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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-GI Diet | Experimental | Low Glycemic Index Diet |
|
| High-GI Diet | Active Comparator | High Glycemic Index Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-GI Diet | Dietary Supplement | Participants will be given a low glycemic index diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Free-living condition - Diet A - Day 1 |
| Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In-Lab testing - Visit 1 - Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jia Li, PhD | The University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
IPD will not be shared with other researchers that are not on the study.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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The investigator(s) propose to recruit 12 participants with chronic SCI (>1 year) and utilize a single-blinded randomized crossover design (low-GI vs. high-GI diet) to assess postprandial BP and postprandial glycemic responses to the study diets in this population.
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The random permuted blocks strategy will be used in this study to randomly allocate an equal number of participants into the two crossover arms by the study statistician. Diet group assignment will be coded (e.g., low-gi diet=diet a; high-gi diet=diet b). Only the kitchen staff preparing the meals will know the code. Study personnel analyzing the biological samples, entering data, and performing statistical analyses will be blinded to the diet group assignment to reduce bias. Due to the nature of dietary studies, participants will not be blinded to the randomization.
| High-GI Diet |
| Dietary Supplement |
Participants will be given a high glycemic index diet |
|
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. |
| 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. | 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. | 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. | 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. | Free-living condition - Diet B - Day 3 |
| 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. | 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). | 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). | 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). | 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). | Free-living condition - Diet B - Day 3 |
| D014947 | Wounds and Injuries |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |