Diet Effect on Cancer Treatment Outcome

October 1, 2024 updated by: Optimal Health Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India, 400028
        • Indian Institute of Research
    • Karnataka
      • Belagave, Karnataka, India, 590010
        • KLE Academy of Higher Education & Research
  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Optimal Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vegetarian N-111 group
The group will use a vegetarian diet with the active compactor N-111.
Dietary supplement: Dietary Supplement: N-111
Dietary supplement N-111
Active Comparator: Non-vegetarian N-111 group.
The group will use a non-vegetarian diet with the active compactor N-111.
Dietary supplement: Dietary Supplement: N-111
Dietary supplement N-111
Placebo Comparator: Vegetarian placebo group
The group will use a vegetarian diet with a placebo.
Other: Placebo
Dietary placebo
Placebo Comparator: Non-vegetarian placebo control group
The group will use a non-vegetarian diet with a placebo.
Other: Placebo
Dietary placebo
No Intervention: Vegetarian control group
The group will use a vegetarian diet without the active compactor N-111 or the placebo.
No Intervention: Non-vegetarian control group
he group will use a non-vegetarian diet without the active compactor N-111 or the placebo.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimal Health Research

Investigators

  • Study Chair: EA Jeppsen, MD, Optimal Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

June 4, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N-111012422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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