past 6 months, defined as: Less than 150 minutes of moderate intensity activity per week No resistance or strength training during this period. 3. Early Symptoms of Muscle Weakness or Muscle Mass Loss Documented mild to moderate muscle weakness or loss of muscle mass , confirmed by SARC F questionnaire (positive for sarcopenia risk, e.g., score greater than or equal to 4). Anthropometric measurements (e.g., reduced muscle circumference or muscle mass as assessed by BIA). 4. Fatigue and Limited Physical Performance Fatigue , defined by a score of greater than or equal to 4 on the Chalder Fatigue Scale Self-reported or objectively measured limitations in physical performance (e.g., gait speed less than 1 m/s in a 4 meter walking test)- 5. No Significant Weight Loss The criterion of weight loss of more than 5 percentage of total body weight is excluded to include participants without significant weight loss but with signs of muscle weakness over a period of 3 months, BMI of 18 35 both are inclusive and minimum body weight of 50kg. 6. Motivation for Participation in an Intervention Willingness and motivation to participate in a structured exercise program (e.g., documented through self-report or screening questionnaires). 7. Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Participants with known history of a disease condition causing clinically significant fatigue or weight reduction or muscle loss (e.g. congestive cardiac failure, sleep disorders, chronic kidney disease, chronic infections, COPD, hepatitis, musculoskeletal dystrophies, cancer, diagnosed sarcopenia). 2. Hs CRP levels more than 3 mg/L 3. Currently taking medications that cause fatigue (e.g. diuretics, beta blockers, narcotics). 4. History of psychiatric disorder (e.g. major depressive disorder, bipolar disorder, anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence). 5. History of smoking and alcohol consumption. 6. History of any medical condition that limits exercise performance for selected participants (e.g. any condition with a ventilatory limitation during maximal exercise and Rheumatoid arthritis). 7. Participants with uncontrolled diabetes mellitus (HbA1c greater than 10) and uncontrolled hypertension. 8. Active participation in any other similar study or having been participated in any study within 30 days. 9. History of consumption of any other nutritional supplement in the last 3 months. And/or current intake of corrective treatment, plant- based products or dietary supplements that could interfere in the study. 10. Known hypersensitivity to one of the components of the experimental products 11. Participants who have undergone any surgery within the past 6 months during screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of Rhodiola on muscle mass (Anthropometry and BMI), muscle strength (Hand grip test), Bench Press, Leg Press, DOMS (Delayed onset muscle soreness) and Appendicular Skeletal Muscle Mass Index (ASMI). To evaluate the improvement in energy levels by measuring gait speed, chair stand test, Walking Capacity, measured as distance or speed, tested via a 6-minute walk test and 30-second sit-stand. Timepoint: Baseline, 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To measure Lean Body Mass (LBM) 2. To evaluate the improvement in energy levels by measuring VO2 max through Treadmill test for those participants who will be able to do Treadmill test 3. To measure the Quality of life using SF 36 Questionnaire. 4. To evaluate the reduction in tiredness and fatigue measured with Chalder Fatigue Scale. 5. To evaluate the reduction in stress measured with perceived stress scale. 6. To evaluate the improvement in quality of sleep measured with Jenkins sleep scale. 7. To evaluate functional strength and balance with Single-Leg Balance Test 8. To evaluate the improvement in overall wellness measured with Perceived wellness survey. 9. To measure participants social engagement with Self-efficacy for Social Participation Scale (SOSA) 10. To evaluate the improvement in biomarkers (HsCRP, Testosterone levels) at Day 0 and week 12 only 11. Adverse event monitoring Timepoint: Baseline, 8 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 PRIVATE LIMITED
Outcome results
None listed