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Low-GI vs High-GI Diets for Spinal Cord Injury

N/A
Recruiting
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

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.Check my eligibility
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.See study design
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~in-lab testing - visit 2 - day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and in-lab testing - visit 2 - day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Low-GI Diet on Postprandial Glucose Responses
Low-GI diet on postprandial glycemia - Visit 2
Low-GI diet on postprandial glycemia- Visit 1

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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
844 Previous Clinical Trials
639,497 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,908 Total Patients Enrolled
Jia Li, PhDPrincipal InvestigatorThe University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation

Media Library

High-GI Diet Clinical Trial Eligibility Overview. Trial Name: NCT05334342 — N/A
Spinal Cord Injury Research Study Groups: Low-GI Diet, High-GI Diet
Spinal Cord Injury Clinical Trial 2023: High-GI Diet Highlights & Side Effects. Trial Name: NCT05334342 — N/A
High-GI Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334342 — N/A
~3 spots leftby May 2025
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