Resistant starch diet in prediabetes: protocol for a multicentre randomised controlled trial
This paper describes only the protocol of an ongoing RCT testing an optimised carbohydrate diet (~40 g/day resistant starch) versus conventional diet in 250 adults with prediabetes.
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What the study showed
No efficacy data are presented; the trial has not yet been completed. The planned primary outcome is the change in postprandial glycaemic response measured by incremental area under the curve (iAUC). The intervention involves increased fibre intake (20–40 g/1000 kcal) and reduced rapidly digestible starch and free sugars over 6 months, with a 3-month follow-up.
How it was done
Multicentre, parallel-arm, randomised controlled trial enrolling 250 adults with prediabetes, allocated to an optimised carbohydrate diet (OCD) or a guideline-based conventional diet for 6 months.
Risk of bias
As a protocol paper, no outcome data are available; actual results may deviate from planned estimates. Dietary blinding is inherently limited, and adherence to 40 g/day resistant starch over 6 months is uncertain.
What this study does NOT prove
This protocol does not prove efficacy, safety, or superiority of the OCD over conventional dietary guidance.
In clinical practice
No clinical practice change is warranted based on a protocol alone. Clinicians should monitor publication of the trial results.
Limitations
As a protocol paper, no outcome data are available; actual results may deviate from planned estimates. Dietary blinding is inherently limited, and adherence to 40 g/day resistant starch over 6 months is uncertain.
Technical appendix
Version history
- 1.0 · 2026-09-11 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.