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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Fasting venous blood glucose
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Sativa Nigra oil Softgels (Dietary Supplement)
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.
Intervention: Activated Charcoal Softgels (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Blood pressure(This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention)
- Gastrointestinal symptoms(This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention)