A Combination of Prebiotic Inulin and Oligofructose Improve Some of Cardiovascular Disease Risk Factors in Women with Type 2 Diabetes: A Randomized Controlled Clinical Trial.

Randomized controlled clinical trial in adult women with type 2 diabetes who were overweight (BMI >25 kg/m2) and on stable oral antidiabetic therapy. For the active intervention arm, 27 participants were randomized and analyzed; the study was conducted in Iran.

The active regimen was 10 g/day of oligofructose-enriched inulin (Frutafit), given orally for 8 weeks in two 5 g doses taken with breakfast and dinner and water. The comparator was a similar amount of maltodextrin placebo.

Overall, oligofructose-enriched inulin improved several cardiovascular and metabolic risk markers over 8 weeks. Fasting plasma glucose decreased by 19.2 mg/dL and HbA1c by 0.5%, while serum total cholesterol fell by 28.0 mg/dL, LDL-cholesterol by 22.0 mg/dL, and malondialdehyde by 1.7 nmol/ml. Between-group differences were significant for TAC and MDA, while TG, HDL-c, SOD, GSH-Px, and catalase changes were not significant between groups. No adverse events were reported, and the authors concluded the supplement may be a safe and effective adjunct in diabetes management.

The trial was small, single-center, and short duration (8 weeks), which limits certainty and long-term inference. Generalizability is restricted to overweight women with type 2 diabetes on oral therapy, and several secondary outcomes did not differ significantly from placebo. Dietary intake and physical activity were monitored, but residual confounding cannot be ruled out.