This trial studies the effects of a fiber-rich diet or a ketogenic (high fat and low carbohydrate) diet in patients with a history of melanoma. A ketogenic diet provides daily calories through a high amount of fat and a very small amount of carbohydrates. A whole-foods, fiber-rich diet provides these calories through a diet based on fruits, vegetables, and whole grains. This study is being done to determine a tolerable diet “dose” by increasing the fiber content or fat content (ketogenic diet) over time and evaluating dietary compliance, tolerance, and biomarker change.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03950635.
PRIMARY OBJECTIVES:
I. Determine the feasibility of controlled dietary intervention studies in patients with history of melanoma.
SECONDARY OBJECTIVES:
I. Determine compliance with a controlled dietary intervention in patients with history of melanoma.
II. Determine the tolerance of dietary fiber and fat content.
III. Determine the effects of controlled dietary interventions on metabolic parameters.
IV. Determine the effects of controlled dietary interventions on the fecal microbiome.
V. Examine the safety of controlled dietary interventions in patients with history of melanoma.
EXPLORATORY OBJECTIVES:
I. Explore the effects of controlled dietary intervention on systemic immunity.
II. Explore the effects of controlled dietary intervention on oxidative stress.
III. Explore changes in body composition with isocaloric dietary interventions.
IV. Explore predictors of biological response (change in metabolic parameters and fecal microbiome) to dietary interventions.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients consume a whole-foods, fiber-rich diet for 6 weeks.
GROUP II: Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
Patients are followed up at 6 weeks after the end of study visit.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJennifer McQuade