Labisia pumila standardized extract (SKF7®) reduces percentage of waist circumference and waist-to-height ratio in individuals with obesity.
Marantodes pumilum
abdominal obesity
body mass index
metabolic disorders
visceral fat
weight loss
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
revised:
13
07
2023
received:
21
02
2023
accepted:
14
07
2023
medline:
4
10
2023
pubmed:
8
8
2023
entrez:
8
8
2023
Statut:
ppublish
Résumé
Evidence from the literature points towards a viable choice of utilizing Labisia pumila to improve the metabolic profile in animal studies. To that end, this prospective study was designed to assess the health impact of the consumption of L. pumila standardized extract (SKF7®) on key parameters of obesity in humans such as body weight (BW), body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). A dose-ranging analysis using SKF7® was conducted through a randomized, double-blind, multicentre, placebo-controlled, phase 2 clinical trial involving individuals with obesity (N = 133) between January 2020 and April 2021. The potential percentage of change was assessed in relation to BW, BMI, WC and WHtR. Average treatment effect estimates (treatment group vs. placebo) show a statistically significant reduction in the percentage of change for BW (mean = -2.915; CI: -4.546, -1.285), BMI (-2.921; CI: -4.551, -1.291), WC (mean = -2.187; CI: -3.784, -0.589) and WHtR (mean = -2.294, CI: -3.908, -0.681) in the group with a total of 750 mg of SKF7® (p < .01). An incremental reduction in WC and WHtR was consistent with the gradual increase in the total daily concentration of SKF7® from 375 to 750 mg. WC and WHtR had higher effect size (f SKF7® is potentially a novel therapeutic treatment for obesity, reflected by reductions in BW, BMI, WC and WHtR. The use of SKF7® suggests a dose-dependent reduction in abdominal obesity, exemplified by a decline in WC and WHtR.
Banques de données
ClinicalTrials.gov
['NCT05851599']
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3298-3306Informations de copyright
© 2023 MEDIKA NATURA SDN. BHD. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Références
Ismail MN, Chee SS, Nawawi H, Yusoff K, Lim TO, James WPT. Obesity in Malaysia. Obes Rev. 2002;3(3):203-208.
Lee P. Malaysia is fattest country in South-East Asia. https://www.thestar.com.my/lifestyle/health/2018/08/14/fat-state-of-affairs/. Accessed January 25, 2023
Swarna NY. Addiction to sugar and its link to health morbidity: a primer for newer primary care and public health initiatives in Malaysia. J Prim Care Community Health. 2014;5(4):263-270.
The Straits Times. Malaysia studying whether to raise price ceiling of sugar. 2022 https://www.straitstimes.com/asia/se-asia/malaysia-studying-whether-to-raise-ceiling-price-of-sugar. Accessed January 25, 2023
Aris T, Mohd Yusoff MF, Abd Ghani AA, et al. National Health and Morbidity Survey 2015 (NHMS 2015). Kuala Lumpur; 2015.
Jo J, Gavrilove O, Pack S, et al. Hypertrophy and/or hyperplasia: dynamics of adipose tissue growth. PLoS Comput Biol. 2009;5(3):e1000324.
Wang X, Zhu H, Snieder H, et al. Obesity related methylation changes in DNA of peripheral blood leukocytes. BMC Med. 2010;8(87):1-8.
Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, Tcheroyan R, Mantzoros CS. Pharmacotherapy of obesity: an update on the available medications and drugs under investigation. EClinicalMedicine. 2023;58:101882.
Papadakis MA, Rabow MW, McPhee SJ. CURRENT Medical Diagnosis & Treatment 2018. 57th ed. McGraw Hill Education; 2018.
Bhardwaj M, Yadav P, Vashishth D, et al. A review on obesity management through natural compounds and a green nanomedicine-based approach. Molecules. 2021;26(11):3278.
Rakel DP, Minichiello V. Integrative Medicine. 5th ed. Elsevier; 2022.
Di Lorenzo C, Ceschi A, Kupferschmidt H, et al. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality. Br J Clin Pharmacol. 2015;79(4):578-592.
Fazliana M, Wan Nazaimoon WM, Gu HF, Östenson CG. Labisia pumila extract regulates body weight and adipokines in ovariectomized rats. Maturitas. 2009;62(1):91-97.
Eder K, Baffy N, Falus A, Fulop AK. The major inflammatory mediator interleukin-6 and obesity. Inflamm Res. 2009;58(11):727-1474.
Saeed AMA, Ghaffar G, Hamil MSR, et al. Weight reduction effect of standardized and liposome of Labisia pumila extracts with possible mechanisms of action. International Conference on Natural Product. Institute of Marrine Biotechnology and Malaysian Natural Product Society; 2016:230.
Katnapally P. Pharmacokinetic-pharmacodynamic study of Labisia pumila aqueous extract (SKF7®) following repeated oral dose administration in diet induced obese rats. Shameerpet 2022.
