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The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.

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ClinicalTrials.gov Identifier: NCT03776448
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sulaiman AlRajhi Colleges

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Dietary Supplement: Sativa Nigra oil Softgels Dietary Supplement: Activated Charcoal Softgels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Both participants and researchers involved directly in collecting data (ex. Measuring blood pressure or interviewing subjects) will be unaware of the allocation status and thus blinded. However, statistical analysts and those who will provide the participants with the intervention/placebo will be aware of the allocation status. All interventions (black seed oil and charcoal softgels) will be supplemented in neutral identical containers. Each participant will receive a container labeled with his or her specific identification code and containing the intervention for the arm to which he or she has been allocated.
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.
Dietary Supplement: Sativa Nigra 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. .
Other Name: Blackseed oil softgels

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.
Dietary Supplement: Activated Charcoal Softgels
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776448


Contacts
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Contact: Nazmus Saquib, Phd 699 533445899 a.saquib@sr.edu.sa
Contact: Ahmed Abduljalil 699 595449479 13110033@srcolleges.org

Locations
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Saudi Arabia
Sulaiman AlRajhi Colleges Not yet recruiting
Al Bukairiyah, Qassim, Saudi Arabia, 51941, PO Box 777
Contact: Nazmus Saquib, Phd    966 533445899    a.saquib@sr.edu.sa   
Principal Investigator: Nazmus Saquib, Phd         
Sub-Investigator: Ahmed Abduljalil         
Sponsors and Collaborators
Sulaiman AlRajhi Colleges
Investigators
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Principal Investigator: Nazmus Saquib, Phd SRC

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Responsible Party: Sulaiman AlRajhi Colleges
ClinicalTrials.gov Identifier: NCT03776448     History of Changes
Other Study ID Numbers: SulimanAC-BlackseedOil
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs