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

Obesity Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01360957
• Other study ID #: 23911
• Status: Withdrawn
• Phase: N/A
• First received: May 24, 2011
• Last updated: November 17, 2015
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee: Iran
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Being Obese

Exclusion Criteria:

• Having heart disease or renal disease

• using drugs influencing metabolism and appetite

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BP (blood pressure)	Change from Baseline in Systolic Blood Pressure at 12 weeks	0 and12 weeks	No
Primary	HR (heart rate)	Change from Baseline in heart rate at 12 weeks	0 and 12 weeks	No
Primary	Body water (percentage)	Change from Baseline in body water at 12 weeks	0 and 12 weeks	No
Primary	Fat free mass (percentage)	Change from Baseline in fat free mass at 12 weeks	0 and 12 weeks	No
Primary	Fat mass (percentage)	Change from Baseline in fat mass at 12 weeks	0 and 12 weeks	No
Primary	Bone mass	Change from Baseline in bone mass at 12 weeks	0 and 12 weeks	No
Primary	BMR (basic metabolic rate)	Change from Baseline in BMR at 12 weeks	0 and12 weeks	No
Primary	AMR (active metabolic rate)	Change from Baseline in AMR at 12 weeks	0 and 12 weeks	No
Secondary	BMI (body mass index)	Change from Baseline in BMI at 12 weeks	0 and 12 weeks	Yes
Secondary	WHR (waist to hip ratio)	Change from Baseline in WHR at 12 weeks	0 and 12 weeks	No
Secondary	MUAC (mid upper arm circumference)	Change from Baseline in MUAC at 12 weeks	0 and 12 weeks	No
Secondary	Wrist circumference	Change from Baseline in wrist circumference at 12 weeks	0 and 12 weeks	No
Secondary	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	No