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NCT Number: NCT06665373

Fitness and Nutrition in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Atkins Diet

Behavioral

The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.

Fitness Program

Behavioral

12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.

Primary outcomes

  1. Change in Short Form (SF)-36 Version 2 Score

    Time frame: Baseline, Week 12

    The SF-36

  2. Number of Participants who Complete Full 12-Week Program

    Time frame: Week 12

Secondary outcomes

  1. Change in Blood Ketone Levels

    Time frame: Baseline, Week 12

  2. Change in Resting Heart Rate

    Time frame: Baseline, Week 12

  3. Change in 400-meter Walk Time

    Time frame: Baseline, Week 12

    Time to complete 400-meter-long distance corridor walk.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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