Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000046606p
Ethics application status
Submitted, not yet approved
Date submitted
17/12/2022
Date registered
16/01/2023
Date last updated
16/01/2023
Date data sharing statement initially provided
16/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Cosmos caudatus Extract Supplementation on Various Health Related Parameters among Older Adults with Muscle Loss
Scientific title
Effect of Cosmos caudatus Extract Supplementation on Various Health Related Parameters among Older Adults with Sarcopenia
Secondary ID [1] 308432 0
Ministry of Higher Education Malaysia for Fundamental Research Grant Scheme (FRGS) with project code: FRGS/1/2022/SKK06/USM/02/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 328543 0
Poor dietary intake 328544 0
Cognitive impairment 328545 0
depression 328546 0
Poor sleep quality 328547 0
disability 328548 0
Frailty 328549 0
Condition category
Condition code
Alternative and Complementary Medicine 325561 325561 0 0
Herbal remedies
Diet and Nutrition 325562 325562 0 0
Other diet and nutrition disorders
Mental Health 325563 325563 0 0
Depression
Musculoskeletal 325564 325564 0 0
Other muscular and skeletal disorders
Neurological 325565 325565 0 0
Dementias
Neurological 325660 325660 0 0
Other neurological disorders
Mental Health 325661 325661 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325098 0
Treatment: Other
Comparator / control treatment
Control group will receive oral capsule of 500mg of maltodextrin (1 capsule per day) for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 333400 0
Change in dietary intake assessed by Diet History Questionnaire (DHQ)
Timepoint [1] 333400 0
Baseline, 6th week and 12th week changes in dietary intake of intervention
Primary outcome [2] 333401 0
Change in sarcopenia indices based on Asian Working Group for Sarcopenia (AWGS) diagnosis criteria including:

1. Handgrip strength assessed using hydraulic hand dynamometer
2. Physical performance assessed using Short Physical Performance Battery (SPPB)
3. Muscle mass measured using the Karada Scan Omron Body Composition Monitor HBF-214

All indices will be analyzed together as a composite primary outcome.
Timepoint [2] 333401 0
Baseline, 6th week and 12th week changes in handgrip strength, physical performance and muscle mass of intervention
Primary outcome [3] 333402 0
Changes in physical frailty assessed using Fried physical phenotype
Timepoint [3] 333402 0
Baseline, 6th week and 12th week changes in physical frailty of intervention
Secondary outcome [1] 416929 0
Changes in motoric cognitive risk syndrome which have 4 criteria including:
1. absence of dementia
2. subjective cognitive decline
3. slow gait
4. preserved activities of daily living

- Dementia assessed using the Montreal Cognitive Assessment (MoCA).
- Subjective cognitive decline assessed using item 10 in Geriatric Depression Scale (GDS-15) which is “Do you feel you have more problems with memory than most?”
- Gait speed assessed using a 6 meter walk test.
-Activities of daily living assessed using instrumental activities of daily living in Malay version (IADL MV) questionnaire.

All components of motoric cognitive risk syndrome will be analyzed together as a composite secondary outcome.
Timepoint [1] 416929 0
Baseline, 6th week and 12th week changes in motoric cognitive risk syndrome of intervention
Secondary outcome [2] 416930 0
Changes in mental health assessed by General Health Questionnaire (GHQ)
Timepoint [2] 416930 0
Baseline, 6th week and 12th week changes in mental health of intervention
Secondary outcome [3] 416931 0
Changes in sleep quality assessed by using Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 416931 0
Baseline, 6th week and 12th week changes in sleep quality of intervention
Secondary outcome [4] 416932 0
Changes in disability assessed using the WHO Disability Assessment Schedule (WHODAS)
Timepoint [4] 416932 0
Baseline, 6th week and 12th week changes in disability of intervention
Secondary outcome [5] 416933 0
Changes in cognitive frailty which have 3 criteria including:

1. Physical frailty assessed using Fried physical phenotype
2. Cognitive impairment assessed using MoCA
3. Functional limitation assessed using IADL

