Impact of Fenugreek Supplementation on Obesity and Hyperglycemia Among Diabetic Adults in Saudi Arabia: A Quasi-Experimental Study
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity and Type 2 Diabetes, Hyperglycemia
Sponsor: University of Hail

Cover letter 
 
Protocol Title: Impact of Fenugreek Supplementation on Obesity and Hyperglycemia among 
Diabetic Adults in Saudi Arabia: A Quasi-Experimental Study 
 
ClinicalTrials.gov ID: [Not yet assigned]  
 
Principal Investigator: 
Dr. Bushra Alshammari 
 
Affiliation: 
Medical and Surgical Nursing Department, College of Nursing, University of Hail, Hail, Saudi 
Arabia  
 
Date of Document: 
10 June 2025 
 
 
 

 
Impact of Fenugreek Supplementation on Obesity and Hyperglycemia among Diabetic 
Adults in Saudi Arabia: A Quasi-Experimental Study  
Overweight and obesity are major global public health concerns associated with negative impacts 
on quality of life, increased morbidity, and higher mortality rates. Overweight refers to a state of 
excessive fat accumulation, while obesity is defined as a chronic, complex disease characterized 
by excessive fat deposits that impair health. Overweight is defined as a BMI ranging from 25 to 
29.5, while obesity is defined as a BMI equal to or greater than 30 [1, 2]. 
Overweight and obesity are estimated to be the fifth leading cause of premature death. The WHO 
reported that one in eight people worldwide were living with obesity in 2022. Moreover, 2.5 
billion adults were classified as overweight, with 890 million of them living with obesity. 
Overall, 43% of adults were overweight, and 16% were obese [2, 3–6]. 
The number of obese individuals has almost tripled since 1975. By 2025, obesity is expected to 
surpass 18% in men and 21% in women. Furthermore, the World Obesity Atlas predicts that by 
2035, more than half of the world’s population will be overweight or obese. These statistics 
highlight the urgent need for comprehensive public health strategies to address the rising 
prevalence of obesity across all age groups [2, 3–7]. 
As obesity reaches epidemic proportions globally, people in the Gulf countries have also been 
significantly affected, particularly in high-income, oil-producing nations. The prevalence of 
obesity in Gulf countries ranges from 2% to 55% among adult females and from 1% to 30% 
among adult males [8]. 
Overweight and obesity are associated with numerous chronic health conditions such as 
cardiovascular, respiratory, and gallbladder diseases, as well as Type 2 Diabetes Mellitus 
(T2DM), hypertension, certain types of cancer, osteoarthritis, and asthma. These conditions 
increase the burden on healthcare systems and reduce life expectancy [8–10]. 
T2DM is a chronic metabolic disorder marked by elevated blood glucose levels (hyperglycemia) 
and glucose intolerance, primarily due to the body’s diminished sensitivity to insulin. This 
impairment triggers increased insulin production, which can eventually lead to insulin deficiency. 
In 2021, the global prevalence of T2DM among individuals aged 20 to 79 was 10.5%, with 
projections indicating a rise to 12.2% by 2045 [11–13]. 
T2DM is commonly associated with a cluster of conditions including high blood sugar, insulin 
resistance, dyslipidemia, hypertension, and obesity, which often occur together. The development 
of T2DM is influenced by a combination of genetic, environmental, and behavioral factors. As 
such, addressing this complex condition requires integrated strategies to manage the 
interconnected health issues it involves [11–13]. 
In recent years, conventional medical therapies for obesity have shown limited effectiveness. 
Evidence suggests that obese patients increasingly turn to alternative remedies in an effort to lose 
weight. These remedies include nutritional medicinal plants such as Fenugreek, which is one of 

