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

NCT03734835 | Unknown

• 1 other identifier: 13678
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Metabolic syndrome: Number of participants with treated metabolic syndrome

  Number of participants with treated metabolic syndrome

  12 weeks

Study Arms (4)

hesperidin and flaxseed

ACTIVE COMPARATOR

1000 mg hesperidin as two capsules and 30 grams flaxseed

Dietary Supplement: hesperidin and flaxseed

control

PLACEBO COMPARATOR

no supplementation

Other: control

flaxseed

ACTIVE COMPARATOR

30 grams flaxseed

Dietary Supplement: flaxseed

hesperidin

ACTIVE COMPARATOR

1000 mg hesperidin as two capsules

Dietary Supplement: hesperidin

Interventions

hesperidin DIETARY_SUPPLEMENT

1000 mg hesperidin as two capsules

hesperidin

hesperidin and flaxseed DIETARY_SUPPLEMENT

1000 mg hesperidin as two capsules and 30 grams flaxseed

hesperidin and flaxseed

flaxseed DIETARY_SUPPLEMENT

30 grams flaxseed

flaxseed

control OTHER

no supplementation

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 to 70 years
• having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD

You may not qualify if:

• pregnancy or lactation
• history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
• Following a program to lose weight in recent 3 mo

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran (the Islamic Republic Of), 1981619573, Iran

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Hesperidin; Linseed Oil

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

azita Hekmatdoost, MD.PhD

CONTACT

+982122357484; a_hekmat2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: April 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

IR (1)