Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

NCT01820663 | Completed Phase 1

• 1 other identifier: BRH-424
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.

Conditions

Stroke; Ischemic Stroke

Keywords

stroke; ketones; ketogenic diet; impairment; disability

Outcome Measures

Primary Outcomes (1)

• Change in Upper Extremity Fugl Meyer Motor Score

  The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.

  assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge

Secondary Outcomes (1)

• Change in Montreal Cognitive Assessment (MOCA)

  assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge

Study Arms (2)

Modified Atkins Diet

EXPERIMENTAL

Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.

Other: Modified Atkins Diet

Control Diet

PLACEBO COMPARATOR

Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.

Other: Control diet

Interventions

Modified Atkins Diet OTHER

A high fat, high protein, low- carbohydrate diet

Modified Atkins Diet

Control diet OTHER

The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.

Also known as: Low sodium diet, low sodium/ low cholesterol diet, regular diet, diabetic diet

Control Diet

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-99
• First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
• Burke Stroke Rehabilitation Unit Inpatient.
• Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
• Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
• Independence in ADLS/ absence of major impairment prior to stroke

You may not qualify if:

• Hemorrhagic stroke
• Uncontrolled hyperlipidemia with LDL \> 250 on admission
• Uncontrolled Diabetes mellitus with BS \> 300 averaged over the first day of admission
• Nutritional risk as defined by BMI \< 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
• Decreased renal function with eGFR \<30%
• Stage III and IV pressure ulcers
• Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements
• CHF as defined by class III or worse
• Hypersensitivity/allergy to cholesterol lowering medications
• H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors
• Inability to tolerate an oral diet and need for tube feeds
• Cognitively unable to follow instructions.

Sponsors & Collaborators

• Burke Rehabilitation Hospital: lead

Study Sites (1)

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ketosis

Interventions

Diet, Sodium-Restricted; Diet; Diet, Diabetic

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Carolin I Dohle, MD

  Burke Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Attending

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 29, 2013
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)