An interventional study of Low-GI Diet and High-GI Diet in Spinal Cord Injuries, Postprandial Hypotension and Glucose Metabolism Disorders, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Ohio State University · Not applicable, Interventional, and Basic science
The purpose of this pilot research project is to examine the impact of a low-glycemic index (GI) diet on postprandial hypotension and glucose control in individuals with chronic spinal cord injury. The objectives are: 1) To evaluate the effect of the low-GI diet on the magnitude of postprandial systolic blood pressure drop compared to a high-GI control diet. 2)To evaluate the effect of a low-GI diet on postprandial glucose and insulin responses compared to a high-GI control diet.
Participants will first come for a screening visit one time, lasting a total of 2.5hours. For this screening visit, each participant will need to fast for 12 hours(go 12 hours without eating from the last meal). During this study visit, each participant will be going through the following tests:
After the screening visit, each participant will be coming for study visits on 2 separate mornings, separated by at least 1 week. On these two mornings, the participant will be randomly picked (like the flip of a coin) by a computer to eat the low-glycemic index meal or high-glycemic index meal. After the visit in the morning, the participant will be sent home wearing a blood pressure monitor and blood sugar monitor, along with study meals the participant will be eating for 3 days.
These procedures and tests will be made during these 3-day periods:
At UAB during the morning visit:
After participant goes home from UAB:
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Exclusion Criteria:
Low Glycemic Index Diet
Dietary Supplement: Low-GI Diet
High Glycemic Index Diet
Dietary Supplement: High-GI Diet
Participants will be given a low glycemic index diet
Participants will be given a high glycemic index diet
Post-meal Systolic Blood Pressure Change- Visit 1
SBP will be measured in the temperature-controlled, quiet, dimly lit room. Measurements will be taken using an automated sphygmomanometer every 5 minutes for 20 minutes before, and for 120 minutes after meal intake, with the participant in a sitting position. Investigators will identify the nadir of SBP during the 120-minute postprandial period. The magnitude of the drop in SBP will be calculated by subtracting the nadir value from the resting baseline average value.
Time frame: In-lab testing - Visit 1 - Day 1
Post-meal Systolic Blood Pressure Change- Visit 2
SBP will be measured in the temperature-controlled, quiet, dimly lit room. Measurements will be taken using an automated sphygmomanometer every 5 minutes for 20 minutes before, and for 120 minutes after meal intake, with the participant in a sitting position. Investigators will identify the nadir of SBP during the 120-minute postprandial period. The magnitude of the drop in SBP will be calculated by subtracting the nadir value from the resting baseline average value.
Time frame: In-lab testing - Visit 2 - Day 1
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 1
After the in-lab meal test, each participant will be fitted with an ambulatory blood pressure (ABP) monitoring (ABPM) device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. Each participant's ABP will be monitored for a total of 3 days. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet A - Day 1
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 2
After the in-lab meal test, each participant will be fitted with an ABPM device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet A - Day 2
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 3
After the in-lab meal test, each participant will be fitted with an ABPM device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet A - Day 3
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 1
After the in-lab meal test, each participant will be fitted with an ABPM device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet B - Day 1
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 2
After the in-lab meal test, each participant will be fitted with an ABPM device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet B - Day 2
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 3
After the in-lab meal test, each participant will be fitted with an ABPM device, the Spacelabs OnTrak device, which has been validated for use in assessing ABP. The first measurement will be obtained at UAB to ensure proper function of the device. The monitors will be programmed to measure BP at 15-minute intervals during the daytime (while participants are awake, e.g., 6 am to 11 pm). Participants will be instructed to keep the monitored arm steady and at heart level during each BP reading. Investigators will utilize the menu checklist to identify the timing of each meal consumed. The magnitude of the PPH will be calculated for each meal, by substracting the nadir of SBP within 2 hours after each meal from the average SBP before each meal.
Time frame: Free-living condition - Diet B - Day 3
Low-GI diet on postprandial glycemia- Visit 1
The investigators will obtain blood samples to assess blood sugar and insulin responses to the study diet throughout the in-lab testing period. An intravenous catheter will be in an antecubital vein for blood draws 10 minutes before and 10, 30, 60, 90, and 120 minutes after meal consumption.
Time frame: In-Lab testing - Visit 1 - Day 1
Low-GI diet on postprandial glycemia - Visit 2
The investigators will obtain blood samples to assess blood sugar and insulin responses to the study diet throughout the in-lab testing period. An intravenous catheter will be in an antecubital vein for blood draws 10 minutes before and 10, 30, 60, 90, and 120 minutes after meal consumption.
Time frame: In-Lab testing - Visit 2 - Day 1
Low-GI Diet on Postprandial Glucose Responses
After the standard lab meal test, an FDA-approved CGM device (Dexcom G6 Pro, Dexcom, Inc.) will be placed in the back of each participant's arm to automatically measure glucose every 5 minutes during the 3-day study period. Postprandial peak glucose concentration and glucose area under the curve within 2 hours after each meal will be identified and calculated (mealtime will be recorded on the menu checklist by each participant or their caregiver).
Time frame: Free-living condition - Diet A - Day 2
Low-GI Diet on Postprandial Glucose Responses
After the standard lab meal test, an FDA-approved CGM device (Dexcom G6 Pro, Dexcom, Inc.) will be placed in the back of each participant's arm to automatically measure glucose every 5 minutes during the 3-day study period. Postprandial peak glucose concentration and glucose area under the curve within 2 hours after each meal will be identified and calculated (mealtime will be recorded on the menu checklist by each participant or their caregiver).
Time frame: Free-living condition - Diet A - Day 3
Low-GI Diet on Postprandial Glucose Responses
After the standard lab meal test, an FDA-approved CGM device (Dexcom G6 Pro, Dexcom, Inc.) will be placed in the back of each participant's arm to automatically measure glucose every 5 minutes during the 3-day study period. Postprandial peak glucose concentration and glucose area under the curve within 2 hours after each meal will be identified and calculated (mealtime will be recorded on the menu checklist by each participant or their caregiver).
Time frame: Free-living condition - Diet B - Day 2
Low-GI Diet on Postprandial Glucose Responses
After the standard lab meal test, an FDA-approved CGM device (Dexcom G6 Pro, Dexcom, Inc.) will be placed in the back of each participant's arm to automatically measure glucose every 5 minutes during the 3-day study period. Postprandial peak glucose concentration and glucose area under the curve within 2 hours after each meal will be identified and calculated (mealtime will be recorded on the menu checklist by each participant or their caregiver).
Time frame: Free-living condition - Diet B - Day 3
Plan to share: No — IPD will not be shared with other researchers that are not on the study.
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