Opening soonNot applicableInterventional
What this study is about
This study will explore how a natural food ingredient called oligofructose affects blood glucose levels, lipid profiles, inflammation biomarkers, and gut bacteria in Saudi adults with type 2 diabetes. Oligofructose is a type of dietary fiber found in foods such as onions, garlic, and bananas. It is known to help the growth of "good" bacteria in the intestine, which may improve digestion and metabolism. A total of 100 adults (50 with type 2 diabetes and 50 without diabetes) will take part in this research. Participants will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Blood tests will be done at the beginning and at weeks 4, 8, and 12 to check changes in blood glucose, lipid profiles, and inflammation. The goal of this study is to find out whether adding oligofructose to the diet can help people with diabetes improve their blood glucose control, reduce inflammation, and support a healthier balance of gut bacteria.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age45 Years to 60 Years
SexAll
Healthy volunteersAccepted
ConditionType 2 Diabetes, Metabolic Health, Inflammation, Gut Microbiome, Obesity
Full registry criteria
Inclusion Criteria: * Saudi, both males and females. * Aged between 45-60 years old * BMI between 25 - 30 kg/m2 * No antibiotic use for the last six months Cases: * Type 2 diabetes. * Duration of diabetes ≥ 5 years * HbA1c ≥ 6.5-8.0 Controls: (subjects with normal OGTT results) * Fasting plasma glucose (FPG) \< 100 mg/dl (5.6mmol/l) * A1C less than 5.7% * 2-hour post-load glucose \< 140 mg/dl (7.8 mmol/l) Exclusion Criteria: 1. Patients with Type 1 diabetes. 2. Pregnant \& breastfeeding females. 3. Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis. 4. Use of weight-loss treatments within 3 months before inclusion 5. Diabetic patients on acarbose, metformin (\> 1 g/day), and GLP-1 medications. 6. Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition. 7. Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction. 8. Chronic gastrointestinal disorder (except irritable bowel syndrome). 9. Patients with a history or symptoms of obstruction or Inflammatory bowel disease 10. Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements). 11. Use of pre/probiotics or fiber supplements within 3 months before inclusion. 12. Any drug that can interfere with food absorption or gut flora, such as chronic consumption of loperamide, cholestyramine, antacids, H2-receptor blockers, proton pump inhibitors, fibrates, corticosteroids, or sex steroids, omega-3 unsaturated fatty acids acid, or anti-inflammatory drugs. 13. Autonomic neuropathy 14. Any immune-compromised disease. 15. Daily alcohol consumption \> 30 g. 16. Involvement in another clinical trial in the past 6 months. 17. Any legal incompetence or mental inability to provide consent.
Primary outcomes
Change in fasting blood glucoseBaseline, week 4, week 8, and week 12Change in fasting blood glucose (mmol/L) from baseline, measured from venous blood samples collected using standard laboratory assays.
Change in fasting insulinBaseline, week 4, week 8, and week 12.Change in fasting insulin (µIU/mL) measured from venous blood samples using standard laboratory assays.
Change in HbA1cBaseline, week 4, week 8, and week 12.Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