the oldest and most widely used herbs due to its safety, affordability, availability, and ease of use 
[3, 14–18]. 
Fenugreek has demonstrated medicinal and nutritional benefits. It has been used to reduce body 
weight and manage metabolic complications, as it contains essential active ingredients (e.g., 
flavonoids, fiber, alkaloids, and amino acids) that reduce intestinal absorption of carbohydrates 
and improve glucose regulation in the liver and muscle tissue. It also possesses antidiabetic, 
antibacterial, anticancer, antioxidant, and anti-anorexic properties [16, 19–21]. 
Additionally, Fenugreek may act as an appetite suppressant by increasing the levels of 
cholecystokinin and glucagon-like peptide-1 hormones, which are involved in regulating appetite. 
When added to carbohydrate-containing meals, its high fiber content enhances the sensation of 
fullness among overweight or obese individuals, leading to reduced food intake and weight loss 
[21, 22]. 
Fenugreek may also increase insulin sensitivity by enhancing the insulin signaling pathway 
through upregulation of insulin receptors, thereby promoting glucose uptake and reducing 
postprandial blood glucose levels. Its amino acid content (notably 4-hydroxyisoleucine) 
stimulates insulin release and helps regulate blood sugar, ultimately reducing food cravings and 
promoting weight loss. Therefore, Fenugreek has proven beneficial for patients with diabetes or 
insulin resistance, as it reduces the blood sugar response to carbohydrate meals [23–25]. 
Moreover, Fenugreek has been shown to reduce fat absorption in the intestines and promote the 
breakdown of fat cells. Adding Fenugreek seed extract to a high-fat diet can improve glucose 
markers and lipid metabolism, resulting in weight loss and reduced body fat accumulation [26]. 
Fenugreek may also elevate levels of testosterone and adiponectin hormones. Testosterone is 
associated with increased skeletal muscle mass, which is essential for glucose clearance and 
accounts for over 80% of glucose uptake after meals. Adiponectin, on the other hand, may induce 
fat and weight loss by enhancing glucose utilization and fatty acid oxidation in peripheral tissues 
[27, 28]. 
Recent meta-analyses have shown that Fenugreek supplementation significantly improves 
glycemic control by reducing FBS and HbA1c, enhancing insulin sensitivity, supporting weight 
loss, and improving lipid profiles. These effects may contribute to reducing complications, 
lowering healthcare costs, and supporting Saudi Arabia’s Vision 2030 health goals [7, 29, 30]. 
Overall, Fenugreek presents a promising and culturally appropriate intervention for managing 
T2DM and obesity in the region. This study is of considerable importance in addressing the 
increasing prevalence of T2DM and obesity within Saudi Arabia. As a traditional herbal remedy, 
Fenugreek has garnered attention for its potential therapeutic effects on metabolic disorders [7, 
30]. 
The significance of this study also lies in the potential impact of Fenugreek supplementation on 
managing obesity and hyperglycemia among diabetic adults in Saudi Arabia—a country with 
some of the highest rates of diabetes and obesity worldwide [31]. 

As of 2024, the prevalence of obesity among Saudi adults ranges from 20% to 39%. Common 
obesity-related 
complications 
include 
hypertension 
(67.6%), 
T2DM 
(60.7%), 
and 
hypercholesterolemia (51.3%). There is a well-established link between rising BMI and increased 
risk for these health conditions. Additionally, the economic burden of obesity in Saudi Arabia is 
substantial, with treatment and management costs estimated at around 6.4 billion US dollars [31]. 
In Saudi Arabia, where obesity and T2DM are prevalent due to lifestyle factors, Fenugreek offers 
a culturally suitable and cost-effective dietary intervention. Investigating its effects on obesity 
and glycemic control could support its inclusion in national health strategies and the development 
of comprehensive treatment plans that integrate both medical and non-medical approaches [31, 
32]. 
This study aims to address the existing research gap by generating region-specific evidence on the 
effectiveness of Fenugreek supplementation. The findings will support evidence-based practice 
and inform public health policies tailored to the Saudi population. Ultimately, the study seeks to 
improve health outcomes, ensure patient safety, and reduce morbidity and mortality among adults 
with diabetes and obesity. 
Aim of the study 
This study aimed to examine the impact of Fenugreek supplementation on obesity and 
hyperglycemia among diabetic adults in Hail city, Saudi Arabia  
Research hypotheses 
H1: Diabetic adults who consume Fenugreek supplementation exhibit less BMI will be compared 
to those who do not consume it.  
H2: Diabetic adults who consume Fenugreek supplementation exhibit lower blood glucose levels 
will be compared to those who do not consume it. 
2. Materials and Methods 
Study design  
A quasi-experimental research design (pretest-posttest nonequivalent control group design) will 
be adopted in this study. 
Study settings 
This study will be conducted at the diabetic clinics affiliated to Diabetes and Endocrine Center, 
University medical clinics and King Khalid hospital in Hail city, Saudi Arabia. These settings 
will be selected because of their higher turnover of diabetic cases, which will be satisfactory for 
the study. 
Study participant 

A convenience sample of 80 participants will be recruited from the aforementioned settings using 
a non-probability sampling technique. Eligible participants will include male and female adults 
over the age of 22 who are either overweight (BMI ranging from 25 to 29.5 kg/m²) or obese (BMI 
exceeding 30 kg/m²). All participants must have a confirmed diagnosis of Type 2 Diabetes 
Mellitus (T2DM), be cognitively able to participate in the study, and express a willingness to do 
so. However, individuals with diabetes who are undergoing insulin therapy, pregnant or 
breastfeeding women, and those suffering from chronic diseases other than T2DM will be 
excluded from the study. 
Sample size 
The Epi Info 7 statistical program were used to estimate the appropriate sample size for this 
study, based on the following parameters: a population size of 416 participants per month, an 
expected frequency of 50%, a margin of error of 10%, and a confidence level of 95%. According 
to these calculations, the minimum required sample size is determined to be 78 participants. To 
account for potential non-response and to ensure adequate representation, the final sample size 
will be increased to 80 participants. 
 Data collection 
 Data will be collected from each participant through an individually administered interview 
schedule. The structured interview tool, developed by the researchers, will be designed to gather 
both personal and clinical data relevant to the study. Personal data will include participants’ age 
(in years), gender, and Body Mass Index (BMI), which will be calculated using the following 
equation: 
BMI = weight (kg) / height² (m²). 
Weight will be measured in kilograms (kg) using a calibrated scale, with participants wearing 
minimal clothing and no shoes. Height will be measured in meters (m) using a stadiometer, with 
participants standing upright on a flat surface (neither slumping nor stretching), barefoot, and 
with their heels, shoulders, and the back of the head aligned vertically, looking straight ahead 
without tilting the head up or down [33, 34]. 
Clinical data will include: 
Fasting Blood Sugar (FBS) in mg/dL, 
Random Blood Sugar (RBS) in mg/dL, and 
Glycated Hemoglobin (HbA1c) in percentage (%). 
BMI, FBS, and RBS will be measured at four time points: baseline, and at one, two, and three 
months. HbA1c will be assessed at two time points: baseline and at three months.   
Intervention Procedures 

