ObesityNCT01360957
Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
A study testing Black cumin water extract as a traditional medicine in people with Obesity, run by Shahid Beheshti University of Medical Sciences.
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 Read more about this study
- Who is it for?
- Ages 16 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Black cumin water extract as a traditional medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being Obese
Who cannot join
- Having heart disease or renal disease
- using drugs influencing metabolism and appetite
About this study
The purpose of this clinical trial is to study the therapeutic effect of black cumin water extract (Nigella sativa L.) on obesity and overweight
Read the 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.
- Conditions
- Obesity
- Being tested
- Black cumin water extract as a traditional medicine
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black cumin water extract as a traditional medicineDietary supplement
to be given orally in a dosage of 30 ml trice daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Water flavored placebo | Placebo comparator | to be given orally in a dosage of 30 ml trice daily for 60 days Receives: Dietary Supplement: Black cumin water extract as a traditional medicine |
| Black cumin water extract as a traditional medicine | Experimental | Black cumin water extract as a traditional medicine to be given orally in a dosage of 30 ml trice daily for 60 days Receives: Dietary Supplement: Black cumin water extract as a traditional medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP (blood pressure)
Change from Baseline in Systolic Blood Pressure at 12 weeks
Measured: 0 and12 weeks
HR (heart rate)
Change from Baseline in heart rate at 12 weeks
Measured: 0 and 12 weeks
Body water (percentage)
Change from Baseline in body water at 12 weeks
Measured: 0 and 12 weeks
Fat free mass (percentage)
Change from Baseline in fat free mass at 12 weeks
Measured: 0 and 12 weeks
Fat mass (percentage)
Change from Baseline in fat mass at 12 weeks
Measured: 0 and 12 weeks
Bone mass
Change from Baseline in bone mass at 12 weeks
Measured: 0 and 12 weeks
BMR (basic metabolic rate)
Change from Baseline in BMR at 12 weeks
Measured: 0 and12 weeks
AMR (active metabolic rate)
Change from Baseline in AMR at 12 weeks
Measured: 0 and 12 weeks
Secondary outcomes (5)
BMI (body mass index)
Change from Baseline in BMI at 12 weeks
Measured: 0 and 12 weeks
WHR (waist to hip ratio)
Change from Baseline in WHR at 12 weeks
Measured: 0 and 12 weeks
MUAC (mid upper arm circumference)
Change from Baseline in MUAC at 12 weeks
Measured: 0 and 12 weeks
Wrist circumference
Change from Baseline in wrist circumference at 12 weeks
Measured: 0 and 12 weeks
Changes in appetite as measured by a 10-point visual analog scale (VAS)
Change from Baseline in VAS at 12 weeks
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study completionJun 2011
Why it stopped: Mahnaz Kazemipoor has not handed over human subject review board approval letter to her colleague.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360957
- Sponsor's protocol ID
- 23911
- Status last verified
- Feb 2011
- First submitted
- 24 May 2011
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
- ClinicalTrials.gov ID
- NCT01360957
- Acronym / sponsor ID
- 23911
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Mahnaz Kazemipoor has not handed over human subject review board approval letter to her colleague.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study completion
- Jun 2011 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water flavored placebo | Placebo comparator | Dietary Supplement: Black cumin water extract as a traditional medicineto be given orally in a dosage of 30 ml trice daily for 60 days |
| Black cumin water extract as a traditional medicine | Experimental | Dietary Supplement: Black cumin water extract as a traditional medicineBlack cumin water extract as a traditional medicine to be given orally in a dosage of 30 ml trice daily for 60 days |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Being Obese
Key exclusion criteria (2 listed)
- Having heart disease or renal disease
- using drugs influencing metabolism and appetite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black cumin water extract as a traditional medicineto be given orally in a dosage of 30 ml trice daily for 60 days | Dietary supplement | Black cumin water extract as a traditional medicine, Water flavored placebo |
Primary outcome
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
5 secondary outcomes
BMI (body mass index)
Time frame: 0 and 12 weeks
WHR (waist to hip ratio)
Time frame: 0 and 12 weeks
MUAC (mid upper arm circumference)
Time frame: 0 and 12 weeks
Wrist circumference
Time frame: 0 and 12 weeks
Changes in appetite as measured by a 10-point visual analog scale (VAS)
Time frame: 0 and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Black cumin water extract as a traditional medicine in people with Obesity, run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BP (blood pressure) (time frame: 0 and12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.