The objective of this randomized double-blind placebo controlled trial is to assess the effect of Cuminum cyminum L. supplementation on components, inflammatory and oxidative stress indices in patients with metabolic syndrome. Subjects will be recruited to the study, according to inclusion criteria and exclusion criteria.Subjects including 44 individuals from both sexes will be randomly divided into two intervention and control groups.Subjects in intervention and control group will receive 75 mg three times a day of cumin or placebo respectively for 8 weeks. The assignment of groups will cover from the investigators and the subjects. Fasting blood samples, blood pressure and anthropometric measurements, 3 dietary records for each person will be performed at the beginning and end of the study. The levels of markers of inflammatory and oxidative, blood sugar, lipid profile and insulin in the fasting blood samples will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701193140N20
Registration date:2017-03-29, 1396/01/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-29, 1396/01/09
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cuminum cyminum L. supplementation on components, inflammatory and oxidative stress indices in patients with metabolic syndrome.
Public title
The effect of Cumin pearl on treatment of metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate; age 18-60 years; affected by metabolic syndrome with three out of five criteria: waist circumference>91 cm in women and >89 cm for men; serum triglyceride≥150 mg/dL; fasting serum glucose≥100mg/dL; serum HDL-C<40 mg/dL in men and <50 mg/dl in women; systolic blood pressure≥130mmhg and/or diastolic blood pressure≥ 85mmhg. Exclusion criteria: pregnancy or lactation; usage of insulin; renal or liver failure; thyroid disorder; following a specific diet; alcohol intake; smoking; being menopause; usage of nutritional supplement in the past 3 month of the study; taking of corticosteroids or immunosuppressive drugs ....
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1168
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.9
ICD-10 code description
metabolic disorders not specified
Primary outcomes
1
Description
Anthropometric idices
Timepoint
Baseline and end of study
Method of measurement
Stadiometer, Scale, Tape
2
Description
Lipid profile
Timepoint
Baseline and end of study
Method of measurement
Biochemical Analysis
Secondary outcomes
1
Description
Insulin
Timepoint
Baseline and end of study
Method of measurement
ELISA
2
Description
Energy intake
Timepoint
Baseline and end of study
Method of measurement
Three day dietary record questionnare
3
Description
Macronutrient
Timepoint
Baseline and end of study
Method of measurement
Three day dietary record questionnare
4
Description
Micronutrient
Timepoint
Baseline and end of study
Method of measurement
Three day dietary record questionnare
5
Description
Hemoglobin A1c
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
6
Description
Fasting Blood Sugar
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
7
Description
Insulin resistance
Timepoint
Baseline and end of study
Method of measurement
Formula
8
Description
MDA
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
9
Description
Total anti oxidant
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
10
Description
Catalase
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
11
Description
Superoxide dismutase
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
12
Description
High sensitive C-Reactive Protein
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry
13
Description
Tumor Necrosis Factor
Timepoint
Baseline and end of study
Method of measurement
ELISA
14
Description
Systolic and diastolic blood pressure
Timepoint
Baseline and end of study
Method of measurement
Digital monometer
Intervention groups
1
Description
Intervention group: Cumin essential oil capsule (75 mg), 3 times a day for 8 weeks
Category
Prevention
2
Description
Contol group: Placebo capsule (75mg), 3 times a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Salahadin Ayubi Hospital, Kurdistan University of Medical Science