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

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: Active, not recruiting
• Conditions: Cancer Breast; Cancer Prostate
• Intervention / Treatment: Dietary supplement: Dietary Supplement: N-111; Other: Placebo

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 (Estimated): 160
• Phase: Phase 1

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

6

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	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.	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): June 14, 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): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cancer
• 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