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Dietary Supplement

Diet + N-111 Supplement for Cancer

Phase 1

Waitlist Available

Research Sponsored by Optimal Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers

Prostate cancer as determined by a Transrectal Biopsy with associated Prostate-specific antigen blood work

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of month 3.

Awards & highlights

Study Summary

This trial will compare the effect of two different diets on cancer patients receiving N-111.

Who is the study for?

This trial is for individuals with a confirmed diagnosis of breast cancer via Fine Needle Biopsy or open biopsy and specific blood markers, or prostate cancer confirmed by Transrectal Biopsy with certain blood work. It's not open to those without these specific diagnoses.Check my eligibility

What is being tested?

The study examines the effects of two different diets on the treatment outcomes in patients taking N-111, a dietary supplement. Participants will either receive this supplement or a placebo to see which diet works better.See study design

What are the potential side effects?

Since this trial involves dietary supplements rather than drugs, side effects may be minimal but could include digestive discomfort or allergic reactions depending on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with breast cancer through a biopsy.

Select...

My prostate cancer was confirmed by a biopsy and PSA blood test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of month 3.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of month 3.

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of month 3. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Active Comparator: Non-vegetarian N-111 group.

Active Comparator: Vegetarian N-111 group

Secondary outcome measures

Placebo Comparator: Non-vegetarian placebo control group

Placebo Comparator: Vegetarian placebo group

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Vegetarian control groupActive Control1 Intervention

The group will use a vegetarian diet without the active compactor N-111 or the placebo.

Group II: Non-vegetarian control groupActive Control1 Intervention

he group will use a non-vegetarian diet without the active compactor N-111 or the placebo.

Group III: Non-vegetarian N-111 group.Active Control1 Intervention

The group will use a non-vegetarian diet with the active compactor N-111.

Group IV: Vegetarian N-111 groupActive Control1 Intervention

The group will use a vegetarian diet with the active compactor N-111.

Group V: Non-vegetarian placebo control groupPlacebo Group1 Intervention

The group will use a non-vegetarian diet with a placebo.

Group VI: Vegetarian placebo groupPlacebo Group1 Intervention

The group will use a vegetarian diet with a placebo.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Optimal Health ResearchLead Sponsor

7 Previous Clinical Trials

635 Total Patients Enrolled

2 Trials studying Breast Cancer

150 Patients Enrolled for Breast Cancer

EA Jeppsen, MDStudy ChairOptimal Health Research

1 Previous Clinical Trials

90 Total Patients Enrolled

1 Trials studying Breast Cancer

90 Patients Enrolled for Breast Cancer

Media Library

N-111 (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05410002 — Phase 1

Breast Cancer Research Study Groups: Non-vegetarian placebo control group, Vegetarian control group, Non-vegetarian control group, Vegetarian placebo group, Non-vegetarian N-111 group., Vegetarian N-111 group

Breast Cancer Clinical Trial 2023: N-111 Highlights & Side Effects. Trial Name: NCT05410002 — Phase 1

N-111 (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05410002 — Phase 1

Frequently Asked Questions

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

Are young adults applicable for this research project?

"The recruitment process for this study is targeting individuals that are over 25 and younger than 80."

Answered by AI

Has the non-vegetarian N-111 group received FDA approval?

"The safety of the Non-vegetarian N-111 group is estimated to be a 1 because this is a Phase 1 trial. This limited data supporting safety and efficacy."

Answered by AI

Who might be a good candidate for this clinical trial?

"This trial is looking for 160 individuals who have been diagnosed with breast cancer between the ages of 25 and 80. The following criteria must be met: [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work., A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diet Effect on Cancer Treatment Outcome

2022. "Diet Effect on Cancer Treatment Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05410002.