Research paper
Investigating the Neuroprotective Effect of Oral Omega-3 Fatty Acid Supplementation in Type 1 Diabetes (nPROOFS1): A Randomized Placebo-Controlled Trial
Study answer
What this study found
Compared with placebo, six-month n-3 PUFA supplementation increased CNFL by 2.70 mm/mm2 (95% CI 1.64–3.75; P<0.001). CNFD increased by 4.98 nerves/mm2 (95% CI 2.51–7.44; P=0.004) and CNBD by 11.23 branches/mm2 (95% CI 7.01–15.45; P=0.002). Omega-3 Index increased by 3.3 percentage points (95% CI 2.4–4.2). Corneal sensitivity and most peripheral nerve function measures showed no between-group differences; adverse events were similar. Tear break-up time favored n-3 PUFA. Authors conclude that long-chain omega-3 PUFA supplementation induces corneal neuroregeneration and may modulate peripheral…
- Study & population
- Design: single-center, double-masked, randomized, two-arm parallel-group, superiority, placebo-controlled trial.
- Intervention
- Active: oral long-chain omega-3 PUFA supplements totaling 1,800 mg/day (1,080 mg EPA + 720 mg DHA), taken as two capsules daily for 180 ± 24 days.
- Key limitation
- Small sample size and single-center design; not powered for most functional neuropathy endpoints; primary endpoint CNFL is a surrogate marker; baseline CNFL and age imbalances; six-month duration may be insufficient to detect changes in traditional neuropathy measures; multiplicity not fully controlled for secondary…
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Open PDFOriginal abstract
This randomized, double-masked, placebo-controlled trial evaluated the effects of oral omega-3 (n-3) fatty acid supplementation on peripheral nerves in type 1 diabetes. Participants with type 1 diabetes were assigned (1:1) to n-3 (1,800 mg/day fish o…