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

Study Overview
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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

Intervention / Treatment
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* Dietary Supplement: Black cumin water extract as a traditional medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being Obese Exclusion Criteria: Having heart disease or renal disease using drugs influencing metabolism and appetite

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water flavored placebo<br>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<br>* to be given orally in a dosage of 30 ml trice daily for 60 days<br>|
| Experimental: Black cumin water extract as a traditional medicine<br>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<br>* to be given orally in a dosage of 30 ml trice daily for 60 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity