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NCT03734835 Clinical Trial

The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03734835
Other study ID # 13678
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date March 1, 2019

Study information
Verified date November 2018
Source National Nutrition and Food Technology Institute
Contact azita Hekmatdoost, MD.PhD
Phone +982122357484
Email a_hekmat2000@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• hesperidin
1000 mg hesperidin as two capsules
• hesperidin and flaxseed
1000 mg hesperidin as two capsules and 30 grams flaxseed
• flaxseed
30 grams flaxseed
Other:
• control
no supplementation

Locations
Country Name City State
Iran, Islamic Republic of National Nutrition and Food Technology Research Institute Tehran Iran (the Islamic Republic Of)

Sponsors (1)
Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic syndrome: Number of participants with treated metabolic syndrome Number of participants with treated metabolic syndrome 12 weeks
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