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The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus

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Editor's note
Dietary fiber's metabolic benefits in diabetes remain largely unexplained—this RCT bridges that gap by measuring how a specific prebiotic shifts microbiota-derived metabolites like short-chain fatty acids, grounding clinical outcomes in microbial mechanism. The finding sits between incremental (fiber interventions are established) and mechanistic (linking dysbiosis reversal to glucose control), filling a genuine evidence gap in the gut ecology-metabolism axis. Internists and endocrinologists managing type 2 diabetes will find this most relevant, particularly those considering microbiota-targeted therapies.

Source: ctgov · Pirogov Russian National Research Medical University · COMPLETED · 2026-05-27

URL: https://clinicaltrials.gov/study/NCT07609992

AI rationale (4/5, tier: emerging): RCT measuring microbiota metabolite changes (short-chain fatty acids) in response to prebiotic intervention; mechanistic focus on gut ecology-metabolism axis.

The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are:

1. To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus. 2. To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus. 3. To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus. 4. To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus.

The observational study is planned to include approximately 80 patients diagnosed with type 2 diabetes mellitus, with 40 patients divided into the main and control groups. In the control group, the necessary information will be collected retrospectively using archived patient data. In the main (study) group, data will

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Published 2026-05-28 · Last kit-update 2026-05-28