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

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Black cumin water extract as a traditional medicine

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Being Obese

Exclusion Criteria:

• Having heart disease or renal disease
• using drugs influencing metabolism and appetite

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water flavored placebo; to be given orally in a dosage of 30 ml trice daily for 60 days	Dietary supplement: Black cumin water extract as a traditional medicine; to be given orally in a dosage of 30 ml trice daily for 60 days
Experimental: 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	Dietary supplement: Black cumin water extract as a traditional medicine; to be given orally in a dosage of 30 ml trice daily for 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP (blood pressure)	Change from Baseline in Systolic Blood Pressure at 12 weeks	0 and12 weeks
HR (heart rate)	Change from Baseline in heart rate at 12 weeks	0 and 12 weeks
Body water (percentage)	Change from Baseline in body water at 12 weeks	0 and 12 weeks
Fat free mass (percentage)	Change from Baseline in fat free mass at 12 weeks	0 and 12 weeks
Fat mass (percentage)	Change from Baseline in fat mass at 12 weeks	0 and 12 weeks
Bone mass	Change from Baseline in bone mass at 12 weeks	0 and 12 weeks
BMR (basic metabolic rate)	Change from Baseline in BMR at 12 weeks	0 and12 weeks
AMR (active metabolic rate)	Change from Baseline in AMR at 12 weeks	0 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (body mass index)	Change from Baseline in BMI at 12 weeks	0 and 12 weeks
WHR (waist to hip ratio)	Change from Baseline in WHR at 12 weeks	0 and 12 weeks
MUAC (mid upper arm circumference)	Change from Baseline in MUAC at 12 weeks	0 and 12 weeks
Wrist circumference	Change from Baseline in wrist circumference at 12 weeks	0 and 12 weeks
Changes in appetite as measured by a 10-point visual analog scale (VAS)	Change from Baseline in VAS at 12 weeks	0 and 12 weeks

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 23911