Diet Effect on Cancer Treatment Outcome

A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05410002

Enrollment

160

Registered

2022-06-08

Start date

2022-10-12

Completion date

2024-10-01

Last updated

2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Breast, Cancer Prostate

Keywords

Cancer

Brief summary

The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

Detailed description

The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.

Interventions

DIETARY_SUPPLEMENTDietary Supplement: N-111

Dietary supplement N-111

OTHERPlacebo

Dietary placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.

Intervention model description

Randomized interventional parallel study

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* •Patients without the positive diagnosis of breast or prostate cancer.

Design outcomes

Primary

Measure	Time frame	Description
Active Comparator: Vegetarian N-111 group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Active Comparator: Non-vegetarian N-111 group.	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

Secondary

Measure	Time frame	Description
Placebo Comparator: Vegetarian placebo group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Placebo Comparator: Non-vegetarian placebo control group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

Countries

India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026