Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT03950635
Eligibility Criteria:
Inclusion Criteria:
* Melanoma resected within the last 5 years, currently no evidence of disease (NED) and not on systemic therapy.
* Body mass index (BMI) 18.5-40 kg/m\^2.
* English-speaking.
* Self-reported willingness to exclusively eat the provided diets.
* Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
* Creatinine (Cr) \< 1.5 mg/dL.
* Liver function tests (LFTs) 2 x upper limit of normal (ULN).
* Fasting glucose \< 125 mg/dL.
* Women of child-bearing (WOCP) potential must have negative urine pregnancy test (UPT) within 1 week prior to dual x-ray absorptiometry (DEXA) scan.
Exclusion Criteria:
* Systemic treatment for melanoma within the past 1 year.
* Medical contraindications to the intervention diet as determined by the treating physician.
* Self-reported major dietary restrictions related to the intervention.
* Diagnosis of diabetes mellitus type I or type II that requires medical treatment.
* Unable or unwilling to undergo study procedures.
* Antibiotic use within the last 30 days (self-reported and/or noted by the treating physician).
* Regularly taking probiotics, fiber supplements, or bile acid sequestrants, exogenous ketones, weight loss supplements, appetite suppressants, carnitine supplements, creatine supplements or diuretics within the last 30 days (self-reported and/or noted by the treating physician).
* Currently following a ketogenic diet with \> 70% calories derived from fat or consuming \> 40 grams of fiber per day or a vegetarian or vegan diet.
* Current self-reported smoker or heavy drinker (defined as \> 14 drinks per week) or current self-reported illicit drug use.
* Pregnant or lactating.
* Low density lipoprotein (LDL) \> 200 mg/dL (within 28 days of screening).
* Triglycerides \> 350 mg/dL (within 28 days of screening).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03950635
Study Brief:
Protocol Section:
NCT03950635