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Dietary Supplement

Nutraceuticals for Neurofibromatosis

Phase 1
Recruiting
Led By Christopher Moertel, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years or older at the time of written consent
NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (12 months)
Awards & highlights

Study Summary

This trial is testing different doses of curcumin to see which is most effective in reducing inflammation in people with colitis. Participants take curcumin and olive oil twice a day for up to 12 months.

Who is the study for?
This trial is for adults over 18 with Neurofibromatosis (NF1) who have measurable skin neurofibromas. They must be able to give consent and not be on certain cancer drugs, immunosuppressants, or have swallowing issues that could affect taking the treatment. Pregnant individuals or those planning pregnancy during the study are excluded.Check my eligibility
What is being tested?
The trial tests curcumin and high phenolic extra virgin olive oil (HP-EVOO) taken twice daily before meals for up to a year to see if they can help with NF1 symptoms. The only difference between participants is the dose of curcumin assigned when they join.See study design
What are the potential side effects?
While specific side effects aren't listed, participants will stop treatment if they experience any unacceptable side effects related to the nutraceuticals being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with NF1 through genetic testing or NIH criteria.
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I have visible skin tumors due to neurofibromatosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (12 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
The primary objective of this study is to establish the safety and preliminary activity of curcumin and oleocanthal-rich olive oil supplementation in adult NF-1 persons with cutaneous neurofibromas.
Secondary outcome measures
Characterize the toxicities associated with the planned intervention
To assess the effect of the intervention on quality of life
To determine preliminary efficacy of the intervention
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Curcumin with high phenolic extra virgin olive oil (HP-EVOO)Experimental Treatment1 Intervention
Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,607 Total Patients Enrolled
Christopher Moertel, MDPrincipal InvestigatorMasonic Cancer Center, Univeristy of Minnesota
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

curcumin (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05363267 — Phase 1
Neurofibromatosis Research Study Groups: Curcumin with high phenolic extra virgin olive oil (HP-EVOO)
Neurofibromatosis Clinical Trial 2023: curcumin Highlights & Side Effects. Trial Name: NCT05363267 — Phase 1
curcumin (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363267 — Phase 1

Frequently Asked Questions

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

Can individuals consume HP-EVOO and curcumin without risking their health?

"Our team at Power has rated the safety of curcumin, high phenolic extra virgin olive oil (HP-EVOO) a 1 due to only limited data supporting its efficacy and security in this Phase 1 trial."

Answered by AI

How many individuals have enrolled in the research project?

"Correct. According to clinicaltrials.gov, the trial initially went live on July 6th 2022 and has been edited as recently as August 23rd of this year; 18 participants are needed from one medical centre."

Answered by AI

Is this trial actively seeking participants?

"According to the record on clinicaltrials.gov, this medical trial is currently open for enrolment and has been since July 6th 2022 at the latest. The study was most recently updated on August 23rd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Masonic Cancer Center, University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
NF-1, Nutraceutical Intervention
2022. "NF-1, Nutraceutical Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363267.
All > Neurofibromatosis Type 1 > Neurofibromatosis
~2 spots leftby Aug 2024
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