NCT07464691Not yet recruiting
Effect of Prebiotics in Saudi Adults With Type 2 Diabetes
Effect of Prebiotics in Saudi Adults With Type 2 Diabetes: Randomized Control Trail
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 13 Sept 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07464691
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 13 Sept 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of weight-loss treatments within 3 months before inclusion
- Diabetic patients on acarbose, metformin (\> 1 g/day), and GLP-1 medications.
- Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition.
- Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction.
- Use of pre/probiotics or fiber supplements within 3 months before inclusion.
- 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.
Other illness
- Patients with Type 1 diabetes.
- Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis.
- Chronic gastrointestinal disorder (except irritable bowel syndrome).
- Patients with a history or symptoms of obstruction or Inflammatory bowel disease
- Any immune-compromised disease.
Other
- Pregnant \& breastfeeding females.
- Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements).
- Autonomic neuropathy
- Daily alcohol consumption \> 30 g.
- Involvement in another clinical trial in the past 6 months.
- Any legal incompetence or mental inability to provide consent.
Who the study is looking for
- 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)
Age in the registry: 45 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Abdullah bin Abdulaziz University Hospital Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.