Purpose and Objective: Compare the incidence of taste alteration in treatment vs. control arms and Compare weight loss in treatment vs. control arms
After patients is explained all potential risks and study guidelines all patients will be given an ICF to sign if they wish to participate. Once the ICF has been signed by patient approximately between 3-5 days will undergo a screening to determine protocol eligibility. If patients qualifies (eligible) for study patients will be randomly assigned either to the miracle fruit intervention or to supportive measures at first and later participants will cross over to the other intervention
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
one miracle fruit tablet of 100 mg 10-15 minutes before lunch and dinner versus supportive measures. Patients assigned to receive the miracle fruit will receive written instructions regarding the use of the fruit. Patients should put the fruit tablet or powder in the mouth and gently chew/suck to dissolve and cover the tongue with the powder
Compare the incidence of taste alteration in treatment vs. control arms
Taste alteration will be assessed using questions from the Wickham questionnaire of taste alterations. Patient responses to these questions will be transformed to a 0 to 100 scale.
Time frame: 12 months
Compare weight loss in treatment vs. control arms
Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight.
Time frame: 12 months
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