Parente EB, Mutter S, Harjutsalo V, Ahola AJ, Forsblom C, Groop PH. Waist-height ratio and waist are the best estimators of visceral fat in type 1 diabetes. Sci Rep. 2020;10:1-10.
Jayvikramjit Singh MS, Seman Z, et al. Waist to height ratio (WHtR): an anthropometric indicator for early detection of health risk for Malaysia's National Health and Morbidity Survey (NHMS). Int J Public Heal Clin Sci. 2020;7:76-89.
Swainson MG, Batterham AM, Tsakirides C, Rutherford ZH, Hind K. Prediction of whole-body fat percentage and visceral adipose tissue mass from five anthropometric variables. PLoS One. 2017;12(5):1-12.
Jelinek HF, Stranieri A, Yatsko A, Venkatraman S. Personalised measures of obesity using waist to height ratios from an Australian health screening program. Digit Heal. 2019;5:2055207619844362.
Ryan P. Random allocation of treatments in blocks. In: Newton HJ, ed. STATA Technical Bulletin Reprints. 7th ed. STATA Corporation; 1998:268-292.
U.S. Department of Health and Human Services Food and drug Administration Centre for Drug Evaluation and Research. Developing Products for Weight Management (Draft Guidance) 2007.
Cohen JE. Statistical Power Analysis for the Behavioral Sciences. Lawrence Erlbaum Associates Inc; 1988.
Kesztyüs D, Erhardt J, Schönsteiner D, Kesztyüs T. Therapeutic treatment for abdominal obesity in adults: a meta-analysis and systematic review of randomized controlled trials. Dtsch Arztebl Int. 2018;115(29-30):487-493.
Freedman DS, Ford ES. Are the recent secular increases in the waist circumference of adults independent of changes in BMI? Am J Clin Nutr. 2015;101(3):425-431.
Albrecht SS, Gordon-Larsen P, Stern D, Popkin BM. Is waist circumference per body mass index rising differentially across the United States, England, China and Mexico? Eur J Clin Nutr. 2015;69(12):1306-1312.
Stern D, Smith LP, Zhang B, Gordon-Larsen P, Popkin BM. Changes in waist circumference relative to body mass index in Chinese adults, 1993-2009. Int J Obes. 2014;38(12):1503-1510.
Aydin N, Topsever P, Kaya A, Karasakal M, Duman C, Dagar A. Orlistat, sibutramine, or combination therapy: which performs better on waist circumference in relation with body mass index in obese patients? Tohoku J Exp Med. 2004;202(3):173-180.
Khera R, Murad MH, Chandar AK, et al. Association of pharmacological treatments for obesity with weight loss and adverse events. JAMA. 2016;315(22):2424-2434.
Dludla PV, Nkambule BB, Jack B, et al. Inflammation and oxidative stress in an obese state and the protective effects of gallic acid. Nutrients. 2018;11(1):23.
Abdullah N, Chermahini SH, Suan CL, Sarmidi MR. Labisia pumila: a review on its traditional, phytochemical and biological uses. World Appl Sci J. 2013;27(10):1297-1306.
Zakaria AA, Noor MHM, Ahmad H, Hassim HA, Mazlan M, Latip MQA. A review on therapeutic effects of Labisia pumila on female reproductive diseases. Biomed Res Int. 2021;2021:9928199.
Fathilah SN, Mohamed N, Muhammad N, Mohamed IN, Soelaiman IN, Shuid AN. Labisia pumila regulates bone-related genes expressions in postmenopausal osteoporosis model. BMC Complement Altern Med. 2013;13(1):1.
Pandey A. Anti-obesity potential of gallic acid from Labisia pumila, through augmentation of adipokines in high fat diet induced obesity in C57BL/6 mice. Adv Res. 2014;2(10):556-570.
Abdul Kadir A, Nik Hussain NH, Wan Bebakar WM, et al. The effect of Labisia pumila var. alata on postmenopausal women: a pilot study. Evid Based Complement Alternat Med. 2012;2012:216525.
Teh BP, Ahmad N, Nurafnie E, et al. Herbal-based formulation containing Eurycoma longifolia and Labisia pumila aqueous extracts: safe for consumption? Pharmaceuticals. 2021;14(142):1-29.
George A, Wilson D, Abas A, Evans M. Safety and efficacy of a Labisia pumila var alata water extract on sexual well being and lipid profile of pre- and postmenopausal women: a randomized double-blind pilot study. African J Biotechnol. 2014;13(6):768-777.
Hussain NH, Kadir AA, Bebakar WM, Mohd DM, Shukor N, Kamaruddin NA. Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women. Int Med J. 2009;16(2):137-148.
Turck D, Bohn T, Castenmiller J, et al. Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to regulation (EU) 2015/2283. EFSA J. 2022;20(11):7611.
U.S. Food and Drug Administration. New Dietary Ingredient Notification for SKF7® Aqueous Ethanolic Standardized Extract of Labisia pumila var. alata. College Park 2022.