Clinical trial NCT01360957: Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Being Obese

Exclusion Criteria:

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

Primary outcomes:
measure: BP (blood pressure)
timeFrame: 0 and12 weeks
measure: HR (heart rate)
timeFrame: 0 and 12 weeks
measure: Body water (percentage)
timeFrame: 0 and 12 weeks
measure: Fat free mass (percentage)
timeFrame: 0 and 12 weeks
measure: Fat mass (percentage)
timeFrame: 0 and 12 weeks
measure: Bone mass
timeFrame: 0 and 12 weeks
measure: BMR (basic metabolic rate)
timeFrame: 0 and12 weeks
measure: AMR (active metabolic rate)
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: BMI (body mass index)
timeFrame: 0 and 12 weeks
measure: WHR (waist to hip ratio)
timeFrame: 0 and 12 weeks
measure: MUAC (mid upper arm circumference)
timeFrame: 0 and 12 weeks
measure: Wrist circumference
timeFrame: 0 and 12 weeks
measure: Changes in appetite as measured by a 10-point visual analog scale (VAS)
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
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