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Trials
Published in: Trials 1/2020

01-12-2020 | Prediabetes | Study protocol

Evaluation of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers in overweight or obese prediabetic patients: a study protocol for a randomized double-blind placebo-controlled phase 2 clinical trial

Authors: Majid Karandish, Hassan Mozaffari-khosravi, Seyed Mohammad Mohammadi, Maryam Azhdari, Bahman Cheraghian

Published in: Trials | Issue 1/2020

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Abstract

Background

The prevalence of prediabetes is increasing worldwide. Unfortunately, prediabetes is related to non-communicable diseases. A high risk of developing type 2 diabetes mellitus (T2DM) is reported in people with prediabetes. Curcumin, a polyphenol, might lead to its therapeutic role in obesity and some obesity-related metabolic diseases. Zinc is a trace element that plays a key role in the synthesis and action of insulin, carbohydrate metabolism, and decreasing inflammation. There has been no clinical trial of zinc and curcumin co-supplementation in patients with prediabetes. In previous studies, the single administration of zinc or curcumin has not been conducted on many of the studied markers in prediabetic patients.

Methods

The purpose of this randomized double-blind placebo-controlled clinical trial is to investigate the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers among 84 prediabetic patients with body mass index (BMI) between 25 and 35. Also, liver enzyme, serum zinc, urine zinc, blood pressure, anthropometric parameters, quality of life, adherence to co-supplementation, the side effects of co-supplementation, physical activity, and dietary intake will be assessed. Women or men (18–50 years old for men and 18 years to before menopause for women) will be followed for 3 months (90 days). This study will be conducted at Yazd Diabetes Research Clinic, Shahid Sadoughi University of Medical Sciences.

Discussion

A diet rich in antioxidants, polyphenols, and phytochemicals has been shown to have a beneficial role in prediabetes. According to the beneficial properties of curcumin or zinc and inadequate evidence, RCTs are needed to assess the effect of curcumin and zinc co-supplementation in native prediabetes patients. We hope the results of the present trial, negative or positive, fill this gap in the literature and facilitate the approach for a much larger, multi-center clinical trial. In conclusion, a synergic effect of co-supplementation along with a weight-loss diet may delay the progression to type 2 diabetes mellitus.

Trial registration

Iranian Registry of Clinical Trials (IRCT) IRCT201909020446​71N1. Registered on 11 October 2019
Appendix
Available only for authorised users
Literature
1.
Federation I. IDF diabetes atlas eighth edition. Brussels: International Diabetes Federation; 2017.
2.
American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical care in diabetes. Diabetes Care. 2018;41(Supplement 1):S13–27.CrossRef
3.
International Diabetes Federation. Chapter 1 - What is diabetes? In: IDF diabetes atlas. 8th ed; 2017.
4.
World Health Organization. Global report on diabetes. 2016.
5.
6.
Iraj B, Salami R, Feizi A, Amini M. The profile of hypertension and dyslipidemia in prediabetic subjects; results of the Isfahan Diabetes Prevention Program: a large population-based study. Adv Biomed Res. 2015;4:27.PubMedPubMedCentralCrossRef
7.
8.
9.
10.
Norris SL, Zhang X, Avenell A, Gregg E, Bowman B, Schmid CH, et al. Long-term effectiveness of weight-loss interventions in adults with pre-diabetes: a review. Am J Prev Med. 2005;28(1):126–39.PubMedCrossRef
11.
van der Schaft N, Schoufour JD, Nano J, Kiefte-de Jong JC, Muka T, Sijbrands EJG, et al. Dietary antioxidant capacity and risk of type 2 diabetes mellitus, prediabetes and insulin resistance: the Rotterdam Study. Eur J Epidemiol. 2019;34(9):853–61.PubMedPubMedCentralCrossRef
12.
Guasch-Ferre M, Merino J, Sun Q, Fito M, Salas-Salvado J. Dietary polyphenols, Mediterranean diet, prediabetes, and type 2 diabetes: a narrative review of the evidence. Oxidative Med Cell Longev. 2017;2017:6723931.CrossRef
13.
Abshirini M, Mahaki B, Bagheri F, Siassi F, Koohdani F, Sotoudeh G. Higher intake of phytochemical-rich foods is inversely related to prediabetes: a case-control study. Int J Prev Med. 2018;9:64.PubMedPubMedCentralCrossRef
14.
Benzie IF, Wachtel-Galor S. Herbal medicine: biomolecular and clinical aspects. 2nd ed. CRC Press/Taylor & Francis; 2011.
15.
Jurenka JS. Anti-inflammatory properties of curcumin, a major constituent of Curcuma longa: a review of preclinical and clinical research. Altern Med Rev. 2009;14(2):141–53.PubMed
16.
Visioli F, De La Lastra CA, Andres-Lacueva C, Aviram M, Calhau C, Cassano A, et al. Polyphenols and human health: a prospectus. Crit Rev Food Sci Nutr. 2011;51(6):524–46.PubMedCrossRef
17.
Lao CD, Ruffin MT, Normolle D, Heath DD, Murray SI, Bailey JM, et al. Dose escalation of a curcuminoid formulation. BMC Complement Altern Med. 2006;6:10.PubMedPubMedCentralCrossRef
18.
Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014;25(2):144–50.PubMedCrossRef
19.
20.
Azhdari M, Karandish M, Mansoori A. Metabolic benefits of curcumin supplementation in patients with metabolic syndrome: a systematic review and meta-analysis of randomized controlled trials. Phytother Res. 2019;33(5):1289–301.PubMedCrossRef
21.
Ahangarpour A, Sayahi M, Sayahi M. The antidiabetic and antioxidant properties of some phenolic phytochemicals: a review study. Diabetes Metab Syndr Clin Res Rev. 2019;13(1):854–7.CrossRef
22.
Singletary K. Turmeric: potential health benefits. Nutr Today. 2020;55(1):45–56.CrossRef
23.
Stefanska B. Curcumin ameliorates hepatic fibrosis in type 2 diabetes mellitus–insights into its mechanisms of action. Br J Pharmacol. 2012;166(8):2209–11.PubMedPubMedCentralCrossRef
24.
Shehzad A, Ha T, Subhan F, Lee YS. New mechanisms and the anti-inflammatory role of curcumin in obesity and obesity-related metabolic diseases. Eur J Nutr. 2011;50(3):151–61.PubMedCrossRef
25.
Lee KH, Chow YL, Sharmili V, Abas F, Alitheen NB, Shaari K, et al. BDMC33, a curcumin derivative suppresses inflammatory responses in macrophage-like cellular system: role of inhibition in NF-κB and MAPK signaling pathways. Int J Mol Sci. 2012;13(3):2985–3008.PubMedPubMedCentralCrossRef
26.
Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012;35(11):2121–7.PubMedPubMedCentralCrossRef
27.
Thota RN, Acharya SH, Garg ML. Curcumin and/or omega-3 polyunsaturated fatty acids supplementation reduces insulin resistance and blood lipids in individuals with high risk of type 2 diabetes: a randomised controlled trial. Lipids Health Dis. 2019;18(1):31.PubMedPubMedCentralCrossRef
28.
Cicero AFG, Fogacci F, Morbini M, Colletti A, Bove M, Veronesi M, et al. Nutraceutical effects on glucose and lipid metabolism in patients with impaired fasting glucose: a pilot, double-blind, placebo-controlled, randomized clinical trial on a combined product. High Blood Press Cardiovasc Prev. 2017;24(3):283–8.PubMedPubMedCentralCrossRef
29.
Yang YS, Su YF, Yang HW, Lee YH, Chou JI, Ueng KC. Lipid-lowering effects of curcumin in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled trial. Phytother Res. 2014;28(12):1770–7.PubMedCrossRef
30.
Amin F, Islam N, Anila N, Gilani A. Clinical efficacy of the co-administration of turmeric and black seeds (Kalongi) in metabolic syndrome–a double blind randomized controlled trial–TAK-MetS trial. Complement Ther Med. 2015;23(2):165–74.PubMedCrossRef
31.
Rahmani S, Asgary S, Askari G, Keshvari M, Hatamipour M, Feizi A, et al. Treatment of non-alcoholic fatty liver disease with curcumin: a randomized placebo-controlled trial. Phytother Res. 2016;30(9):1540–8.PubMedCrossRef
32.
Grant SJ, Chang DH-T, Liu J, Wong V, Kiat H, Bensoussan A. Chinese herbal medicine for impaired glucose tolerance: a randomized placebo controlled trial. BMC Complement Altern Med. 2013;13(1):104.PubMedPubMedCentralCrossRef
33.
Chasapis CT, Loutsidou AC, Spiliopoulou CA, Stefanidou ME. Zinc and human health: an update. Arch Toxicol. 2012;86(4):521–34.PubMedCrossRef
34.
35.
Jarosz M, Olbert M, Wyszogrodzka G, Mlyniec K, Librowski T. Antioxidant and anti-inflammatory effects of zinc. Zinc-dependent NF-κB signaling. Inflammopharmacology. 2017;25(1):11–24.PubMedPubMedCentralCrossRef
36.
Jayawardena R, Ranasinghe P, Galappatthy P, Malkanthi R, Constantine G, Katulanda P. Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr. 2012;4(1):13.PubMedPubMedCentralCrossRef
37.
Ranasinghe P, Wathurapatha W, Ishara M, Jayawardana R, Galappatthy P, Katulanda P, et al. Effects of zinc supplementation on serum lipids: a systematic review and meta-analysis. Nutr Metab. 2015;12(1):26.CrossRef
38.
Lukowiak B, Vandewalle B, Riachy R, Kerr-Conte J, Gmyr V, Belaich S, et al. Identification and purification of functional human β-cells by a new specific zinc-fluorescent probe. J Histochem Cytochem. 2001;49(4):519–28.PubMedCrossRef
39.
Islam MR, Attia J, Ali L, McEvoy M, Selim S, Sibbritt D, et al. Zinc supplementation for improving glucose handling in pre-diabetes: a double blind randomized placebo controlled pilot study. Diabetes Res Clin Pract. 2016;115:39–46.PubMedCrossRef
40.
Ranasinghe P, Wathurapatha WS, Galappatthy P, Katulanda P, Jayawardena R, Constantine GR. Zinc supplementation in prediabetes: a randomized double-blind placebo-controlled clinical trial. J Diabetes. 2018;10(5):386–97.PubMedCrossRef
41.
Kim H-N, Kim S-H, Eun Y-M, Song S-W. Effects of zinc, magnesium, and chromium supplementation on cardiometabolic risk in adults with metabolic syndrome: a double-blind, placebo-controlled randomised trial. J Trace Elem Med Biol. 2018;48:166–71.PubMedCrossRef
42.
Bogale A, Clarke SL, Fiddler J, Hambidge KM, Stoecker BJ. Zinc supplementation in a randomized controlled trial decreased ZIP4 and ZIP8 mRNA abundance in peripheral blood mononuclear cells of adult women. Nutr Metab Insights. 2015;8:7–14.PubMedPubMedCentralCrossRef
43.
Lotfi MH, Saadati H, Afzali M. Prevalence of diabetes in people aged ≥30 years: the results of screening program of Yazd Province, Iran, in 2012. J Res Health Sci. 2013;14(1):88–92.
44.
Pavlica S, Gaunitz F, Gebhardt R. Comparative in vitro toxicity of seven zinc-salts towards neuronal PC12 cells. Toxicol in Vitro. 2009;23(4):653–9.PubMedCrossRef
45.
Energy requirements of adults. In: FAO food and nutrition technical report series. Human energy requirements: report of a joint FAO/WHO/UNU expert consultation. Food Nutr Bull. 2005; 26(1):35–50.
46.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Diabetes Prevention Program Research Group, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.PubMedCrossRef
47.
Acceptable macronutrient distribution ranges. In: Otten J. Hellwig J. Meyer L. Dietary Reference Intakes. Washington, DC: National Academies Press; 2006. p. 70.
48.
49.
Pickering T, Hall J, Appel L, Falkner B, Graves J, Hill M, et al. Recommendations for blood pressure measurement in humans. A statement for professionals from the subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005;45:142–61.PubMedCrossRef
50.
Rifai N, Bachorik PS, Albers JJ. Lipids, lipoproteins and apolipoproteins. Tietz Textbook Clin Chem. 1999;3:809–61.
51.
Yang YJ, Kim MK, Hwang SH, Ahn Y, Shim JE, Kim DH. Relative validities of 3-day food records and the food frequency questionnaire. Nutr Res Pract. 2010;4(2):142–8.PubMedPubMedCentralCrossRef
52.
Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med. 2011;2(2):106.PubMedPubMedCentralCrossRef
53.
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.PubMedCrossRef
54.
Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005;14(3):875–82.PubMedCrossRef
55.
Osoba D. What has been learned from measuring health-related quality of life in clinical oncology. Eur J Cancer. 1999;35(11):1565–70.PubMedCrossRef
56.
Framework IC. The MOS 36-item short-form health survey (SF-36). Med Care. 1992;30(6):473–83.CrossRef
57.
Metadata
Title
Evaluation of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers in overweight or obese prediabetic patients: a study protocol for a randomized double-blind placebo-controlled phase 2 clinical trial
Authors
Majid Karandish
Hassan Mozaffari-khosravi
Seyed Mohammad Mohammadi
Maryam Azhdari
Bahman Cheraghian
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04923-w

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