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The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegetarian N-111 group | Active Comparator | The group will use a vegetarian diet with the active compactor N-111. |
|
| Non-vegetarian N-111 group. | Active Comparator | The group will use a non-vegetarian diet with the active compactor N-111. |
|
| Vegetarian placebo group | Placebo Comparator | The group will use a vegetarian diet with a placebo. |
|
| Non-vegetarian placebo control group | Placebo Comparator | The group will use a non-vegetarian diet with a placebo. |
|
| Vegetarian control group | No Intervention | The group will use a vegetarian diet without the active compactor N-111 or the placebo. | |
| Non-vegetarian control group | No Intervention | he group will use a non-vegetarian diet without the active compactor N-111 or the placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: N-111 | Dietary Supplement | Dietary supplement N-111 |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EA Jeppsen, MD | Optimal Health Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Health Research | Salt Lake City | Utah | 84117 | United States | ||
| KLE Academy of Higher Education & Research |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Randomized interventional parallel study
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Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.
| Placebo | Other | Dietary placebo |
|
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
| End of month 3. |
| Belagāve |
| Karnataka |
| 590010 |
| India |
| Indian Institute of Research | Mumbai | 400028 | India |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |