PMID- 33256795 OWN - NLM STAT- MEDLINE DCOM- 20210617 LR - 20231112 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 21 IP - 1 DP - 2020 Nov 30 TI - 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. PG - 991 LID - 10.1186/s13063-020-04923-w [doi] LID - 991 AB - 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) IRCT20190902044671N1 . Registered on 11 October 2019. FAU - Karandish, Majid AU - Karandish M AD - Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. FAU - Mozaffari-Khosravi, Hassan AU - Mozaffari-Khosravi H AD - Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. FAU - Mohammadi, Seyed Mohammad AU - Mohammadi SM AD - School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. FAU - Azhdari, Maryam AU - Azhdari M AUID- ORCID: 0000-0003-2110-9817 AD - Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. azhdari_mar@yahoo.com. AD - Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. azhdari_mar@yahoo.com. FAU - Cheraghian, Bahman AU - Cheraghian B AD - Department of Biostatistics and Epidemiology, School of Health Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. LA - eng PT - Clinical Trial Protocol PT - Journal Article DEP - 20201130 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Antioxidants) RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Lipids) RN - IT942ZTH98 (Curcumin) RN - J41CSQ7QDS (Zinc) SB - IM MH - Adolescent MH - Adult MH - Antioxidants/adverse effects MH - Biomarkers MH - Blood Glucose MH - Clinical Trials, Phase II as Topic MH - *Curcumin/adverse effects MH - *Diabetes Mellitus, Type 2/diagnosis/drug therapy MH - Dietary Supplements MH - Double-Blind Method MH - Female MH - Humans MH - Iran MH - Lipids MH - Male MH - Middle Aged MH - Obesity/diagnosis/drug therapy MH - Overweight/diagnosis/drug therapy MH - *Prediabetic State/diagnosis/drug therapy MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Young Adult MH - Zinc PMC - PMC7708225 OTO - NOTNLM OT - Antioxidant biomarkers OT - Curcumin OT - Glycemic measurement OT - Inflammatory biomarkers OT - Lipid profile OT - Prediabetes OT - Randomized controlled trial OT - Zinc COIS- The authors declare that they have no conflict of interest. EDAT- 2020/12/02 06:00 MHDA- 2021/06/22 06:00 PMCR- 2020/11/30 CRDT- 2020/12/01 05:37 PHST- 2020/09/01 00:00 [received] PHST- 2020/11/19 00:00 [accepted] PHST- 2020/12/01 05:37 [entrez] PHST- 2020/12/02 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/11/30 00:00 [pmc-release] AID - 10.1186/s13063-020-04923-w [pii] AID - 4923 [pii] AID - 10.1186/s13063-020-04923-w [doi] PST - epublish SO - Trials. 2020 Nov 30;21(1):991. doi: 10.1186/s13063-020-04923-w.