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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
160
Dietary supplement N-111
Dietary placebo
Optimal Health Research
Salt Lake City, Utah, United States
KLE Academy of Higher Education & Research
Belagāve, Karnataka, India
Indian Institute of Research
Mumbai, India
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.
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.
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.
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.
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