The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
crocin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2
Exclusion Criteria:
pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease
Sites / Locations
- National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
crocin
Arm Description
Outcomes
Primary Outcome Measures
type 2 diabetes
number of participants with normal plasma glucose
Secondary Outcome Measures
Full Information
NCT ID
NCT04163757
First Posted
November 12, 2019
Last Updated
November 14, 2019
Sponsor
National Nutrition and Food Technology Institute
Collaborators
Vahideh Behrouz, Ali Dastkhosh
1. Study Identification
Unique Protocol Identification Number
NCT04163757
Brief Title
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
Official Title
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
Collaborators
Vahideh Behrouz, Ali Dastkhosh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
crocin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
crocin
Intervention Description
2 tablets crocin per day
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
2 tablets placebo per day
Primary Outcome Measure Information:
Title
type 2 diabetes
Description
number of participants with normal plasma glucose
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:
Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2
Exclusion Criteria:
pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32670418
Citation
Behrouz V, Dastkhosh A, Hedayati M, Sedaghat M, Sharafkhah M, Sohrab G. The effect of crocin supplementation on glycemic control, insulin resistance and active AMPK levels in patients with type 2 diabetes: a pilot study. Diabetol Metab Syndr. 2020 Jul 9;12:59. doi: 10.1186/s13098-020-00568-6. eCollection 2020.
Results Reference
derived
Learn more about this trial
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
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