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Low-GI vs High-GI Diets for Spinal Cord Injury
N/A
Waitlist Available
Led By Jia Li, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic SCI, At least 1 year after injury, Injury level between Cervical 4 and Lumbar 2, with an American Spinal Injury Association (ASIA) Impairment Scale classification of A-D
Be older than 18 years old
Must not have
Previous diagnosis of heart diseases and/or stroke
Type 1 or insulin-dependent type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in-lab testing - visit 2 - day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a low-glycemic index diet on blood pressure and glucose control in people with chronic spinal cord injuries.
Who is the study for?
This trial is for individuals with chronic spinal cord injury (SCI) at least one year post-injury, between levels C4 and L2, and classified as A-D on the ASIA scale. It's not suitable for pregnant or breastfeeding women, those with type 1 or insulin-dependent type 2 diabetes, recent medication changes, heart diseases/stroke history, or other neurological impairments.
What is being tested?
The study compares the effects of a low-glycemic index (GI) diet versus a high-GI diet on people with SCI. It aims to see which diet better manages blood pressure drops after eating and controls blood sugar levels.
What are the potential side effects?
Potential side effects from dietary changes may include gastrointestinal discomfort such as bloating or gas, changes in bowel habits like constipation or diarrhea, and possible alterations in energy levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a spinal cord injury for over a year, between my neck and upper back, with some level of impairment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had heart disease or a stroke in the past.
Select...
I have type 1 diabetes or insulin-dependent type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in-lab testing - visit 2 - day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in-lab testing - visit 2 - day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 1
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 2
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 3
+5 moreSecondary study objectives
Low-GI Diet on Postprandial Glucose Responses
Low-GI diet on postprandial glycemia - Visit 2
Low-GI diet on postprandial glycemia- Visit 1
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-GI DietExperimental Treatment1 Intervention
Low Glycemic Index Diet
Group II: High-GI DietActive Control1 Intervention
High Glycemic Index Diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-GI Diet
2023
N/A
~20
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,451 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,648 Previous Clinical Trials
2,344,514 Total Patients Enrolled
Jia Li, PhDPrincipal InvestigatorThe University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently changed my medications.You have a neurological condition other than spinal cord injury.I have had a spinal cord injury for over a year, between my neck and upper back, with some level of impairment.I have had heart disease or a stroke in the past.I have type 1 diabetes or insulin-dependent type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Low-GI Diet
- Group 2: High-GI Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.