Protocol summary
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Study aim
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The determining of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
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Design
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a double-blind randomized controlled trial/ factorial design/
4 parallel groups: (N=21)
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Settings and conduct
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84 patients referring to Yazd Diabetes Specialty Clinic who meet the inclusion criteria will be randomly divided into 4 groups by random sampling. General Characterization and the assessment of anthropometric, diet, Weight loss, physical activity, and biochemistry will conduct for each patient. After 3 months of supplementation, the above assessment will be re-evaluated.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Both genders age: 18-50 years, prediabetic patients, BMI=25-35 No use of blood glucose-lowering drugs, written informed consent from patients
Exclusion criteria:
Having a history of gestational diabetes,- Pregnancy or lactation in women, Use of multivitamin-mineral supplements from three months before and during the intervention, a history of weight loss surgery in the last year, weight loss plan in the last 3 months, Sensitivity to supplementation or non-compliance during the intervention, Simultaneously participate in another project, Unwillingness to continue cooperation
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Intervention groups
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pre-diabetes patients
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Main outcome variables
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insulin, fasting glucose, HbA1c, insulin resistance, insulin sensitivity, beta-cell function, serum triglyceride, serum total cholesterol, serum LDL-C, HDL-C, ALT, AST, TAC, MDA, serum zinc, IL-1B, CRP, hs-CRP,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190902044671N1
Registration date:
2019-10-11, 1398/07/19
Registration timing:
prospective
Last update:
2020-11-13, 1399/08/23
Update count:
1
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Registration date
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2019-10-11, 1398/07/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-11, 1398/08/20
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Expected recruitment end date
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2020-05-21, 1399/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
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Public title
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The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
both genders
age: 18-50 years (for women 18 years before menopause
individuals with IFG =100-125 (mg/dL), IGT =140-199(mg/dL), or/and HbA1c=% 6.4 -5.7 ,
individuals with BMI=25-35
No use of blood glucose-lowering drugs such as Metformin or Glucophage
individuals with written informed consent from patients
Exclusion criteria:
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to prevent selection bias from occurring after randomization, the concealment allocation method will be used to assign binary codes to each individual.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Before starting the study, a person other than the researchers will code the packages including two cans according to the number of participants in the study to keep the researcher informed about the type of pills received by each group. Each individual is delivered a pack including two cans. On each can, how to use the pills will be explained. Package 1 will contain (can1: placebo for curcumin supplement (bb), and can 2: zinc supplement (AA)); package 2 will contain (can1: placebo for zinc supplement (aa), and can 2: curcumin supplement (BB)); Package 3 will contain (can 1: zinc supplementation (AA) and can 2: curcumin supplementation (BB)), package 4 will contain (can 1: placebo for curcumin supplement (aa), and can 2: placebo for zinc supplement (bb)).
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Placebo
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Used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-05, 1398/07/13
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Ethics committee reference number
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IR.AJUMS.REC.1398.504
Health conditions studied
1
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Description of health condition studied
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Pre-diabetic
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ICD-10 code
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R-73.0
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ICD-10 code description
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Abnormal glucose tolerance test
Primary outcomes
1
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Description
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Fasting blood glucose
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
2
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Description
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serum insulin
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
3
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Description
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hemoglobin A1c
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
4
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Description
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serum triglyceride
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
5
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Description
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insulin resistance
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Timepoint
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at the beginning and end of study
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Method of measurement
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insulin resistance formula (HOMA-IR)
6
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Description
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insulin sensitivity
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Timepoint
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at the beginning and end of study
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Method of measurement
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insulin sensitivity formula
7
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Description
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beta-cell function
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Timepoint
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at the beginning and end of study
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Method of measurement
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formula
8
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Description
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total cholesterol
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
9
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Description
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serum Low Density lipoprotein -Cholesterol (LDL-C)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
10
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Description
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serum Low Density lipoprotein -Cholesterol (HDL-C )
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
11
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Description
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Malondialdehyde (MDA)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
12
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Description
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Total Antioxidant Capacity (TAC)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
13
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Description
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serum zinc
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
14
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Description
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interleukin 1-B (IL-1B )
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
15
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Description
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C- Reaction Protein (CRP)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
16
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Description
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High sensitivity C- Reaction Protein(hs-CRP)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
Secondary outcomes
1
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Description
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Aspartate Transaminase (AST)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
2
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Description
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Alanine Transaminase (ALT)
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Timepoint
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at the beginning and end of study
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Method of measurement
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serum sample
3
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Description
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weight
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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seca scales
4
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Description
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height
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Timepoint
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at the beginning
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Method of measurement
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stadiometer
5
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Description
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waist circumference
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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tape
6
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Description
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hip circumference
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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tape
7
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Description
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blood pressure
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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Korotkoff sound technique with a calibrated mercury sphygmomanometer
8
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Description
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Body composition (fat mass (FM), free fat mass (FFM), muscle mass (MM))
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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bioelectrical impedance analysis (BIA) method by a Body Composition Analyzer (InBody 270, Seoul, South Korea)
9
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Description
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Dietary intake (energy, carbohydrate, fat, protein)
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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using Nutritionist IV software
10
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Description
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Physical activity
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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Short form of the International Physical Activity Questionnaire (IPAQ-SF)
11
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Description
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Health-related quality of life
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Timepoint
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at the beginning,and end of the study
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Method of measurement
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SF-36 questionnaire
Intervention groups
1
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Description
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Intervention group: curcumin supplement
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Category
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Treatment - Drugs
2
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Description
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Intervention group: zinc supplement
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Category
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Treatment - Drugs
3
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Description
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Intervention group: curcumin supplement+zinc supplement
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Category
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Treatment - Drugs
4
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Description
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Control group: placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran,
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Proportion provided by this source
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60
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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40
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all data is related to primary and secondary outcome, will be reported.
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When the data will become available and for how long
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After the manuscript publication.
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To whom data/document is available
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After publication, it will be possible for everyone.
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Under which criteria data/document could be used
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Using the documentation with citation
1- To conduct similar and extensive research
2- To use the method of a project
3. To write systematic Review and meta-analysis articles
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From where data/document is obtainable
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1- Refer to the Library of Ahvaz Jundishapur University of Medical Sciences
1-Refer to the Library of Yazd University of Medical Sciences
3- Email to Maryam Azdari: azhdari_mar@yahoo.com)
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What processes are involved for a request to access data/document
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Everyone can use the data Referring to the library of the above-mentioned universities or by the emailing, for received data by email, it will be necessary to explain the reason for the using the data completely and clearly. He/she will be received within a maximum of one week.
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Comments
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