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SUSPENDED
NCT04866810
NA

The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: The gut microbiome is made up microorganisms. These include the good and bad bacteria that live in the digestive tract. Changes in the gut microbiome have been linked to the development of cancer. Researchers want to learn more about the effects of modulating the microbiome with diet and exercise. Objective: To see if nutritional intake and physical activity change the gut microbiome in people with melanoma. Eligibility: Adults age 18 and older with previously untreated melanoma who will be getting immunotherapy treatment for their disease. Design: Participants will not have visits at NIH. They will have phone calls or videocalls. Participants will be screened with a medical history and medical record review. Participants will give stool samples. They will fill out surveys about their health, feelings, diet, and exercise. Participants will be put in 1 of 2 groups. They will follow their group s plan for 4 months. They will be contacted throughout the study. Intervention Group participants will follow a plant-based, high-fiber diet. They will do at least 150 minutes of moderate or 75 minutes of high-intensity exercise per week. They will have sessions with psychology staff to help them make positive lifestyle changes. Control Group participants will be taught healthy eating and exercise guidelines. But they will not be asked to change their diet or exercise habits. All participants will record what they eat in the MyFitnessPal app. They will get a scale to measure their weight each week. They will wear a Garmin(R) physical activity tracker at all times. They can take the tracker off to bathe or shower. Participation will last for 6 months....

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-07-25

Completion Date

2027-10-31

Last Updated

2026-04-27

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Intervention Arm

High fiber, plant based diet + exercise prescription with ACT sessions

BEHAVIORAL

Control

Standard diet and exercise recommendations

Locations (2)

Loma Linda University

Loma Linda, California, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States