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

NCT03776448 | Unknown

• 1 other identifier: SulimanAC-BlackseedOil
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Dietary Supplement: Activated Charcoal Softgels

Interventions

Sativa Nigra oil Softgels DIETARY_SUPPLEMENT

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. .

Also known as: Blackseed oil softgels

Sativa Nigra oil arm

Activated Charcoal Softgels DIETARY_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.

The charcoal arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-60
• Regular Student or Faculty in Sulaiman Alrajhi Colleges
• Consenting for intervention and follow up

You may not qualify if:

• Type I diabetes or Insulin Therapy
• Significant chronic medical illness
• Current use of long-term prescription drugs
• Current use of black seed oil
• Pregnancy

Sponsors & Collaborators

• Sulaiman AlRajhi Colleges: lead

Study Sites (1)

Sulaiman AlRajhi Colleges

Al Bukairiyah, Al-Qassim Region, 51941, PO Box 777, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nazmus Saquib, Phd

  SRC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazmus Saquib, Phd

CONTACT

699 533445899; a.saquib@sr.edu.sa

Ahmed Abduljalil

CONTACT

699 595449479; 13110033@srcolleges.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: January 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)