RecruitingInterventional

A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma

NCT ID: NCT06665373Sponsor: NYU Langone HealthLast updated: 2025-09-02

Summary

This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.

Arms & interventions

BehavioralModified Atkins Diet
The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.
BehavioralFitness Program
12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.

Outcome measures

Primary

Change in Short Form (SF)-36 Version 2 Score
The SF-36
Time frame: Baseline, Week 12
Number of Participants who Complete Full 12-Week Program
Time frame: Week 12

Secondary

Change in Blood Ketone Levels
Time frame: Baseline, Week 12
Change in Resting Heart Rate
Time frame: Baseline, Week 12
Change in 400-meter Walk Time
Time frame: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Chest Press
Time frame: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Leg Press
Time frame: Baseline, Week 12
Change in Satisfaction With Life Scale (SWLS) Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) Score
Time frame: Baseline, Week 12
Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, Week 12

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy volunteers: No

Inclusion Criteria: * Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV) * Karnofsky Performance Status (KPS) ≥ 70% * Willing to follow the study intervention and follow-up * Able to give full informed consent Exclusion Criteria: * 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

Study locations (1)

NYU Langone Health

New York, New York, 10016

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