Effects of a Ketogenic Diet on Acute Stroke

NCT01997749 | Completed Phase 1

• 1 other identifier: G-1-2013-012
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this controlled, randomized intervention is to investigate whether a fat-based (ketogenic) diet given for a week has a positive effect on blood sugar, mortality and function in patients hospitalized with acute stroke compared to the effect of a usual diet. The study hypothesis is that a ketogenic diet and reduced availability of glucose to the brain cells will reduce the volume of neuronal damage in the brain and improve function. The intervention will take place at the neurological units of Glostrup and Bispebjerg Hospital in Denmark.

Conditions

Acute Stroke

Keywords

stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection

Outcome Measures

Primary Outcomes (3)

• Change from baseline NIHSS (national institute of health stroke scale) at 90 days

  NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke

  Baseline and 90 days

• Change from baseline fasting blood sugar at 7 days

  Baseline and 7 days

• Change from baseline p-C-peptide at 7 days

  Baseline and 7 days

Secondary Outcomes (14)

• Change from baseline p-triglyceride (fasting) at 7 days

  Baseline and 7 days

• Change from baseline p-LDL at 7 days

  Baseline and 7 days

• Change from baseline p-CRP at 7 days

  Baseline and 7 days

• Change from baseline p-beta-hydroxy butyrate at 7 days

  Baseline and 7 days

• Change from baseline p-phosphate at 7 days

  Baseline and 7 days

Study Arms (2)

Ketogenic diet

EXPERIMENTAL

Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion

Dietary Supplement: Ketocal 4:1 (Nutricia); Dietary Supplement: Ketogenic meals

Control diet

ACTIVE COMPARATOR

Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion.

Dietary Supplement: Control diet: Regular diet offered at the hospitals

Interventions

Ketocal 4:1 (Nutricia) DIETARY_SUPPLEMENT

Ketogenic diet

Control diet: Regular diet offered at the hospitals DIETARY_SUPPLEMENT

Control diet

Ketogenic meals DIETARY_SUPPLEMENT

Ketogenic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ischemic or hemorrhagic stroke.
• NIHSS score of at least 5.
• Both primary and recurrent cases.
• Patients with expected hospitalization for a minimum of seven days.
• Adult patients with cognitive ability to give informed consent.
• Patients with writing and orally accepted participation.

You may not qualify if:

• Patients with SAH and traumatic hematoma.
• Patients with pancreatic insufficiency (steatorrhea).
• Patients unable to give informed consent.

Sponsors & Collaborators

• University of Copenhagen: lead
• Glostrup University Hospital, Copenhagen: collaborator
• Bispebjerg Hospital: collaborator

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Stroke; Ketosis; Ischemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders

Study Officials

• Jens Rikardt Andersen, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Med.Sci./Ph.D.

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 28, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

DK (1)