Diabetes MellitusNCT03776448
The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.
A study testing Sativa Nigra oil Softgels and Activated Charcoal Softgels in people with Diabetes Mellitus, run by Sulaiman AlRajhi Colleges at 1 site in Saudi Arabia.
Trial summary
Diabetes mellitus is a growing global concern with significant health and financial burdens. The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes prevalence. Strict blood glucose control is an important measure in the treatment of diabetes and prevention of its complications. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sativa Nigra oil Softgels and Activated Charcoal Softgels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2019to Feb 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-60
- Regular Student or Faculty in Sulaiman Alrajhi Colleges
- Consenting for intervention and follow up
Who cannot join
- Type I diabetes or Insulin Therapy
- Significant chronic medical illness
- Current use of long-term prescription drugs
- Current use of black seed oil
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Sulaiman AlRajhi Colleges
Al Bukairiyah, Al-Qassim Region, 51941, PO Box 777
Nazmus Saquib, Phd, 966 533445899, a.saquib@sr.edu.sa
Nazmus Saquib, Phd
About this study
Official title: 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
Diabetes mellitus is a growing global concern with significant health and financial burdens. The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes prevalence. Strict blood glucose control is an important measure in the treatment of diabetes and prevention of its complications. The scientific community has recently shown a profound interest in the area of complementary and alternative medicine where a ton of research is being conducted. The primary focus of this field of research is subjecting many of the medicinal plants used in herbalism to the scientific methodology of testing. In order for these plants to be implemented in treatment protocols, their effect must be clearly proven and documented scientifically. This study aims to investigate the effect of daily consumption of black seed oil on the blood sugar levels of healthy adults.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Sativa Nigra oil Softgels, Activated Charcoal Softgels
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sativa Nigra oil SoftgelsDietary supplement
Also called Blackseed oil softgels
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. .
Activated Charcoal SoftgelsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sativa Nigra oil arm | Experimental | 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. Receives: Dietary Supplement: Sativa Nigra oil Softgels |
| The charcoal arm | Placebo comparator | 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. Receives: Dietary Supplement: Activated Charcoal Softgels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting venous blood glucose
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.
Measured: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Secondary outcomes (2)
Blood pressure
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
Measured: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Gastrointestinal symptoms
The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.
Measured: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulaiman AlRajhi Colleges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazmus Saquib, Phd, Principal investigator, SRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776448
- Sponsor's protocol ID
- SulimanAC-BlackseedOil
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03776448
- Acronym / sponsor ID
- SulimanAC-BlackseedOil
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sulaiman AlRajhi CollegesUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 14 Dec 2018 (actual)
- 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.
Diabetes mellitus is a growing global concern with significant health and financial burdens. The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes prevalence. Strict blood glucose control is an important measure in the treatment of diabetes and prevention of its complications. The scientific community has recently shown a profound interest in the area of complementary and alternative medicine where a ton of research is being conducted. The primary focus of this field of research is subjecting many of the medicinal plants used in herbalism to the scientific methodology of testing. In order for these plants to be implemented in treatment protocols, their effect must be clearly proven and documented scientifically. This study aims to investigate the effect of daily consumption of black seed oil on the blood sugar levels of healthy adults.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativa Nigra oil arm | Experimental | Dietary Supplement: Sativa Nigra oil SoftgelsA 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. |
| The charcoal arm | Placebo comparator | Dietary Supplement: Activated Charcoal SoftgelsSubject 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18-60
- Regular Student or Faculty in Sulaiman Alrajhi Colleges
- Consenting for intervention and follow up
Key exclusion criteria (5 listed)
- Type I diabetes or Insulin Therapy
- Significant chronic medical illness
- Current use of long-term prescription drugs
- Current use of black seed oil
- Pregnancy
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 |
|---|---|---|
| Sativa Nigra oil SoftgelsAlso: Blackseed oil softgelsNigella 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. . | Dietary supplement | Sativa Nigra oil arm |
| Activated Charcoal SoftgelsThis 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. | Dietary supplement | The charcoal arm |
Primary outcome
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.
2 secondary outcomes
Blood pressure
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Nazmus Saquib, Phd principal investigator
SRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sativa Nigra oil Softgels and Activated Charcoal Softgels in people with Diabetes Mellitus, run by Sulaiman AlRajhi Colleges at 1 site in Saudi Arabia.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazmus Saquib, Phd (699 533445899, a.saquib@sr.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting venous blood glucose (time frame: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention). 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 14 Dec 2018.