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Evaluation of the classical 4:1 ketogenic formula designed, in patients with traumatic brain injury

Preparing and optimizing the classic 4:1 ketogenic formulation and investigating its ketogenic status in patients with traumatic brain injury

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230517058215N1
Enrollment
10
Registered
2023-06-13
Start date
2023-08-06
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury. Diffuse traumatic brain injury with loss of consciousness of unspecified duration, subsequent encounter

Interventions

Intervention 1: The intervention group: in the period of 14 days, to meet the daily energy requirement of 1200 Kcal, they will be receive the designed ketogenic formulation in which the sugar content

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age =18 years Informed written consent of the patient or legal guardian of the patient Glasgow Coma Scale(GCS)<12

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Hypoglycemia less than 70 Hypertriglyceridemia above 200 Hemoglobin concentration <80 g/L Patients diagnosed with sepsis Patients who are in shock and have indications for receiving vasopressors Dysfunction or severe liver and kidney failure Resistant lactic acidosis Hemodynamic or cardiopulmonary metabolic instability Severe infection Known disorders of fatty acid transport and oxidation Severe malnutrition Acute pancreatitis Patients with pyruvate decarboxylase deficiency porphyry

Design outcomes

Primary

MeasureTime frame
Blood beta-hydroxybutyrate assay. Timepoint: It is measured daily in the first 72 hours of the study, then on the 14th day of the end of the study. Method of measurement: blood test.

Secondary

MeasureTime frame
The number of days dependent on the mechanical ventilator, the assessment of Glasgow Outcome Scale scores (GOS), if it is not possible to record the GOS when the patient is discharged, the patient's report will be based on the improvement of the GCS, and finally the mortality rate will be considered as a secondary endpoint. Timepoint: The beginning and end of the study. Method of measurement: GCS and GOS calculation table.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin Shayanfar

Tehran University of Medical Sciences

sh.shaianfar@gmail.com+98 21 8490 2272

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026