Diet Effect on Cancer Treatment Outcome

Cancer Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05410002
• Other study ID #: N-111012422
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 12, 2022
• Est. completion date: June 14, 2024

Study information

• Verified date: April 2024
• Source: Optimal Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 14, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Breast
• Cancer Prostate

Intervention

Dietary Supplement:
• Dietary Supplement: N-111
Dietary supplement N-111

Other:
• Placebo
Dietary placebo

Locations

Country	Name	City	State
India	KLE Academy of Higher Education & Research	Belagave	Karnataka
India	Indian Institute of Research	Mumbai
United States	Optimal Health Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Health Research

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.