- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776448
The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.
The Effect of 2 Grams Daily Supplementation of Thymoquinone -Containing Sativa Nigra Oil on Blood Glucose Levels of Adults: A Placebo-controlled Double-blinded Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Question and Objectives:
Research question: Will daily consumption of 2g of N. sativa extract oil improve (decrease) fasting blood glucose levels of adults?
Research Objectives:
Primary: To conduct a feasibility study investigating the effect of daily consumption of 2g of N. sativa extract oil on the fasting blood glucose levels of adults.
Secondary: To investigate the effect of daily consumption of 2g of N. sativa oil extract on blood pressure.
Secondary: To investigate the feasibility of regular black seed oil intake by means of gastrointestinal symptoms questionnaire
Trial Design:
Design: This is a placebo-controlled double-blinded randomized controlled trial with two parallel groups.
Allocation: The randomization will substantially reduce the risk of selection bias and confounding factors. Simple randomization will be used in this study. This randomization will insure a balanced 1:1 allocation ratio at the end of sample recruitment. A computer program will be used to generate a set of random numbers, an allocation sequence. Each number assigns the participant either to the intervention or the control group. However, this information will only be revealed after a sealed opaque file is opened at the time of recruitment.
Framework: Exploratory study to gather preliminary information on the intervention and the feasibility of its use in blood glucose control.
Study Setting:
This study will be conducted in the internal clinics of Sulaiman Al Rajhi Colleges in Qassim region, Kingdom of Saudi Arabia.
Participants Timeline:
The primary outcome (Fasting blood glucose, FBG) will be assessed three times during the study period. FBG measurement moments for each participant are at 0, 2, and 4 weeks from the time of randomization. The rationale behind spacing measuring moments two weekly is to allow a sufficient response time for FBG levels to be interpretable. Secondary outcomes will be assessed weekly totaling five assessments at 0, 1, 2, 3 and 4 weeks from the time of randomization. The participant will have to visit the College internal clinics at his or her respective measurement points. The participant will be reminded the night before to remain fasting for at least 6 hours before the visit. At each visit, the participant will initially answer a set of questions to assess the degree of compliance and adherence. He or she then will be asked to report any possible side effects and will be allowed a time to fill in the questionnaires and express any concerns he or she might have. Next, blood pressure will be measured. Finally, a venous blood sample will be taken to measure the fasting blood glucose.
Recruitment:
The participants in this study are going to be recruited form Sulaiman Al Rajhi Colleges, Al-Qassim, Kingdom of Saudi Arabia. Multiple channels will be used to recruit subjects including but not limited to: invitation posters/flyers, E-mails and social media. Prospective participants will be subjected to our inclusion/exclusion criteria to determine their eligibility and finalize their recruitment and randomization. Each participant will have to provide a written informed consent in order be enrolled.
- Data Collection:
Primary outcome: Trained personnel will be responsible for obtaining venous blood samples from all subjects in a controlled and private environment. Each sample will be labeled with the participant's unique identification code and sent immediately to a cooperating external lab equipped with advanced and accurate devices.
Secondary outcomes: Each participant will have his or her blood pressure measured privately in the internal clinic by trained personnel using a standardized sphygmomanometer. The side effects of the intervention will be assessed by means of a questionnaire specifically developed for the purpose. The use of a standardized questionnaire is not necessary since the data is not intended to diagnose or categorize any particular health condition.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nazmus Saquib, Phd
- Phone Number: 699 533445899
- Email: a.saquib@sr.edu.sa
Study Contact Backup
- Name: Ahmed Abduljalil
- Phone Number: 699 595449479
- Email: 13110033@srcolleges.org
Study Locations
-
-
Qassim
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Al Bukairiyah, Qassim, Saudi Arabia, 51941, PO Box 777
- Sulaiman AlRajhi Colleges
-
Contact:
- Nazmus Saquib, Phd
- Phone Number: 966 533445899
- Email: a.saquib@sr.edu.sa
-
Principal Investigator:
- Nazmus Saquib, Phd
-
Sub-Investigator:
- Ahmed Abduljalil
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 18-60
- Regular Student or Faculty in Sulaiman Alrajhi Colleges
- Consenting for intervention and follow up
Exclusion Criteria:
- Type I diabetes or Insulin Therapy
- Significant chronic medical illness
- Current use of long-term prescription drugs
- Current use of black seed oil
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sativa Nigra oil arm
A total of 15 subjects randomly allocated to the treatment arm will receive 2000mg a day of 'Sativa Nigra oil' softgels for 30 consecutive days.
The total daily dose is divided in 4 doses taken 6 hourly (each softgel contains 500mg).
This supplement is manufactured by [Bioextract Ltd, Sri Lanka] and is available commercially.
|
Nigella sativa, a flowering plant native to southwest Asia, is considered one of the most important healing medicinal plants in Islamic culture.
The use of its richly colored black seeds has been recommended in the prophetic medicine.
It's also known by various other names amongst different cultures.
Importantly, its seed is known in Arabic as 'habat al Baraka' which translates literally to 'the seed of blessing'.The active ingredient is believed to be thymoquinone richly present in the oil extract of its seeds.
Apart from mild occasional gastrointestinal disturbance, black seed oil has no side effects and is considered very safe. .
Other Names:
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Placebo Comparator: The charcoal arm
Subject randomly allocated to the control arm will receive 1040mg a day of activated charcoal softgels for 30 consecutive days.
The total daily dosage is divided in 4 doses taken 6 hourly (each softgel contains 260mg).
This supplement is manufactured by [Arkopharma Pharmaceutical Laboratories] and is available commercially.
|
This supplement is manufactured by [Arkopharma Pharmaceutical Laboratories] and is available commercially.
The use of activated charcoal softgels as a placebo is documented in several other clinical trials.
The single most relevant characteristic of charcoal is its minimal if any gastrointestinal absorption.
As a result, it does not undergo any metabolism and is excreted completely in feces.
This makes charcoal an attractive placebo choice for small trials or when manufacturing a specific placebo is not feasible.
Charcoal softgels are black in color and resemble black seed oil softgels to a great extent.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting venous blood glucose
Time Frame: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
The change from baseline in fasting venous blood glucose after 1 month of intervention.
The participant-level analysis is change from baseline at 1 month and the method of aggregation for each study group is the mean.
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The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
the change from baseline in mean seated blood pressure after 1 month of intervention.
The participant-level analysis is change from baseline at 1 month and the method of aggregation for each study group is the mean
|
This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
Gastrointestinal symptoms
Time Frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.
|
This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nazmus Saquib, Phd, SRC
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SulimanAC-BlackseedOil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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