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

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: hesperidin and flaxseed; Dietary Supplement: flaxseed; Other: control; Dietary Supplement: hesperidin

• Registration Number: NCT03734835
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-07
• Last Update Submitted: 2018-11-07
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hesperidin and flaxseed	hesperidin and flaxseed	1000 mg hesperidin as two capsules and 30 grams flaxseed
flaxseed	flaxseed	30 grams flaxseed
control	control	no supplementation
hesperidin	hesperidin	1000 mg hesperidin as two capsules

Primary Outcome Measures

Name	Time	Method
Metabolic syndrome: Number of participants with treated metabolic syndrome	12 weeks	Number of participants with treated metabolic syndrome

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of