ObesityNCT01833377
Effect of Consumption of Caraway on Treatment of Obesity
A study testing caraway sample in people with Obesity and Overweight, run by University of Malaya.
Trial summary
This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- caraway sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2012
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight and obese women (BMI> 25)
- aged 20-55 years old
- healthy subjects
Who cannot join
- Pregnant and lactating women
- Thyroid disease
- type I or II diabetes mellitus
- hypertension (systolic BP 140 and/or diastolic BP 90)
- endocrine dysfunction
- impaired liver function
Show all 20Show fewer
- chronic renal disease
- cardiovascular disease
- primary dyslipidemia
- myopathy
- patients using drugs which affect on metabolism or appetite
- a maintained weight loss in the preceding 3 months
- meals not eaten at regular intervals
- participation in another investigation study within the past 30 days
- a history of alcohol or drug abuse within the past year
- smoking
- a history of sleep disorders
- clinical depression or other psychiatric conditions
- abnormal obese
- allergy or sensitivity to any of the 'active' or 'placebo' product ingredients
About this study
Official title: Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women
This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy.
Read the detailed description
A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.
the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).
- Conditions
- Obesity, Overweight
- Being tested
- caraway sample, placebo
- Keywords
- obesity, overweight, BMI
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caraway sampleDietary supplement
Also called caraway water extract product
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| caraway sample | Experimental | caraway sample Receives: Dietary Supplement: caraway sample |
| Placebo | Active comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index
The changes in BMI from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Secondary outcomes (10)
change in all blood parameters
The changes in all blood parameters from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
The changes in systolic and diastolic blood pressure and pulse rate from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in body weight
The changes in body weight from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
The changes in anthropometric indices including waist, hip, thigh and mid-upper arm circumference from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in appetite
The changes in appetite from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
The changes in body composition from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in body weight (kg)
The changes in body weight from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in basic and active metabolic rate
The changes in BMR and AMR from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in food intake
Change in food intake
The changes in food intake (macro and micro nutrient intake) from baseline at 12 weeks are measured.
Measured: Baseline and 12 weeks
Change in urine specific gravity
The changes in urine specific gravity from baseline at 12 weeks are measured.
Measured: Baseline 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 posted16 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- che wan jasimah mohamed radzi, PhD, Study chair, University of MalayaMajid Hajifaraji, PhD, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833377
- Sponsor's protocol ID
- NCT12345678
- Status last verified
- Apr 2013
- First submitted
- 26 Mar 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kazemipoor M, Rezaeian M, Kazemipoor M, Hamzah S, Shandilya SK. Computational Intelligence Techniques for Assessing Anthropometric Indices Changes in Female Athletes. Curr Med Imaging. 2020;16(4):288-295. doi: 10.2174/1573405614666180905111814.
PubMed 32410532Kazemipoor M, Radzi CW, Hajifaraji M, Haerian BS, Mosaddegh MH, Cordell GA. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:928582. doi: 10.1155/2013/928582. Epub 2013 Nov 10.
PubMed 24319489
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women
- ClinicalTrials.gov ID
- NCT01833377
- Acronym / sponsor ID
- NCT12345678
- Conditions
- Obesity, Overweight
- Keywords
- obesity, overweight, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Apr 2013 (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.
This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy.
Detailed description
A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.
the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).
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 |
|---|---|---|
| caraway sample | Experimental | Dietary Supplement: caraway samplecaraway sample |
| Placebo | Active comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- overweight and obese women (BMI> 25)
- aged 20-55 years old
- healthy subjects
Key exclusion criteria (20 listed)
- Pregnant and lactating women
- Thyroid disease
- type I or II diabetes mellitus
- hypertension (systolic BP 140 and/or diastolic BP 90)
- endocrine dysfunction
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 |
|---|---|---|
| caraway sampleAlso: caraway water extract product | Dietary supplement | caraway sample |
| placebo | Dietary supplement | Placebo |
Primary outcome
Change in body mass index
Time frame: Baseline and 12 weeks
The changes in BMI from baseline at 12 weeks are measured.
10 secondary outcomes
change in all blood parameters
Time frame: Baseline and 12 weeks
Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
Time frame: Baseline and 12 weeks
Change in body weight
Time frame: Baseline and 12 weeks
Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
Time frame: Baseline and 12 weeks
Change in appetite
Time frame: Baseline and 12 weeks
Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
Time frame: Baseline and 12 weeks
Change in body weight (kg)
Time frame: Baseline and 12 weeks
Change in basic and active metabolic rate
Time frame: Baseline and 12 weeks
Change in food intake
Time frame: Baseline and 12 weeks
Change in urine specific gravity
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Derived from this study: PubMed 32410532Kazemipoor M, Rezaeian M, Kazemipoor M, Hamzah S, Shandilya SK. Computational Intelligence Techniques for Assessing Anthropometric Indices Changes in Female Athletes. Curr Med Imaging. 2020;16(4):288-295. doi: 10.2174/1573405614666180905111814.
- Derived from this study: PubMed 24319489Kazemipoor M, Radzi CW, Hajifaraji M, Haerian BS, Mosaddegh MH, Cordell GA. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:928582. doi: 10.1155/2013/928582. Epub 2013 Nov 10.
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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.
che wan jasimah mohamed radzi, PhD study chair
University of Malaya
Majid Hajifaraji, PhD study director
Shahid Beheshti University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing caraway sample in people with Obesity and Overweight, run by University of Malaya.
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 3 inclusion and 20 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: finished, as of the sponsor's last update on 16 Apr 2013. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in body mass index (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833377, which also lists 2 linked publications.
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 16 Apr 2013.