Effectiveness of Cosmos caudatus Extract in Improving Health-Related Parameters among Older Adults with Sarcopenia: A Study Protocol
Article Sidebar
Issue
Vol. 19 No. 2 (2024)
Accepted
1 July 2024
Published
30 July 2024
Keywords:
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Cosmos caudatus, Older adults, Randomized controlled trial, Sarcopenia
Abstract
This is a randomized, two-arm, double-blind, placebo-controlled study that will be performed among older adults in Kelantan, Malaysia, for 12 weeks. This study aims to determine the effectiveness of a 12-week Cosmos caudatus (C. caudatus) extract supplementation on dietary intake, cognition, mental health, sleep quality, disability, gut microbiota, physical activity, frailty, metabolites, and protein synthesis pathways among older adults with sarcopenia. This study will involve 64 older adults diagnosed with sarcopenia that will be enrolled and randomly allocated with 1:1 ratio, where 32 subjects required in both intervention and placebo group. The intervention group will receive 500 mg/day of C. caudatus supplementation, while the placebo group will be given 500 mg/day of maltodextrin. Study outcomes including sarcopenia status, dementia, motoric cognitive risk, dietary pattern, anthropometric data, physical fitness, mental health, disability and sleep quality will be measured. Blood will be taken for analysis of protein synthesis pathways (using blood plasma) and untargeted metabolomics at baseline and the 12th week. Fecal sample will be collected from a subsample of 24 subjects for gut microbiota analysis. This study is one of the pioneers randomized controlled trials to evaluate C. caudatus efficacy on various health related outcomes among sarcopenic community-dwelling elderly. This study findings are hoped to have the potential to improve health awareness of ulam or fresh salad consumption, specifically C. caudatus and prove its effectiveness as a nutraceutical product for older adults with sarcopenia. The Australian New Zealand Clinical Trials Registry (ANZCTR) has this trial listed as registered with code (ACTRN12623000046606p).
References
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Bohannon RW, Crouch RH. 2019. Two-minute step test of exercise capacity: Systematic review of procedures, performance, and clinimetric properties. J Geriatr Phys Ther 42(2):105‒112. https://doi.org/10.1519/JPT.0000000000000164
Chan YH. 2003. Randomised Controlled Trials (RCTs) sample size: The magic number? Singapore Med J 44(4):172‒174.
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S et al. 2020. Asian working group for sarcopenia: 2019 Consensus update on sarcopenia diagnosis and treatment. J Am Med Dir Assoc 21(3):300‒307. https://doi.org/10.1016/j.jamda.2019.12.012
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Cheng SH, Ismail A, Anthony J, Ng OC, Hamid AA, Yusof BNM. 2016. Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial. BMC Complement Altern Med 16(1):1‒8. https://doi.org/10.1186/s12906-016-1047-7
Fakhruddin NNIM, Shahar S, Rajikan R, Omar MA, Din NC, Razali R, Harith S, Mohamed HJJ, Hakim BNA. 2019. Identification of dietary patterns associated with characteristics of successful aging. Malays J Nutr 25(1):47‒58. https://doi.org/10.31246/nutriweb-2018-0052
Farah NM, Saw Yee T, Mohd Rasdi HF. 2019. Self-reported sleep quality using the Malay version of the Pittsburgh Sleep Quality Index (PSQI-M) in Malaysian adults. Int J Environ Res Public Health 16(23):1‒10. https://doi.org/10.3390/ijerph16234750
Gao K, Ma W, Huck S, Huck S, Li BL, Zhang L, Zhu J, Li T, Zhou D. 2021. Association Between sarcopenia and depressive symptoms in Chinese older adults: Evidence from the China health and retirement longitudinal study. Front Med 8:755705. https://doi.org/10.3389/fmed.2021.755705
Ibrahim NA, Osman ZJ, Jan KONN, Ismail SIF, Kar PC, Mukhtar F, Sidik SM. 2014. Reliability and factor structure of the general health questionnaire-12 among university students. Malays J Med Health Sci 10(2):53‒60.
Jailani M, Elias SM, Rajikan R. 2021. the new standardized Malaysian healthy eating index. Nutrients 13(10):3474. https://doi.org/10.3390/nu13103474.
Jaleel A, Halvatsiotis P, Williamson B, Juhasz P, Martin S, Nair KS. 2005. identification of amadori-modified plasma proteins in type 2 diabetes and the effect of short-term intensive insulin treatment. Diabetes Care 28(3):645‒652. https://doi.org/10.2337/diacare.28.3.645
Kadar M, Ibrahim S, Razaob NA, Chai SC, Harun D. 2018. Validity and reliability of a malay version of the lawton instrumental activities of daily living scale among the Malay speaking elderly in Malaysia. Aust Occup Ther J 65(1):63‒68. https://doi.org/10.1111/1440-1630.12441
Kim HK, Suzuki T, Saito K, Yoshida, H, Kobayashi H, Kato H, Katayama M. 2012. Effects of exercise and amino acid supplementation on body composition and physical function in community-dwelling elderly Japanese sarcopenic women: A randomized controlled trial. J Am Geriatr Soc 60(1):16‒23. https://doi.org/10.1111/j.1532-5415.2011.03776.x
Le NH, Kim CS, Park T, Park JHY, Sung MK, Lee DG, Hong SM, Choe SY, Goto T, Kawada T, Yu R. 2014. Quercetin protects against obesity-induced skeletal muscle inflammation and atrophy. Mediators Inflamm 2014(1):834294. https://doi.org/10.1155/2014/834294
Liu W, Puts M, Jiang F, Zhou C, Tang S, Chen S. 2020. Physical frailty and its associated factors among elderly nursing home residents in China. BMC Geriatr 294:1‒9. https://doi.org/10.21203/rs.3.rs-36416/v1
Makizako H, Shimada H, Tsutsumimoto K, Lee S, Doi T, Nakakubo S, Hotta R, Suzuki T. 2015. Social frailty in community-dwelling older adults as a risk factor for disability. J Am Med Dir Assoc 16(11):1003‒e7. https://doi.org/10.1016/j.jamda.2015.08.023
Mayorga-Vega D, Merino-Marban R, Viciana J. 2014. Criterion-related validity of sit-and-reach tests for estimating hamstring and lumbar extensibility: A meta-analysis. J Sci Med Sport 13(1):1‒14.
Mayrink J, Souza RT, Silveira C, Guida JP, Costa ML, Parpinelli MA, Pacagnella RC, Ferreira, EC, Sousa MH, Say L et al. 2018. Reference ranges of the WHO Disability Assessment Schedule (WHODAS 2.0) score and diagnostic validity of its 12-item version in identifying altered functioning in healthy postpartum women. Int J Gynecol Obstet 141:48‒54. https://doi.org/10.1002/ijgo.12466
Mohamed Fuad Z, Mahadzir H, Syed Zakaria SZ, Mohamed Ibrahim N. 2020. Frequency of cognitive impairment among Malaysian elderly patients following first ischaemic stroke-A Case control study. Front Public Health 8:577940. https://doi.org/10.3389/fpubh.2020.577940
Mohd Hamidin FA, Adznam SNA, Ibrahim Z, Chan YM, Abdul Aziz NH. 2018. Prevalence of frailty syndrome and its associated factors among community-dwelling elderly in east coast of Peninsular Malaysia. SAGE Open Med 6:2050312118775581. https://doi.org/10.1177/2050312118775581
Moshawih S, Cheema MS, Ahmad Z, Zakaria ZA, Hakim MN. 2017. A comprehensive review on Cosmos caudatus (Ulam Raja): Pharmacology, ethnopharmacology, and phytochemistry. Int J Educ Res 1(1):14‒31.
Mostafa H, Mohd Amin A, Arif N, Ibrahim B. 2017. Nuclear magnetic resonance spectroscopy based metabolomics to identify novel biomarkers of alcohol-dependence. Songklanakarin J Sci Technol 39(2):153‒162.
