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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01360957
Recruitment Status : Withdrawn (Mahnaz Kazemipoor has not handed over human subject review board approval letter to her colleague.)
First Posted : May 26, 2011
Last Update Posted : November 18, 2015
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE May 24, 2011
First Posted Date  ICMJE May 26, 2011
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01360957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 17, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2011)
100
Actual Study Completion Date  ICMJE June 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Being Obese

Exclusion Criteria:

  • Having heart disease or renal disease
  • using drugs influencing metabolism and appetite
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Iran, Islamic Republic of
 
Administrative Information
NCT Number  ICMJE NCT01360957
Other Study ID Numbers  ICMJE 23911
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP