Evidence map›Paper›PMID 33256795›Full record

ArticleTrials2020

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.

Majid Karandish, Hassan Mozaffari-Khosravi, Seyed Mohammad Mohammadi, Maryam Azhdari, Bahman Cheraghian

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Nanocurcumin combined with insulin alleviates diabetic kidney disease through P38/P53 signaling axis.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
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  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Majid KarandishNutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Hassan Mozaffari-KhosraviDepartment of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Seyed Mohammad MohammadiSchool of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Maryam AzhdariStudent Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. azhdari_mar@yahoo.com.ORCID http://orcid.org/0000-0003-2110-9817
Bahman CheraghianDepartment of Biostatistics and Epidemiology, School of Health Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Ahvaz Jundishapur University of Medical Sciences · IRShahid Sadoughi University of Medical Sciences and Health Services · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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 registrationIranian Registry of Clinical Trials (IRCT) IRCT20190902044671N1 . Registered on 11 October 2019.

Indexed as

CurcuminDiabetes Mellitus, Type 2Prediabetic StateAdolescentAdultAntioxidantsBiomarkersBlood GlucoseClinical Trials, Phase II as TopicDietary SupplementsDouble-Blind MethodFemaleHumansIranLipidsMaleAntioxidantsBiomarkersBlood GlucoseCurcuminLipidsZincAntioxidant biomarkersCurcuminGlycemic measurementInflammatory biomarkersLipid profilePrediabetesRandomized controlled trialZinc

Identifiers

PMID33256795
PMCPMC7708225
OpenAlexW3109861550

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.