Effect of Cosmos caudatus Extract Supplementation on Various Health Related Parameters among Older Adults with Muscle Loss

Not Applicable

Not yet recruiting

• Conditions: Sarcopenia; Poor dietary intake; Cognitive impairment; depression; Poor sleep quality; disability; Frailty; Alternative and Complementary Medicine - Herbal remedies; Diet and Nutrition - Other diet and nutrition disorders; Mental Health - Depression

• Registration Number: ACTRN12623000046606
• Lead Sponsor: Divya Vanoh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in dietary intake assessed by Diet History Questionnaire (DHQ) [Baseline, 6th week and 12th week changes in dietary intake of intervention];Change in sarcopenia indices based on Asian Working Group for Sarcopenia (AWGS) diagnosis criteria including:<br><br>1. Handgrip strength assessed using hydraulic hand dynamometer <br>2. Physical performance assessed using Short Physical Performance Battery (SPPB)<br>3. Muscle mass measured using the Karada Scan Omron Body Composition Monitor HBF-214<br><br>All indices will be analyzed together as a composite primary outcome.[Baseline, 6th week and 12th week changes in handgrip strength, physical performance and muscle mass of intervention];Changes in physical frailty assessed using Fried physical phenotype[Baseline, 6th week and 12th week changes in physical frailty of intervention]