Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt for Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tufts Medical Center, Boston, MA
Glioma
Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This research is being conducted to see if patients diagnosed with high grade gliomas can adhere to the supplemented High-Fat Low-Carbohydrate (sHFLC) + KetoPhyt diet, and to see how this diet might affect cancer cells in the bloodstream. This diet is experimental and is not routinely prescribed for patients with high-grade gliomas. The results of this study may be used to support larger studies investigating possible anti-tumor affects of the sHFLC + KetoPhyt diet.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At Cycle 1 Day 1 and at Cycle 6 Day 1 (Each cycle is 28 days)

Day 28
Change from baseline in pro-inflammatory markers and exosome biomarkers at 24 weeks
Day 28
Number of participants not able to adhere the sHFLC + KetoPhyt Diet
Day 28
Change from baseline between the patient's glucose and ketone levels at 24 weeks as assessed by the Glucose/Ketone Index (GKI)
Change from baseline between the patient's gut microbiome at 24 weeks as assessed by 16s ribosomal sequences.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt · No Placebo Group · N/A

Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
DietarySupplement
Experimental Group · 1 Intervention: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at cycle 1 day 1 and at cycle 6 day 1 (each cycle is 28 days)
Closest Location: Tufts Medical Center · Boston, MA
Photo of tufts medical center 1Photo of tufts medical center 2Photo of tufts medical center 3
2013First Recorded Clinical Trial
4 TrialsResearching Glioma
404 CompletedClinical Trials

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
228 Previous Clinical Trials
238,585 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
For patients treated with external beam radiation (XRT), interstitial brachytherapy or radiosurgery, an interval of > 4 weeks must have elapsed from completion of XRT to pre-registration.
You have a performance status of 2 or less.
You have not received any chemotherapy or radiotherapy for cancer in the past 3 months.
You have an absolute neutrophil count (ANC) of at least 1500/mm3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References