Fish oil fails to deliver in nerve damage trial
NCT ID NCT05145452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether high-dose fish oil supplements could improve nerve function in people with prediabetes and early diabetic neuropathy. Researchers planned to enroll 40 adults aged 55–80, but the trial was terminated early with only 31 participants. Participants took either fish oil pills or a placebo for six months, and nerve function was measured at three and six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fish oil (n-3 polyunsaturated fatty acids)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help manage nerve damage from diabetes.
- What could go wrong
- This was a small, early trial that was terminated, so results are limited. Fish oil may not improve nerve function, and high doses can cause side effects like fishy aftertaste or digestive issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
31 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Jun 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
55 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * age: ≥55 and ≤80 years * BMI: ≥25.0 and ≤39.9 kg/m2; * normal plasma glucose (fasting plasma glucose \<100 mg/dl and plasma glucose 2 h after a 75 g glucose challenge \<140 mg/dl) for the control group and impaired fasting plasma glucose (≥100 mg/dl) or impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) or both for the intervention groups Exclusion Criteria: * age: \<55 and \>80 years * BMI: \<25.0 and \>39.9 kg/m2 * fasting plasma glucose ≥100 mg/dl or plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl for the control group and normal plasma glucose (fasting plasma glucose \<100 mg/dl, plasma glucose at 2 h after 75 g glucose ingestion \<140 mg/dl) for the intervention groups * treatment for T2D, except for metformin * regular structured high-intensity exercise \>150 min total per week * significant neurological or other organ system dysfunction (e.g., progressive neuromuscular disease, unstable angina, vasculitis, certain cardiopulmonary diseases, cancer that has been in remission for \<5 years, dementia, allergies to the dietary supplement) or significant ambulatory impairments (e.g., limb amputations, being wheelchair-bound) * use of certain medications that are incompatible with the study procedures (e.g., certain anticoagulants) or could confound the study outcomes (e.g., anabolic steroids, metronidazole, etc) alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking \>20 cigarettes per week * regular consumption of fish oil supplements or \>2 servings of fatty fish per week * x) prisoners, and persons who are unable to grant voluntary informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Washington University
St Louis, Missouri, 63110, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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