Nikawa T, Ulla A, Sakakibara I. 2021. Polyphenols and their effects on muscle atrophy and muscle health. Molecules 26(4887). https://doi.org/10.3390/molecules26164887
Papadopoulou SK. 2020. Sarcopenia: A contemporary health problem among older adult populations. Nutrients 12(5):1293. https://doi.org/10.3390/nu12051293
Qaisar R, Karim A, Muhammad T, Shah I, Khan J. 2021. Prediction of sarcopenia using a battery of circulating biomarkers. Sci Rep 11(1):8632. https://doi.org/10.1038/s41598-021-87974-6
Ramoo K, Hairi NN, Yahya A, Choo WY, Hairi FM, Peramalah D, Kandiben S, Bulgiba A, Ali ZM, Razak IA et al. 2022. Longitudinal association between sarcopenia and cognitive impairment among older adults in rural Malaysia. Int J Environ Res Public Health 19(8):4723. https://doi.org/10.3390/ijerph19084723
Razali R, Jean-Li L, Jaffar A, Ahmad M, Shah SA, Ibrahim N, Din NC, Jaafar NRN, Midin M, Sidi H et al. 2014. Is the Bahasa Malaysia version of the Montreal Cognitive Assessment (MoCA-BM) a better instrument than the Malay version of the Mini Mental State Examination (M-MMSE) in screening for Mild Cognitive Impairment (MCI) in the elderly? Compr Psychiatry 2 55(1):S70‒S75. https://doi.org/10.1016/j.comppsych.2013.04.010
Seiler HL, Kolle E, Anderssen SA, Hansen BH. 2016. Musculoskeletal fitness and balance in older individuals (65‒85 Years) and its association with steps per day: A cross sectional study. BMC Geriatr 16(6). https://doi.org/10.1186/s12877-016-0188-3
Shahar S, Pooy NS. 2003. Predictive equations for estimation of stature in Malaysian elderly people. Asia Pac J Clin Nutr 12(1):80‒84.
Singh KK, Gupta A, Bharti C, Sharma H. 2021. Emerging techniques of western blotting for purification and analysis of protein. Future J Pharm Sci 7(239):1‒14. https://doi.org/10.1186/s43094-021-00386-1
Verghese J, Wang C, Lipton RB et al. 2013. Motoric cognitive risk syndrome and the risk of dementia. The Journals of Gerontology: Series A 68(4):412–418. https://doi.org/10.1093/gerona/gls191
Williams N. 2017. The Borg Rating of Perceived Exertion (RPE) scale. Occup Med 67(5):404‒405. https://doi.org/10.1093/occmed/kqx063
You YX, Shahar S, Haron H, Yahya HM. 2018. More ulam for your brain : A review on the potential role of ulam in protecting against cognitive decline. Sains Malays 47(11):2713‒2729. https://doi.org/10.17576/jsm-2018-4711-15
You YX, Shahar S, Rajab NF, Haron H, Yahya HM, Mohamad M, Din NC, Maskat MY. 2021. Effects of 12 weeks cosmos caudatus supplement among older adults with mild cognitive impairment: A Randomized, double-blind and placebo-controlled trial. Nutrients 13(434):1‒16. https://doi.org/10.3390/nu13020434
Yusoff NAH, Sanuan FM, Rukayadi Y. 2015. Cosmos caudatus Kunth. Extract reduced number of microflora in oyster mushroom (Pleurotus Ostreatus). Int Food Res J 22(5):1837‒1842.
Aurelia PL, Gabriela DOGARU, Valer D. 2015. Sarcopenia: Diagnosis, stages and treatment. Balneo PRM Res J 6(1):32‒35. https://doi.org/10.12680/balneo.2015.1082
Bohannon RW, Crouch RH. 2019. Two-minute step test of exercise capacity: Systematic review of procedures, performance, and clinimetric properties. J Geriatr Phys Ther 42(2):105‒112. https://doi.org/10.1519/JPT.0000000000000164
Chan YH. 2003. Randomised Controlled Trials (RCTs) sample size: The magic number? Singapore Med J 44(4):172‒174.
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S et al. 2020. Asian working group for sarcopenia: 2019 Consensus update on sarcopenia diagnosis and treatment. J Am Med Dir Assoc 21(3):300‒307. https://doi.org/10.1016/j.jamda.2019.12.012
Cheng SH, Mohd Yusof BN, Anthony J, Ismail A. 2015. Potential medicinal benefits of Cosmos caudatus (Ulam Raja): A scoping review. Res J Med Sci 20(10):1000‒1006. https://doi.org/10.4103/1735-1995.172796
Cheng SH, Ismail A, Anthony J, Ng OC, Hamid AA, Yusof BNM. 2016. Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial. BMC Complement Altern Med 16(1):1‒8. https://doi.org/10.1186/s12906-016-1047-7
Fakhruddin NNIM, Shahar S, Rajikan R, Omar MA, Din NC, Razali R, Harith S, Mohamed HJJ, Hakim BNA. 2019. Identification of dietary patterns associated with characteristics of successful aging. Malays J Nutr 25(1):47‒58. https://doi.org/10.31246/nutriweb-2018-0052
Farah NM, Saw Yee T, Mohd Rasdi HF. 2019. Self-reported sleep quality using the Malay version of the Pittsburgh Sleep Quality Index (PSQI-M) in Malaysian adults. Int J Environ Res Public Health 16(23):1‒10. https://doi.org/10.3390/ijerph16234750
Gao K, Ma W, Huck S, Huck S, Li BL, Zhang L, Zhu J, Li T, Zhou D. 2021. Association Between sarcopenia and depressive symptoms in Chinese older adults: Evidence from the China health and retirement longitudinal study. Front Med 8:755705. https://doi.org/10.3389/fmed.2021.755705
Ibrahim NA, Osman ZJ, Jan KONN, Ismail SIF, Kar PC, Mukhtar F, Sidik SM. 2014. Reliability and factor structure of the general health questionnaire-12 among university students. Malays J Med Health Sci 10(2):53‒60.
