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Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women

NCT ID: NCT01360957

Last Updated: 2015-11-18

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this clinical trial is to study the therapeutic effect of black cumin water extract (Nigella sativa L.) on obesity and overweight

Detailed Description

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The worldwide prevalence of obesity has reached epidemic proportions mostly in low-income and transitional than in industrialized countries. Changes in dietary habits and sedentary lifestyles are known to be associated with changes in health and increased prevalence of chronic diseases in the population. The need to promote healthy nutrition for the population must be pursued vigorously, as the escalation of nutrition-related chronic degenerative diseases - once an urban phenomenon - has now spread to the rural population at an alarming rate. During the past decades efficacious strategies have been developed for prevention of these diseases. These strategies involve general lifestyle changes, which include, healthy diet, optimal weight, physical activity, moderate or no alcohol consumption, control of diabetes mellitus and in particular, treatment of obesity. Although the global market for satiety, fat burning and other weight management remedies has been grown, the awareness of the benefits of weight management ingredients is neither sufficient nor clearly perceived by consumer. Subsequently, the opportunities for scientifically-substantiated weight management ingredients regarding the natural and herbal dietary pattern are impressive.

The seed of Nigella sativa (black cumin) is one of the most common traditional herbs for weight loss in the Middle East which is usually used as a spice as well as traditional medicine to treat a variety of health conditions especially inflammatory diseases and obesity.

Furthermore, many of the components present in black cumin including polyphenols have been attributed to have anti-inflammatory and anti-obesity effect which further supports our hypothesis.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Water flavored placebo

to be given orally in a dosage of 30 ml trice daily for 60 days

Group Type PLACEBO_COMPARATOR

Black cumin water extract as a traditional medicine

Intervention Type DIETARY_SUPPLEMENT

to be given orally in a dosage of 30 ml trice daily for 60 days

Black cumin water extract as a traditional medicine

Black cumin water extract as a traditional medicine to be given orally in a dosage of 30 ml trice daily for 60 days

Group Type EXPERIMENTAL

Black cumin water extract as a traditional medicine

Intervention Type DIETARY_SUPPLEMENT

to be given orally in a dosage of 30 ml trice daily for 60 days

Interventions

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Black cumin water extract as a traditional medicine

to be given orally in a dosage of 30 ml trice daily for 60 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Being Obese

Exclusion Criteria

* Having heart disease or renal disease
* using drugs influencing metabolism and appetite
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shahid Beheshti University of Medical Sciences

Other Identifiers

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23911

Identifier Type: -

Identifier Source: org_study_id