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

• ClinicalTrials.gov Identifier: NCT01360957
• Recruitment Status: Withdrawn
• First Posted: May 26, 2011
• Last Update Posted: November 18, 2015
• Sponsor: Shahid Beheshti University of Medical Sciences
• Information provided by: Shahid Beheshti University of Medical Sciences

Study Description

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

Condition or disease	Intervention/treatment	Phase
Obesity	Dietary Supplement: Black cumin water extract as a traditional medicine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Completion Date: June 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. BP (blood pressure) [ Time Frame: 0 and12 weeks ]
   Change from Baseline in Systolic Blood Pressure at 12 weeks
2. HR (heart rate) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in heart rate at 12 weeks
3. Body water (percentage) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in body water at 12 weeks
4. Fat free mass (percentage) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in fat free mass at 12 weeks
5. Fat mass (percentage) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in fat mass at 12 weeks
6. Bone mass [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in bone mass at 12 weeks
7. BMR (basic metabolic rate) [ Time Frame: 0 and12 weeks ]
   Change from Baseline in BMR at 12 weeks
8. AMR (active metabolic rate) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in AMR at 12 weeks

Secondary Outcome Measures :

1. BMI (body mass index) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in BMI at 12 weeks
2. WHR (waist to hip ratio) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in WHR at 12 weeks
3. MUAC (mid upper arm circumference) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in MUAC at 12 weeks
4. Wrist circumference [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in wrist circumference at 12 weeks
5. Changes in appetite as measured by a 10-point visual analog scale (VAS) [ Time Frame: 0 and 12 weeks ]
   Change from Baseline in VAS at 12 weeks

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Being Obese

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01360957
• Other Study ID Numbers: 23911
• First Posted: May 26, 2011
• Last Update Posted: November 18, 2015
• Last Verified: February 2011

Keywords provided by Shahid Beheshti University of Medical Sciences:

Obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight