Effect of Prebiotics in Saudi Adults With Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) represents a major public health challenge and is frequently associated with metabolic abnormalities, including dyslipidemia, obesity, and cardiovascular disease. Emerging evidence indicates that the gut microbiota plays a critical role in regulating host metabolism, inflammation, and glucose homeostasis. Alterations in gut microbial composition have been consistently observed in individuals with T2DM and obesity, suggesting that modulation of gut microbiota may represent a therapeutic target for metabolic disease management.

Prebiotics are non-digestible, fermentable dietary components that selectively stimulate the growth and activity of beneficial gut bacteria. Oligofructose, a well-studied prebiotic carbohydrate, resists digestion in the upper gastrointestinal tract and undergoes fermentation in the colon, leading to the production of short-chain fatty acids that influence glucose metabolism, lipid metabolism, appetite regulation, and inflammatory pathways.

Previous human and animal studies have reported mixed but promising results regarding the effects of oligofructose on glycemic control, lipid profiles, body weight, and inflammatory markers. Some studies demonstrated improvements in fasting blood glucose, lipid parameters, insulin sensitivity, and body weight, while others reported limited metabolic effects despite favorable changes in gut microbiota composition. Differences in study populations, dosages, duration, and baseline metabolic status may account for these inconsistencies.

Individuals with T2DM exhibit distinct gut microbiota profiles compared to non-diabetic individuals, including increased abundance of gram-negative bacteria and elevated circulating lipopolysaccharides, which may contribute to metabolic endotoxemia and insulin resistance. However, data regarding the impact of prebiotic supplementation on gut microbiota and metabolic outcomes in the Saudi population are limited.

This study aims to evaluate the effects of oligofructose supplementation on body weight, glycemic control, lipid profile, inflammatory markers, and gut microbiota composition in individuals with type 2 diabetes. Unlike studies using probiotics, this intervention focuses on modulating endogenous gut microbiota through prebiotic supplementation without introducing live microorganisms.

Hypothesis:

Prebiotic oligofructose supplementation will lead to improvements in body weight, glycemic control, lipid profile, and inflammatory status, mediated in part through favorable modulation of gut microbiota composition.

• Change in Body Mass Index (BMI) [Срок оценки: Baseline, week 4, week 8, and week 12]
• Change in Waist Circumference [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in Hip Circumference [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in Body Composition [Срок оценки: Baseline and week 12.]
• Change in Total Cholesterol [Срок оценки: Baseline, week 4, week 8, and week 12]
• Change in LDL cholesterol [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in HDL Cholesterol [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in serum Triglycerides level [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in serum C-Reactive Protein (CRP) [Срок оценки: Baseline, week 4, week 8, and week 12]
• Change in serum Interleukin-6 (IL-6) [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in serum Tumor Necrosis Factor-alpha (TNF-α) [Срок оценки: Baseline, week 4, week 8, and week 12.]
• Change in Gut Microbiota Composition [Срок оценки: Baseline and Week 12]