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Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

Primary Purpose

Stroke, Ischemic Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins Diet
Control diet
Sponsored by
Burke Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, ketones, ketogenic diet, impairment, disability

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria
  • Cognitively unable to follow instructions.

Sites / Locations

  • Burke Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified Atkins Diet

Control Diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Montreal Cognitive Assessment (MOCA)
The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.

Full Information

First Posted
March 13, 2013
Last Updated
February 22, 2016
Sponsor
Burke Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01820663
Brief Title
Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
Official Title
Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burke Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke
Keywords
stroke, ketones, ketogenic diet, impairment, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins Diet
Arm Type
Experimental
Arm Description
Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.
Arm Title
Control Diet
Arm Type
Placebo Comparator
Arm Description
Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.
Intervention Type
Other
Intervention Name(s)
Modified Atkins Diet
Intervention Description
A high fat, high protein, low- carbohydrate diet
Intervention Type
Other
Intervention Name(s)
Control diet
Other Intervention Name(s)
Low sodium diet, low sodium/ low cholesterol diet, regular diet, diabetic diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Upper Extremity Fugl Meyer Motor Score
Description
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.
Time Frame
assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
Secondary Outcome Measure Information:
Title
Change in Montreal Cognitive Assessment (MOCA)
Description
The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.
Time Frame
assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria Cognitively unable to follow instructions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolin I Dohle, MD
Organizational Affiliation
Burke Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be disclosed.

Learn more about this trial

Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

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