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

This study has been withdrawn prior to enrollment.
(Mahnaz Kazemipoor has not handed over human subject review board approval letter to her colleague.)
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01360957
First received: May 24, 2011
Last updated: June 13, 2011
Last verified: February 2011
  Purpose

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 Intervention
Obesity
Dietary Supplement: Black cumin water extract as a traditional medicine

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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • BP (blood pressure) [ Time Frame: 0 and12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in Systolic Blood Pressure at 12 weeks

  • HR (heart rate) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in heart rate at 12 weeks

  • Body water (percentage) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in body water at 12 weeks

  • Fat free mass (percentage) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in fat free mass at 12 weeks

  • Fat mass (percentage) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in fat mass at 12 weeks

  • Bone mass [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in bone mass at 12 weeks

  • BMR (basic metabolic rate) [ Time Frame: 0 and12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in BMR at 12 weeks

  • AMR (active metabolic rate) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in AMR at 12 weeks


Secondary Outcome Measures:
  • BMI (body mass index) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: Yes ]
    Change from Baseline in BMI at 12 weeks

  • WHR (waist to hip ratio) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in WHR at 12 weeks

  • MUAC (mid upper arm circumference) [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in MUAC at 12 weeks

  • Wrist circumference [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from Baseline in VAS at 12 weeks


Estimated Enrollment: 100
Study Completion Date: June 2011
Arms Assigned Interventions
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

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

Ages Eligible for Study:   16 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01360957     History of Changes
Other Study ID Numbers: 23911
Study First Received: May 24, 2011
Last Updated: June 13, 2011
Health Authority: Ethics Committee: Iran

Keywords provided by Shahid Beheshti Medical University:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014