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CompletedNCT05410002Updated Oct 3, 2024

Diet Effect on Cancer Treatment Outcome

A Phase 1 interventional study of Dietary Supplement: N-111 and Placebo in Cancer Breast and Cancer Prostate, sponsored by Optimal Health Research. Completed at 3 sites in 2 countries. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Optimal Health Research · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
25 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer Breast
  • Cancer Prostate

Keywords

  • Cancer
03

In context

Lead sponsor

Optimal Health Research is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • •Patients without the positive diagnosis of breast or prostate cancer.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • 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

  • 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

  • Placebo comparator
    Vegetarian placebo group

    The group will use a vegetarian diet with a placebo.

    Other: Placebo

  • Placebo comparator
    Non-vegetarian placebo control group

    The group will use a non-vegetarian diet with a placebo.

    Other: 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.

Interventions

  • Dietary supplementDietary Supplement: N-111

    Dietary supplement N-111

  • OtherPlacebo

    Dietary placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: End of month 3.

  2. 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.

    Time frame: End of month 3.

Secondary outcomes

  1. Placebo Comparator: Vegetarian placebo group

    Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

    Time frame: End of month 3.

  2. 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.

    Time frame: End of month 3.

07

Study locations

3 sites
  • Optimal Health Research
    Salt Lake City, Utah 84117, United States
  • KLE Academy of Higher Education & Research
    Belagave, Karnataka 590010, India
  • Indian Institute of Research
    Mumbai, 400028, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05410002
Lead sponsor
Optimal Health Research
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
Oct 12, 2022
Primary completion
Apr 1, 2024
Completion
Oct 1, 2024
Last update
Oct 3, 2024

Study contacts

EA Jeppsen, MD
study chair · Optimal Health Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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