Participants will be equally divided into two groups: a study group and a control group, each 
comprising 40 individuals. Following the provision of informed consent, participants will be 
randomly assigned to either the study group—which will receive Fenugreek supplementation in 
addition to standard care—or the control group, which will receive standard care alone. 
Randomization will be performed using a computer-generated random number list to ensure 
unbiased allocation. 
Due to the practical challenges associated with dietary interventions and the absence of placebo 
controls in this setting, blinding will not be feasible for participants or the researchers 
administering the intervention. Consequently, participants will be aware of their group 
assignments. Nonetheless, outcome assessors and data analysts will remain blinded to group 
allocation throughout the data collection and analysis phases to minimize detection and 
performance biases. 
Participants in the study group will continue their prescribed anti-diabetic treatment and adhere to 
a standardized dietary plan, in addition to consuming Fenugreek seed powder (10 g in sachet 
form) daily before breakfast and dinner for a duration of three months. In contrast, the control 
group will receive only their prescribed anti-diabetic treatment while following the same dietary 
plan. To enhance adherence to the intervention, researchers will maintain weekly telephone 
contact with participants in the study group, emphasizing the importance of compliance with both 
the Fenugreek supplementation and dietary plan. 
Upon completion of the three-month intervention, a comparative analysis will be conducted 
between the study and control groups to evaluate the impact of Fenugreek supplementation on 
obesity and hyperglycemia in adults with T2DM. 
Statistical analysis  
The collected data will be carefully categorized, coded, computerized, tabulated, and will be 
analyzed using the Statistical Package for Social Sciences (SPSS) version 23 program. To explore 
the relationships between the study variables, cross-tabulation will be performed, which will be a 
standard and appropriate approach for identifying associations and distributions of categorical 
data. 
Comparisons between groups of categorical variables will be conducted using the Chi-square test 
(Monte Carlo). This test will be particularly useful when expected frequencies will be low, and 
thus, its use here will be well-justified. For comparisons involving two categories of normally 
distributed quantitative variables, the Student’s t-test will be employed, which will be the 
conventional choice for assessing mean differences between two independent groups. 
Additionally, to compare the three repeated measurements (baseline, one, two, and three months) 
within each group, analysis of variance (ANOVA) with repeated measures will be conducted, 
followed by Bonferroni adjustment to control for multiple comparisons. The application of partial 
Eta squared will be appropriate for determining the effect size of the intervention, thus providing 
insights into the magnitude of observed differences. Throughout the analyses, a 5% significance 

level will be used to judge the statistical significance of the results, aligning with the standard 
threshold in clinical research.  
Ethical consideration 
An Ethical Approval of Scientific Research were obtained from the Research Ethics Committee 
at the University of Hail (Ethical Approval No: H-2025-560), in strict adherence to the principles 
outlined in the Declaration of Helsinki. This ethical clearance ensured that the study design and 
implementation met the highest standards of human subject research ethics. Furthermore, official 
permissions will be secured from the responsible authorities of the respective study settings, 
following a clear and thorough explanation of the study’s objectives and methods to these 
authorities. This careful attention to ethical and administrative approvals underscores the 
researchers' commitment to conducting the study responsibly and in accordance with established 
ethical guidelines.   
Expected Outcomes 
The expected outcomes of this study will include a significant reduction in BMI, FBG, RBS, and 
HbA1c among participants who receive Fenugreek seed powder in addition to standard diabetes 
care. It is anticipated that participants in the intervention group will experience better glycemic 
control and more favorable weight management outcomes compared to those receiving standard 
care alone. 
Furthermore, this study is expected to provide evidence supporting the use of Fenugreek as a 
culturally acceptable, affordable, and safe dietary supplement that complements conventional 
treatment for adults with T2DM and obesity in Saudi Arabia. The findings may contribute to local 
public health strategies aimed at non-pharmacological interventions for chronic metabolic 
diseases. 
 
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