Jailani M, Elias SM, Rajikan R. 2021. the new standardized Malaysian healthy eating index. Nutrients 13(10):3474. https://doi.org/10.3390/nu13103474.
Jaleel A, Halvatsiotis P, Williamson B, Juhasz P, Martin S, Nair KS. 2005. identification of amadori-modified plasma proteins in type 2 diabetes and the effect of short-term intensive insulin treatment. Diabetes Care 28(3):645‒652. https://doi.org/10.2337/diacare.28.3.645
Kadar M, Ibrahim S, Razaob NA, Chai SC, Harun D. 2018. Validity and reliability of a malay version of the lawton instrumental activities of daily living scale among the Malay speaking elderly in Malaysia. Aust Occup Ther J 65(1):63‒68. https://doi.org/10.1111/1440-1630.12441
Kim HK, Suzuki T, Saito K, Yoshida, H, Kobayashi H, Kato H, Katayama M. 2012. Effects of exercise and amino acid supplementation on body composition and physical function in community-dwelling elderly Japanese sarcopenic women: A randomized controlled trial. J Am Geriatr Soc 60(1):16‒23. https://doi.org/10.1111/j.1532-5415.2011.03776.x
Le NH, Kim CS, Park T, Park JHY, Sung MK, Lee DG, Hong SM, Choe SY, Goto T, Kawada T, Yu R. 2014. Quercetin protects against obesity-induced skeletal muscle inflammation and atrophy. Mediators Inflamm 2014(1):834294. https://doi.org/10.1155/2014/834294
Liu W, Puts M, Jiang F, Zhou C, Tang S, Chen S. 2020. Physical frailty and its associated factors among elderly nursing home residents in China. BMC Geriatr 294:1‒9. https://doi.org/10.21203/rs.3.rs-36416/v1
Makizako H, Shimada H, Tsutsumimoto K, Lee S, Doi T, Nakakubo S, Hotta R, Suzuki T. 2015. Social frailty in community-dwelling older adults as a risk factor for disability. J Am Med Dir Assoc 16(11):1003‒e7. https://doi.org/10.1016/j.jamda.2015.08.023
Mayorga-Vega D, Merino-Marban R, Viciana J. 2014. Criterion-related validity of sit-and-reach tests for estimating hamstring and lumbar extensibility: A meta-analysis. J Sci Med Sport 13(1):1‒14.
Mayrink J, Souza RT, Silveira C, Guida JP, Costa ML, Parpinelli MA, Pacagnella RC, Ferreira, EC, Sousa MH, Say L et al. 2018. Reference ranges of the WHO Disability Assessment Schedule (WHODAS 2.0) score and diagnostic validity of its 12-item version in identifying altered functioning in healthy postpartum women. Int J Gynecol Obstet 141:48‒54. https://doi.org/10.1002/ijgo.12466
Mohamed Fuad Z, Mahadzir H, Syed Zakaria SZ, Mohamed Ibrahim N. 2020. Frequency of cognitive impairment among Malaysian elderly patients following first ischaemic stroke-A Case control study. Front Public Health 8:577940. https://doi.org/10.3389/fpubh.2020.577940
Mohd Hamidin FA, Adznam SNA, Ibrahim Z, Chan YM, Abdul Aziz NH. 2018. Prevalence of frailty syndrome and its associated factors among community-dwelling elderly in east coast of Peninsular Malaysia. SAGE Open Med 6:2050312118775581. https://doi.org/10.1177/2050312118775581
Moshawih S, Cheema MS, Ahmad Z, Zakaria ZA, Hakim MN. 2017. A comprehensive review on Cosmos caudatus (Ulam Raja): Pharmacology, ethnopharmacology, and phytochemistry. Int J Educ Res 1(1):14‒31.
Mostafa H, Mohd Amin A, Arif N, Ibrahim B. 2017. Nuclear magnetic resonance spectroscopy based metabolomics to identify novel biomarkers of alcohol-dependence. Songklanakarin J Sci Technol 39(2):153‒162.
Nikawa T, Ulla A, Sakakibara I. 2021. Polyphenols and their effects on muscle atrophy and muscle health. Molecules 26(4887). https://doi.org/10.3390/molecules26164887
Papadopoulou SK. 2020. Sarcopenia: A contemporary health problem among older adult populations. Nutrients 12(5):1293. https://doi.org/10.3390/nu12051293
Qaisar R, Karim A, Muhammad T, Shah I, Khan J. 2021. Prediction of sarcopenia using a battery of circulating biomarkers. Sci Rep 11(1):8632. https://doi.org/10.1038/s41598-021-87974-6
Ramoo K, Hairi NN, Yahya A, Choo WY, Hairi FM, Peramalah D, Kandiben S, Bulgiba A, Ali ZM, Razak IA et al. 2022. Longitudinal association between sarcopenia and cognitive impairment among older adults in rural Malaysia. Int J Environ Res Public Health 19(8):4723. https://doi.org/10.3390/ijerph19084723
Razali R, Jean-Li L, Jaffar A, Ahmad M, Shah SA, Ibrahim N, Din NC, Jaafar NRN, Midin M, Sidi H et al. 2014. Is the Bahasa Malaysia version of the Montreal Cognitive Assessment (MoCA-BM) a better instrument than the Malay version of the Mini Mental State Examination (M-MMSE) in screening for Mild Cognitive Impairment (MCI) in the elderly? Compr Psychiatry 2 55(1):S70‒S75. https://doi.org/10.1016/j.comppsych.2013.04.010
Seiler HL, Kolle E, Anderssen SA, Hansen BH. 2016. Musculoskeletal fitness and balance in older individuals (65‒85 Years) and its association with steps per day: A cross sectional study. BMC Geriatr 16(6). https://doi.org/10.1186/s12877-016-0188-3
Shahar S, Pooy NS. 2003. Predictive equations for estimation of stature in Malaysian elderly people. Asia Pac J Clin Nutr 12(1):80‒84.
Singh KK, Gupta A, Bharti C, Sharma H. 2021. Emerging techniques of western blotting for purification and analysis of protein. Future J Pharm Sci 7(239):1‒14. https://doi.org/10.1186/s43094-021-00386-1
Verghese J, Wang C, Lipton RB et al. 2013. Motoric cognitive risk syndrome and the risk of dementia. The Journals of Gerontology: Series A 68(4):412–418. https://doi.org/10.1093/gerona/gls191
Williams N. 2017. The Borg Rating of Perceived Exertion (RPE) scale. Occup Med 67(5):404‒405. https://doi.org/10.1093/occmed/kqx063
You YX, Shahar S, Haron H, Yahya HM. 2018. More ulam for your brain : A review on the potential role of ulam in protecting against cognitive decline. Sains Malays 47(11):2713‒2729. https://doi.org/10.17576/jsm-2018-4711-15
You YX, Shahar S, Rajab NF, Haron H, Yahya HM, Mohamad M, Din NC, Maskat MY. 2021. Effects of 12 weeks cosmos caudatus supplement among older adults with mild cognitive impairment: A Randomized, double-blind and placebo-controlled trial. Nutrients 13(434):1‒16. https://doi.org/10.3390/nu13020434
Yusoff NAH, Sanuan FM, Rukayadi Y. 2015. Cosmos caudatus Kunth. Extract reduced number of microflora in oyster mushroom (Pleurotus Ostreatus). Int Food Res J 22(5):1837‒1842.
Authors
NazriN. S., VanohD., MurugaiyahV., IbrahimB., KannanT. P., Wan IshakW. R., & ShaharS. (2024). Effectiveness of Cosmos caudatus Extract in Improving Health-Related Parameters among Older Adults with Sarcopenia: A Study Protocol . Jurnal Gizi Dan Pangan, 19(2), 87-89. https://doi.org/10.25182/jgp.2024.19.2.87-89
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