All components of cognitive frailty will be analyzed together as a composite secondary outcome.
Timepoint [5] 416933 0
Baseline, 6th week and 12th week changes in cognitive frailty of intervention
Secondary outcome [6] 416934 0
Changes in gut microbiota in stool samples analyzed using Illumina Nextseq. 12 participants from each group will be randomly selected, only participants who agree for stool collection will be recruited
Timepoint [6] 416934 0
Baseline and 12th week changes in gut microbiota of intervention
Secondary outcome [7] 416937 0
changes in protein synthesis pathway (IGF1-Akt-mTOR pathway) in blood samples assessed using Western blot analysis
Timepoint [7] 416937 0
Baseline and 12th week changes in protein synthesis pathway of intervention
Secondary outcome [8] 416938 0
Changes in metabolomic pathways in blood sample using nuclear magnetic resonance (NMR) spectroscopy. This is an exploratory outcome.
Timepoint [8] 416938 0
Baseline and 12th week changes in metabolomic pathways of intervention
Secondary outcome [9] 417293 0
Changes in upper body flexibility assessed using back scratch test
Timepoint [9] 417293 0
Baseline, 6th week and 12th week of changes in upper body flexibility of intervention
Secondary outcome [10] 417294 0
Changes in aerobic capacity assessed using 2-minute step test (the number of times the right knee reaching the point of midway between the patella and iliac crest within 2 minutes)
Timepoint [10] 417294 0
Baseline. 6th week and 12th week changes in aerobic capacity of intervention
Secondary outcome [11] 417295 0
Changes in lower body flexibility assessed using chair sit-and-reach test
Timepoint [11] 417295 0
Baseline, 6th week and 12th week of changes in lower body flexibility of intervention
Secondary outcome [12] 417296 0
Changes in back and leg strength assessed using back-and-leg dynamometer
Timepoint [12] 417296 0
Baseline, 6th week and 12th week changes in back and eg strength of intervention
Secondary outcome [13] 417305 0
Changes in Borg Rating of Perceived Exertion scale to measure individual's effort and exertion, breathlessness and fatigue during physical work. This scale will be assessed after all the physical fitness test including Short Physical Performance Battery (SPPB), handgrip test, back scratch test, 2-minute step test, chair sit and reach test and back-and-leg strength test
Timepoint [13] 417305 0
Baseline, 6th week and 12th week changes in Borg Rating of Perceived Exertion scale of intervention
Secondary outcome [14] 417306 0
Changes in blood pressure assessed using the Omron Digital Blood Pressure Monitor
Timepoint [14] 417306 0
Baseline, 6th week and 12th week changes in blood pressure of intervention
Secondary outcome [15] 417307 0
Changes in weight measured using the Karada Scan Omron Body Composition Monitor HBF-214
Timepoint [15] 417307 0
Baseline, 6th week and 12th week changes in weight of intervention
Secondary outcome [16] 417308 0
Changes in height measured using stadiometer
Timepoint [16] 417308 0
Baseline, 6th week and 12th week changes in height of intervention
Secondary outcome [17] 417309 0
Changes in calf circumference measured using measuring tape
Timepoint [17] 417309 0
Baseline, 6th week and 12th week changes in calf circumference of intervention

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the container for both treatment and placebo capsules will be labeled 'A' and 'B' for allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence of the subjects will be generated using a randomization website (https://www.randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using Statistical Package for the Social Sciences (SPSS) version 26 (SPSS Inc, Chicago, USA). For continuous data, it will be presented in mean ± SD whereas categorical data presented in percentage. Normality test will be done using Shapiro-Wilk test prior to univariate analysis. For baseline analysis, the difference of study outcome between the sarcopenic treatment and control group will be compared using independent t-test. The effectiveness of the Cosmos caudatus supplementation will be assessed using the two-way repeated measure ANOVA adjusted for possible confounding factors. The significance level (a) will be set at 0.05 while the confidence level is at 95% for the test and p-value <0.05 will be considered significant

