Fitness and Nutrition in Glioma

August 29, 2025 updated by: NYU Langone Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Diagnosed with Malignant Glioma
Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.
Behavioral: Modified Atkins Diet
The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.
Behavioral: Fitness Program
12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Ketone Levels
Time Frame: Baseline, Week 12
Baseline, Week 12
Change in Resting Heart Rate
Time Frame: Baseline, Week 12
Baseline, Week 12
Change in 400-meter Walk Time
Time Frame: Baseline, Week 12
Time to complete 400-meter-long distance corridor walk.
Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Chest Press
Time Frame: Baseline, Week 12
The 1RM for chest press is the maximum weight an individual can perform for a chest press for one repetition.
Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Leg Press
Time Frame: Baseline, Week 12
The 1RM for chest press is the maximum weight an individual can perform for a leg press for one repetition.
Baseline, Week 12
Change in Satisfaction With Life Scale (SWLS) Score
Time Frame: Baseline, Week 12
5-item assessment of satisfaction with life. Each item is rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 5-35; higher scores indicate greater satisfaction.
Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score
Time Frame: Baseline, Week 12
The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score for the Anxiety subscale is the sum of the respective seven items. The total score ranges from 0-21; higher scores indicate greater anxiety.
Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) Score
Time Frame: Baseline, Week 12
The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the items; the total score ranges from 0-42; higher scores indicate greater anxiety and depression.
Baseline, Week 12
Change in Fatigue Severity Scale (FSS) Score
Time Frame: Baseline, Week 12
The Fatigue Severity Scale (FSS) is a 9-item questionnaire that measures the severity of fatigue and how it affects a person's lifestyle and activities. Items are rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 9 to 63. A higher score indicates greater fatigue severity.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Lee Tessler, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-00654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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