Actively Recruiting
A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma
Led by NYU Langone Health · Updated on 2025-09-02
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combined effects of a modified Atkins diet and a physical fitness program in adults diagnosed with malignant glioma, a type of high-grade brain tumor. This pilot study aims to explore how these lifestyle changes might impact quality of life and physical fitness over 15 weeks in a small group of 15 participants. The study is led by NYU Langone Health and focuses on behavioral interventions without the use of drugs or devices. Participants will engage in a 15-week program that includes two supervised exercise sessions each week along with a tailored home exercise plan. The fitness regimen is adapted to each participant's physical abilities and available equipment. Alongside the exercise program, participants will follow a modified Atkins diet, which is a low-carbohydrate eating plan balancing protein, fat, and carbohydrates. During the study, participants will be assessed at the start and after 12 weeks for changes in quality of life using the Short Form 36 Version 2, blood ketone levels, resting heart rate, walking time, muscle strength, life satisfaction, anxiety, depression, and fatigue. Researchers will monitor adherence to the program and track the number of participants who complete the full 12-week intervention. The total participation involves regular exercise sessions and diet adherence, with ongoing evaluations to understand the impacts on physical and mental health.
CONDITIONS
Brief Title
Fitness and Nutrition in Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV)
- Karnofsky Performance Status (KPS) 5 70%
- Willing to follow the study intervention and follow-up
- Able to give full informed consent
You will not qualify if you...
- Currently undergoing initial concurrent radiation/chemotherapy
- Severe medical co-morbidities
- Any medical condition which prohibits moderate to vigorous physical activity (60-85% HRmax)
- Any medical condition which prohibits a restrictive diet
- Neurological deficit preventing participation in moderate to vigorous physical activity
- Severe psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 weeks
Participants follow a modified Atkins diet and participate in a fitness program with two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.
Twice weekly supervised exercise sessions plus individualized home exercises
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
C
Cathryn Lapierre
L
Lee Tessler, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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