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 25187 0
Malaysia
State/province [1] 25187 0
Kelantan

Funding & Sponsors
Funding source category [1] 312680 0
Government body
Name [1] 312680 0
Fundamental Research Grant Scheme (FRGS) by Ministry of Higher Education Malaysia
Country [1] 312680 0
Malaysia
Primary sponsor type
Individual
Name
Divya Vanoh
Address
Dietetics Programme, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country
Malaysia
Secondary sponsor category [1] 314290 0
Individual
Name [1] 314290 0
Nurul Syahidah Nazri
Address [1] 314290 0
School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country [1] 314290 0
Malaysia
Secondary sponsor category [2] 314539 0
Individual
Name [2] 314539 0
Keerthana Sree Ganggaya
Address [2] 314539 0
School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country [2] 314539 0
Malaysia
Secondary sponsor category [3] 314540 0
Individual
Name [3] 314540 0
Nur Syakirah Arissa Mohd Salleh
Address [3] 314540 0
School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country [3] 314540 0
Malaysia
Secondary sponsor category [4] 314541 0
Individual
Name [4] 314541 0
Vickenswaran Murugaiyah
Address [4] 314541 0
School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Gelugor, Penang.
Country [4] 314541 0
Malaysia
Secondary sponsor category [5] 314542 0
Individual
Name [5] 314542 0
Baharuddin Ibrahim
Address [5] 314542 0
School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Gelugor, Penang.
Country [5] 314542 0
Malaysia
Secondary sponsor category [6] 314543 0
Individual
Name [6] 314543 0
TP Kannan
Address [6] 314543 0
School of Dental Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country [6] 314543 0
Malaysia
Secondary sponsor category [7] 314544 0
Individual
Name [7] 314544 0
Wan Rosli Wan Ishak
Address [7] 314544 0
School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan
Country [7] 314544 0
Malaysia
Secondary sponsor category [8] 314545 0
Individual
Name [8] 314545 0
Suzana Shahar
Address [8] 314545 0
Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [8] 314545 0
Malaysia
Secondary sponsor category [9] 314546 0
Individual
Name [9] 314546 0
Sakinah Harith
Address [9] 314546 0
School of Nutrition and Dietetics, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu
Country [9] 314546 0
Malaysia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311982 0
Human Research Ethics Committee Universiti Sains Malaysia (USM)
Ethics committee address [1] 311982 0
Division of Research & Innovation (R&I),
USM Health Campus,
16150, Kubang Kerian,
Kelantan.
Ethics committee country [1] 311982 0
Malaysia
Date submitted for ethics approval [1] 311982 0
17/08/2022
Approval date [1] 311982 0
Ethics approval number [1] 311982 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123054 0
Dr Divya Vanoh
Address 123054 0
Dietetics Programme,
School of Health Sciences,
Universiti Sains Malaysia, Health Campus,
16150 Kubang Kerian,
Kelantan.
Country 123054 0
Malaysia
Phone 123054 0
+60137790208
Fax 123054 0
Email 123054 0
divyavanoh@usm.my
Contact person for public queries
Name 123055 0
Mrs Nurul Syahidah Nazri
Address 123055 0
School of Health Sciences,
Universiti Sains Malaysia, Health Campus,
16150 Kubang Kerian,
Kelantan.
Country 123055 0
Malaysia
Phone 123055 0
+60197034900
Fax 123055 0
Email 123055 0
syahidahnazri@student.usm.my
Contact person for scientific queries
Name 123056 0
Dr Divya Vanoh
Address 123056 0
Dietetics Programme,
School of Health Sciences,
Universiti Sains Malaysia, Health Campus,
16150 Kubang Kerian,
Kelantan.
Country 123056 0
Malaysia
Phone 123056 0
+60137790208
Fax 123056 0
Email 123056 0
divyavanoh@usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our ethical committee requested us to be confidential with the research data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.