Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes
Primary Purpose
Non Insulin Dependent Diabetes
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
curcumin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Insulin Dependent Diabetes
Eligibility Criteria
Inclusion Criteria:
- Tendency to participate
- Age range of 40-65
- Suffering from diabetes type 2 ( between 1 to 10 yeares)
- BMI 18/5-30
- Patients with diabetes who administer oral hypoglycemic agents and do not use
Exclusion Criteria:
- patients with liver diseases
- patients with kidney diseases
- patients with inflammatory diseases
- patients with liver diseases
- Administering herbal agents
- Administering multivitamins and minerals in past 3 months
Sites / Locations
- NNFTRI clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intervention
placebo
Arm Description
500 mg curcumin capsule
500 mg placebo
Outcomes
Primary Outcome Measures
Triglyceride
Secondary Outcome Measures
C-Reactive Protein
Full Information
NCT ID
NCT02529969
First Posted
August 19, 2015
Last Updated
August 19, 2015
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT02529969
Brief Title
Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes
Official Title
Curcumin Supplementation and Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
5. Study Description
Brief Summary
Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Insulin Dependent Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
500 mg curcumin capsule
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
500 mg placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Triglyceride
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
C-Reactive Protein
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tendency to participate
Age range of 40-65
Suffering from diabetes type 2 ( between 1 to 10 yeares)
BMI 18/5-30
Patients with diabetes who administer oral hypoglycemic agents and do not use
Exclusion Criteria:
patients with liver diseases
patients with kidney diseases
patients with inflammatory diseases
patients with liver diseases
Administering herbal agents
Administering multivitamins and minerals in past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Golbon Sohrab
Phone
+98-21-22077424
Email
golbonsohrab@yahoo.com
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Golbon Sohrab, PhD
Phone
9123069156
Email
golbonsohrab@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes
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