A scientifically validated combination of garcinol, curcuminoids, and piperine for mild to moderate nonalcoholic steatohepatitis patients-results from a randomized, double-blind, placebo-controlled study

被引:2
作者
Majeed, Muhammed [1 ,2 ]
Nagabhushanam, Kalyanam [2 ]
Noureddin, Mazen [3 ]
Paulose, Shaji [1 ]
Barik, Chinmoy [4 ]
Saklecha, Santosh [5 ]
Mundkur, Lakshmi [1 ]
机构
[1] Sami Sabinsa Grp Ltd, Bangalore, Karnataka, India
[2] Sabinsa Corp, East Windsor, NJ USA
[3] Houston Res Inst, Houston Liver Inst, Houston, TX USA
[4] JNM Hosp, Kalyani, West Bengal, India
[5] Santosh Hosp, Bengaluru, Karnataka, India
来源
FRONTIERS IN NUTRITION | 2023年 / 10卷
关键词
nonalcoholic steatohepatitis; curcuminoids; garcinol; piperine; Fibroscan; liver stiffness; FAST score; FATTY LIVER-DISEASE; SUPPLEMENTATION; FIBROSIS; BIOAVAILABILITY; RESVERATROL; ADIPONECTIN; STEATOSIS; DIAGNOSIS; ENZYMES; NAFLD;
D O I
10.3389/fnut.2023.1201186
中图分类号
R15 [营养卫生、食品卫生]; TS201 [基础科学];
学科分类号
100403 ;
摘要
Background Garcinol is a naturally occurring compound from the fruit rind of the Garcinia indica, with antioxidant, anti-inflammatory, and anticancer properties. Curcuminoids are the active molecule from the rhizome of Curcuma longa, studied extensively for its health benefits as an anti-inflammatory and antioxidant activities. Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic steatohepatitis characterized by liver fat and inflammation.Objective To evaluate the clinical efficacy and safety of Garcinol, Curcuminoids and piperine (GCP) combination in patients with mild to moderate NASH in a randomized, double-blind, placebo-controlled study.Methods The patients received one tablet (450 mg) of GCP containing garcinol-50 mg, curcuminoids -250 mg and piperine 5 mg or a placebo (450 mg of microcrystalline cellulose) twice daily for 90 days. Changes in circulating aspartate aminotransferase (AST), alanine transaminase (ALT) levels, liver stiffness measurement (LSM), and controlled attenuation parameter (CAP) using Fibroscan were compared from baseline to day 90. Anthropometric parameters, serum levels of lipids, Interleukin (IL-6), hsCRP, and adiponectin were estimated. Safety was evaluated by laboratory parameters and by monitoring adverse events.Results Seventy-two patients were randomized and 63 (GCP = 32, Placebo = 31) completed the study. The mean age of the patients was 48.3 +/- 8.7 years (36 males and 27 females). The mean reduction in AST (U/L) was 9.53 in GCP and 3.16 in placebo (p < 0.001) and that of ALT (U/L) was 13.47 in GCP and 7.43 in Placebo (p = 0.002). The liver stiffness and CAP scores showed a better reduction in GCP (0.56 kPa and 12.38 db/m) compared to placebo (0.064 kPa and 10.42 db/m) p < 0.05. Consequently, the noninvasive Fibroscan-AST (FAST) score reduction was also found to be significant in GCP compared to placebo. Additionally, body weight, lipid levels, hsCRP, and IL-6 in serum decreased, while adiponectin levels increased in GCP-supplemented participants compared to placebo. The combination of garcinol and curcuminoids was well tolerated with no significant changes in hematological and clinical laboratory parameters during the 90-day supplementation.Conclusion Our results suggest that GCP could be a possible supplement for the management of NASH. Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2019/11/022147.Conclusion Our results suggest that GCP could be a possible supplement for the management of NASH. Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2019/11/022147.
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页数:14
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共 63 条
  • [21] Diagnostic Accuracy and Reliability of Ultrasonography for the Detection of Fatty Liver: A Meta-Analysis
    Hernaez, Ruben
    Lazo, Mariana
    Bonekamp, Susanne
    Kamel, Ihab
    Brancati, Frederick L.
    Guallar, Eliseo
    Clark, Jeanne M.
    [J]. HEPATOLOGY, 2011, 54 (03) : 1082 - 1090
  • [22] Hung WL, 2014, FOOD FUNCT, V5, P2883, DOI [10.1039/C4FO00342J, 10.1039/c4fo00342j]
  • [23] Jin ZH, 2018, CHIN J NAT MEDICINES, V16, P143, DOI 10.1016/S1875-5364(18)30041-4
  • [24] Enhancing the bioavailability of resveratrol by combining it with piperine
    Johnson, Jeremy J.
    Nihal, Minakshi
    Siddiqui, Imtiaz A.
    Scarlett, Cameron O.
    Bailey, Howard H.
    Mukhtar, Hasan
    Ahmad, Nihal
    [J]. MOLECULAR NUTRITION & FOOD RESEARCH, 2011, 55 (08) : 1169 - 1176
  • [25] Curcumin and Curcuma longa L. extract ameliorate lipid accumulation through the regulation of the endoplasmic reticulum redox and ER stress
    Lee, Hwa-Young
    Kim, Seung-Wook
    Lee, Geum-Hwa
    Choi, Min-Kyung
    Chung, Han-Wool
    Lee, Yong-Chul
    Kim, Hyung-Ryong
    Kwon, Ho Jeong
    Chae, Han-Jung
    [J]. SCIENTIFIC REPORTS, 2017, 7
  • [26] Lee PS, 2019, MOL NUTR FOOD RES, V63, DOI [10.1002/mnfr.201800390, 10.1002/mnfr.201970003]
  • [27] The role of the gut microbiota in NAFLD
    Leung, Christopher
    Rivera, Leni
    Furness, John B.
    Angus, Peter W.
    [J]. NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY, 2016, 13 (07) : 412 - 425
  • [28] Novel Combinatorial Regimen of Garcinol and Curcuminoids for Non-alcoholic Steatohepatitis (NASH) in Mice
    Majeed, Muhammed
    Majeed, Shaheen
    Nagabhushanam, Kalyanam
    Lawrence, Lincy
    Mundkur, Lakshmi
    [J]. SCIENTIFIC REPORTS, 2020, 10 (01)
  • [29] Garcinia indica extract standardized for 20% Garcinol reduces adipogenesis and high fat diet-induced obesity in mice by alleviating endoplasmic reticulum stress
    Majeed, Muhammed
    Majeed, Shaheen
    Nagabhushanam, Kalyanam
    Lawrence, Lincy
    Mundkur, Lakshmi
    [J]. JOURNAL OF FUNCTIONAL FOODS, 2020, 67
  • [30] Safety profile of 40% Garcinol from Garcinia indica in experimental rodents
    Majeed, Muhammed
    Bani, Sarang
    Bhat, Beena
    Pandey, Anjali
    Mundkur, Lakshmi
    Neupane, Prakriti
    [J]. TOXICOLOGY REPORTS, 2018, 5 : 750 - 758