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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Optimal Health Research
- Enrollment
- 160
- Locations
- 3
- Primary Endpoint
- Active Comparator: Non-vegetarian N-111 group.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Placebo Comparator: Non-vegetarian placebo control group(End of month 3.)
- Placebo Comparator: Vegetarian placebo group(End of month 3.)