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

NCT ID: NCT03734835

Last Updated: 2018-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-03-01

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hesperidin and flaxseed

1000 mg hesperidin as two capsules and 30 grams flaxseed

Group Type ACTIVE_COMPARATOR

hesperidin and flaxseed

Intervention Type DIETARY_SUPPLEMENT

1000 mg hesperidin as two capsules and 30 grams flaxseed

control

no supplementation

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

no supplementation

flaxseed

30 grams flaxseed

Group Type ACTIVE_COMPARATOR

flaxseed

Intervention Type DIETARY_SUPPLEMENT

30 grams flaxseed

hesperidin

1000 mg hesperidin as two capsules

Group Type ACTIVE_COMPARATOR

hesperidin

Intervention Type DIETARY_SUPPLEMENT

1000 mg hesperidin as two capsules

Interventions

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hesperidin

1000 mg hesperidin as two capsules

Intervention Type DIETARY_SUPPLEMENT

hesperidin and flaxseed

1000 mg hesperidin as two capsules and 30 grams flaxseed

Intervention Type DIETARY_SUPPLEMENT

flaxseed

30 grams flaxseed

Intervention Type DIETARY_SUPPLEMENT

control

no supplementation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Nutrition and Food Technology Research Institute

Tehran, Iran (the Islamic Republic Of), Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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azita Hekmatdoost, MD.PhD

Role: CONTACT

+982122357484

Facility Contacts

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Azits Hekmatdoost, MD,PhD

Role: primary

+982122357484

Other Identifiers

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13678

Identifier Type: -

Identifier Source: org_study_id

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