Back to resultsThe Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hesperidin
hesperidin and flaxseed
flaxseed
control
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age of 18 to 70 years
- having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD
Exclusion Criteria:
- pregnancy or lactation
- history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
- Following a program to lose weight in recent 3 mo
Sites / Locations
- National Nutrition and Food Technology Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
hesperidin and flaxseed
control
flaxseed
hesperidin
Arm Description
1000 mg hesperidin as two capsules and 30 grams flaxseed
no supplementation
30 grams flaxseed
1000 mg hesperidin as two capsules
Outcomes
Primary Outcome Measures
Metabolic syndrome: Number of participants with treated metabolic syndrome
Number of participants with treated metabolic syndrome
Secondary Outcome Measures
Full Information
NCT ID
NCT03734835
First Posted
November 6, 2018
Last Updated
November 7, 2018
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT03734835
Brief Title
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
Official Title
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic 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
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hesperidin and flaxseed
Arm Type
Active Comparator
Arm Description
1000 mg hesperidin as two capsules and 30 grams flaxseed
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
no supplementation
Arm Title
flaxseed
Arm Type
Active Comparator
Arm Description
30 grams flaxseed
Arm Title
hesperidin
Arm Type
Active Comparator
Arm Description
1000 mg hesperidin as two capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
hesperidin
Intervention Description
1000 mg hesperidin as two capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
hesperidin and flaxseed
Intervention Description
1000 mg hesperidin as two capsules and 30 grams flaxseed
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed
Intervention Description
30 grams flaxseed
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no supplementation
Primary Outcome Measure Information:
Title
Metabolic syndrome: Number of participants with treated metabolic syndrome
Description
Number of participants with treated metabolic syndrome
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 to 70 years
having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD
Exclusion Criteria:
pregnancy or lactation
history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
Following a program to lose weight in recent 3 mo
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
azita Hekmatdoost, MD.PhD
Phone
+982122357484
Email
a_hekmat2000@yahoo.com
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
State/Province
Iran (the Islamic Republic Of)
ZIP/Postal Code
1981619573
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azits Hekmatdoost, MD,PhD
Phone
+982122357484
12. IPD Sharing Statement
Learn more about this trial
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
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