None listed
Conditions
Brief summary
Sarcopenia is one of the most prominent issues that may restrain healthy aging among older adults. Cosmos caudatus is high in vitamin C and bioactive compounds. To date, no studies had used Cosmos caudatus as an intervention for sarcopenic older adults. Therefore, this study is done to address the research gap which is a double-blind placebo controlled randomized trial conducted to investigate the effects of 12 weeks of Cosmos caudatus supplement on dietary intake, cognition, mental health, sleep quality, disability and protein synthesis pathways among older adults with sarcopenia. A total of 64 older adults diagnosed with sarcopenia will be enrolled. Intervention group will be received 500 mg/day of C. caudatus supplementation while the placebo group will be given 500 mg/day of maltodextrin. Sarcopenia will be assessed using the Asian Working Group of Sarcopenia (AWGS) 2019. Study outcomes such as dietary pattern, physical fitness, sarcopenia indices, anthropometric data, mental health, disability and sleep quality will be measured at baseline, 6th week and 12th week. A total of 5 ml blood will be taken for protein synthesis pathways using the IGF/Akt/mTOR pathway and metabolomics at the baseline and 12th week. Fecal sample will be collected from a subsample of 24 subjects (12 from each group) for gut microbiota analysis. Analysis will be conducted using descriptive analysis, univariate analysis and two-way repeated measure ANOVA. The findings from this study hope to be able to give significant proof of the effectiveness of Cosmos caudatus as a nutraceutical product for older adults with sarcopenia.
Interventions
The treatment group will receive oral capsule of 500mg of Cosmos caudatus extract (1 capsule per day) for 12 weeks. Weekly telephone calls will be done to monitor adherence and to address the concern of subjects such as presence of any side effects after consuming Cosmos caudatus supplementation. Compliance will be monitored by the researcher by asking the subjects to return the supplement bottle every month.
Sponsors
Divya Vanoh
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Older adults aged 60 years and above who has sarcopenia diagnosed using Asian Working Group for Sarcopenia (AWGS) 2019 guidelines (only meeting 2 criteria - poor muscle mass and poor muscle strength or poor physical performance), non-smoking, not taking any other vitamin, herbal or traditional medications and not consuming fruits or vegetables or not meeting the recommended intake of 2 servings of fruits and at least 3 servings of vegetables.
Exclusion criteria
Older adults who are undergoing regular hemodialysis, bedridden, hospitalised or living in a long-term care facility, have severe sarcopenia (meeting all the three criteria of AWGS 2019 namely poor muscle strength, poor muscle quantity and poor physical performance), gastrointestinal surgery or gastrointestinal radiation therapy or chemotherapy, chronic kidney diseases, diarrhea, chronic constipation or gastrointestinal diseases (inflammatory bowel disease, irritable bowel syndrome, haemorrhoid, diverticulitis), dementia and also those who are on tube feeding or antibiotics for the past 30 days, corticosteroid, immunosuppressants, warfarin therapy or on medications affecting intestinal motility such as laxatives, antidepressants, opioid, anticholinergic, prebiotic and probiotic during the study period.
Outcome results
None listed