Diet Effect on Cancer Treatment Outcome

• Sponsor: Optimal Health Research (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05410002
• Collaborator: (none)
• Enrollment: 160
• Locations: 3
• Arms: 6
• Anticipated Duration (Months): 14.9
• Patients Per Site: 53.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Breast; Cancer Prostate	Dietary Supplement: Dietary Supplement: N-111; Other: Placebo	Phase 1

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
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized interventional parallel studyRandomized interventional parallel study
• 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.
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Aug 14, 2023
• Anticipated Study Completion Date: Dec 14, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optimal Health Research	Salt Lake City	Utah	United States	84117
2	KLE Academy of Higher Education & Research	Belagave	Karnataka	India	590010
3	Indian Institute of Research	Mumbai		India	400028

Sponsors and Collaborators

• Optimal Health Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Optimal Health Research
• ClinicalTrials.gov Identifier: NCT05410002
• Other Study ID Numbers: N-111012422
• First Posted: Jun 8, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Optimal Health Research: Cancer

Study Results

No Results Posted as of Jul 20, 2022