Diabetes Mellitus Clinical Trial
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.
1. 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
2. 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.
3. Study Setting:
This study will be conducted in the internal clinics of Sulaiman Al Rajhi Colleges in
Qassim region, Kingdom of Saudi Arabia.
4. 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.
5. 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.
6. 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.
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