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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: May 24, 2011
• First Posted Date: May 26, 2011
• Last Update Posted Date: November 18, 2015
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: May 24, 2011)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01360957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 24, 2011)

• BMI (body mass index) [ Time Frame: 0 and 12 weeks ]
  Change from Baseline in BMI at 12 weeks
• WHR (waist to hip ratio) [ Time Frame: 0 and 12 weeks ]
  Change from Baseline in WHR at 12 weeks
• MUAC (mid upper arm circumference) [ Time Frame: 0 and 12 weeks ]
  Change from Baseline in MUAC at 12 weeks
• Wrist circumference [ Time Frame: 0 and 12 weeks ]
  Change from Baseline in wrist circumference at 12 weeks
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
• Official Title: Not Provided
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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

Study Arms

• Placebo Comparator: Water flavored placebo
  to be given orally in a dosage of 30 ml trice daily for 60 days
  Intervention: Dietary Supplement: Black cumin water extract as a traditional medicine
• 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
  Intervention: Dietary Supplement: Black cumin water extract as a traditional medicine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 17, 2015): 0
• Original Estimated Enrollment (submitted: May 24, 2011): 100
• Actual Study Completion Date: June 2011
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Being Obese

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 16 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT01360957
• Other Study ID Numbers: 23911
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shahid Beheshti University of Medical Sciences
• Study Sponsor: Shahid Beheshti University of Medical Sciences
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shahid Beheshti University of Medical Sciences
• Verification Date: February 2011