Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors
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|ClinicalTrials.gov Identifier: NCT03160599|
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Tumors||Other: ketogenic diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Restricted Calorie Ketogenic Diet
Calorie restriction: The basis of dietary design is 70-85% of individual's total calories. The total calorie is based on patient's activity level and their basal metabolism values, which is obtained from indirect calorimetry or harris-benedict formula.
Treatment will consist of ketogenic diet. KD will consist of 4:1-1:1[fat]:[protein+carbohydrate].Carbohydrate is limited to 10-30 g / day.The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.
Other: ketogenic diet
The treatment is mainly restricted calorie ketogenic diet. KD will consist of 4:1-1:1[fat]:[protein+carbohydrate].Carbohydrate is limited to 10-30 g / day.
- Adverse events of patients on high-fat diet [ Time Frame: 2 year ]The main focus of this period is to recruit patients and collect clinical data for patients with glioblastoma multiforme on restricted calorie ketogenic diet. The safety and tolerability of the treatment will be evaluated.This can be measured by reports of adverse incidences.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160599
|Contact: Yu Hong Deng, M.D.||86 20 firstname.lastname@example.org|
|the Second Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Qian Chen 86 20 81340031|