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n-3 Polyunsaturated Fatty Acids

Omega-3 Fatty Acids for Diabetic Neuropathy (NMF Trial)

N/A
Waitlist Available
Led By Bettina Mittendorfer
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥55 and ≤80 years
BMI: ≥25.0 and ≤39.9 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 months
Awards & highlights

NMF Trial Summary

This trial is testing the hypothesis that fish oil-derived n-3 polyunsaturated fatty acids (n-3 PUFA) may improve sensorimotor and cardiovascular autonomic functions in people with impaired glucose tolerance.

Who is the study for?
This trial is for men and women aged 55-80 with prediabetes, indicated by specific glucose levels after a sugar challenge. Participants should have a BMI between 25.0 and 39.9 kg/m2 and evidence of diabetic neuropathy. Excluded are those with certain medical conditions or treatments, alcohol use disorder, heavy smoking, high fish oil intake from diet or supplements, intense exercise habits, treatment for type 2 diabetes (other than metformin), or significant neurological issues.Check my eligibility
What is being tested?
The study tests if n-3 polyunsaturated fatty acids (PUFAs) from fish oil can improve nerve function in prediabetic individuals with sensorimotor neuropathy (SMN) and cardiovascular autonomic neuropathy (CAN). Forty participants will be randomly assigned to receive either n-3 PUFA supplements or placebo daily for six months while their nerve functions are monitored.See study design
What are the potential side effects?
Potential side effects of n-3 PUFAs may include an upset stomach, a fishy aftertaste, loose stools, and possibly increased bleeding risk if taken in high doses. However, these side effects are generally mild.

NMF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 55 and 80 years old.
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You must have a body mass index (BMI) between 25.0 and 39.9.

NMF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiovascular autonomic function
Muscle endurance
Sensorimotor function
Secondary outcome measures
Beta cell function
Glucose tolerance
Insulin sensitivity
+3 more

NMF Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
Subjects randomized to n-3 PUFA will receive a total of 4.2 g/d of fish oil.
Group II: Control groupActive Control1 Intervention
Subjects assigned to the control group will be tested once
Group III: Placebo GroupPlacebo Group1 Intervention
Subjects randomized to placebo will receive 4.2 g/d sunflower oil.

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
360 Previous Clinical Trials
627,904 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,028 Total Patients Enrolled
Bettina MittendorferPrincipal InvestigatorWashington University School of Medicine
4 Previous Clinical Trials
164 Total Patients Enrolled

Media Library

Fish-oil derived n-3 polyunsaturated fatty acids (n-3 Polyunsaturated Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT05145452 — N/A
Diabetic Neuropathy Research Study Groups: Intervention Group, Control group, Placebo Group
Diabetic Neuropathy Clinical Trial 2023: Fish-oil derived n-3 polyunsaturated fatty acids Highlights & Side Effects. Trial Name: NCT05145452 — N/A
Fish-oil derived n-3 polyunsaturated fatty acids (n-3 Polyunsaturated Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145452 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate aim of this medical experiment?

"This clinical experiment, which will span 6 months in duration, seeks to evaluate Cardiovascular autonomic functioning. Additionally, Muscle strength, Oral insulin sensitivity index and Insulin secretion rate shall be observed as secondary outcomes."

Answered by AI

Is the age limit for enrolment in this trial restricted to adults?

"This medical trial has outlined age restrictions as per their inclusion criteria. Prospective patients must be aged 55 or higher, but not over 80 years old."

Answered by AI

Is it possible to participate in this clinical exploration?

"This research project is open to patients aged between 55 and 80 who suffer from diabetic neuralgia. 60 participants in total are required for the trial."

Answered by AI

Is enrollment still open for this research initiative?

"According to clinicaltrials.gov, this research endeavour is still actively searching for participants since the initial posting on January 14th 2021 and last update on June 15th 2022."

Answered by AI

What is the uppermost limit of participants in this trial?

"Affirmative, clinicaltrials.gov has the data to support that this medical trial is actively recruiting participants. This study was initially posted on January 14th 2021 and underwent its most recent update June 15th 2022. Two sites are required for 60 patients to qualify for inclusion in this experiment."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Missouri
What site did they apply to?
Washington University School of Medicine
Washington University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~21 spots leftby Dec 2025