Effects of Chromium Picolinate on Glycemic Index,Lipid Profile ،Gene Expression of Inflammatory Biomarkers and DNA damage in Metabolic Syndrome Patients
Determining the effect of trivalent chromium picolinate supplementation on glycemic indexes , lipid profiles, gene expression of some inflammatory mediators and DNA damage in metabolic syndrome patients
Design
Randomized controlled clinical trial with two arm parallel group, patients(n=48) will be randomly divided into equal two groups of intervention or placebo using computer software Random-Number Generator
Settings and conduct
Sisakht City Adult Cohort Study. Anthropometric and biochemical indicators will be measured before and after 12 weeks of intervention. The patients themselves, the principal investigator, the laboratory technician and statistical analyzer will not be aware of the grouping of participants and only a trusted health expert will be aware. The tablets received by the two groups will be the same in terms of packaging, smell, color and appearance.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having the metabolic syndrome
Exclusion criteria:
- take any multivitamins or dietary supplements or medications, Pregnancy and lactation, uncontrolled blood pressure, uncontrolled blood sugar, heart arrhythmias and chronic obstructive pulmonary disease, stroke or any other disease that requires medical treatment
Intervention groups
Intervention in the first group: 400µg of trivalent chromium picolinate tablets (21 st CENTURY, US company)
Intervention in the first group: matched placebo tablets chromium picolinate
Main outcome variables
Glycemic index, Lipid Profile ،Gene Expression of Inflammatory Biomarkers and DNA damage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048757N1
Registration date:2020-10-18, 1399/07/27
Registration timing:prospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Behrooz Ebrahimzadehkoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6078
Email address
ebrahimzadeh1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Chromium Picolinate on Glycemic Index,Lipid Profile ،Gene Expression of Inflammatory Biomarkers and DNA damage in Metabolic Syndrome Patients
Public title
effects of chromium picolinate in metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Metabolic syndrome characterized by"at least three of the five conditions: - waist circumference ≥94 cm - systolic blood pressure and diastolic greater than or equal to 130 and 85 mm Hg respectively or blood pressure lowering medication use - Fasting Blood Sugar≥ 100 mg / dl or hypoglycemic drugs use - Blood triglycerides ≥150 mg / dl or lipid-lowering drugs use - HDL<50mg/dl in women and less than 40 mg/ dl in Men"
Exclusion criteria:
take any multivitamins or dietary supplements or medications
Pregnancy or lactation
uncontrolled hypertension or hyperglycemia
chronic obstructive pulmonary disease
heart arrhythmias
stroke
any other disease that requires medical treatment
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, from registered information of people in the Sisakht cityAdult Cohort Center,all eligible persons will be listed and numbered .Then,48 patients will be randomly selected using Random Numbers Generator software. In the next step, based on above mentioned software as a random sequencing tool, patients will be divided into two intervention groups A ( intervention) and B ( placebo).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients participating in the study, laboratory technician , statistical analyst and researcher will not be aware from patient grouping until the end of the study and only a trusted health expert who has no involvement in the
process of study will be informed. The tablets received by both groups will be the same in terms of color, smell and appearance . The label of the boxes containing the tablets will be removed and only will be marked with a special code .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional research ethics committe of school of public health-Shahid sdoughi university of medic
Street address
N.887, Shohadaye Gomnam Blvd, Alem Sq. Pardis oloompezeshki- school of public health