NF-1, Nutraceutical Intervention

NCT ID: NCT05363267

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2026-08-31

Brief Summary

The treatment plan is identical for all participants with the exception of the curcumin dose level that is assigned at study enrollment. Participants are instructed to take the curcumin and olive oil one after the other (order does not matter) twice a day on an empty stomach ideally 30 minutes before breakfast and dinner.

Curcumin and high phenolic extra virgin olive oil (HP-EVOO) may continue for up to 12 months in the absence of unacceptable side effects.

Conditions

Neurofibromatosis 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Curcumin with high phenolic extra virgin olive oil (HP-EVOO)

Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment.

Group Type: EXPERIMENTAL

curcumin, high phenolic extra virgin olive oil (HP-EVOO)

Intervention Type: DIETARY_SUPPLEMENT

identical for all participants with the exception of the curcumin dose level

Dose 1: 1000 mg Curcumin daily dose with 1 capsule and 25 ml HP-EVOO volume at morning and night Dose 2: 2000 mg Curcumin daily dose with 2 capsules and 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules and 25 ml HP-EVOO volume at morning and night

Interventions

curcumin, high phenolic extra virgin olive oil (HP-EVOO)

identical for all participants with the exception of the curcumin dose level

Dose 1: 1000 mg Curcumin daily dose with 1 capsule and 25 ml HP-EVOO volume at morning and night Dose 2: 2000 mg Curcumin daily dose with 2 capsules and 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules and 25 ml HP-EVOO volume at morning and night

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

curcumin; high phenolic extra virgin olive oil (HP-EVOO)

Eligibility Criteria

Inclusion Criteria

• NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
• Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
• Aged 18 years or older at the time of written consent
• Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care

Exclusion Criteria

• Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
• Conditions requiring systemic immunosuppression
• Swallowing difficulties or strong gag reflex which may interfere with study compliance
• Any comorbidities that may affect study participation in the judgement of enrolling investigator
• Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
• Treatment with high phenolic olive oil or curcumin within six months of study entry
• Known pregnancy or anticipated conception during the 1 year study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Moertel, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, Univeristy of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2021LS032

Identifier Type: -

Identifier Source: org_study_id