Spinal Cord InjuriesNCT05334342
Low-GI Diet Vs High-GI Diet in Individuals with SCI
A study testing Low-GI Diet and High-GI Diet in people with Spinal Cord Injuries and Postprandial Hypotension, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Postprandial Hypotension, Glucose Metabolism Disorders
- What is being tested?
- Low-GI Diet and High-GI Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy or breastfeeding, type 1 or insulin-dependent type 2 diabetes, a recent change in the use of any medications, previous diagnosis of heart diseases and/or stroke, or neurological impairment other than SCI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Two Birds with One Stone: Impact of a Low Glycemic Index Diet on Postprandial Hypotension and Glucose Metabolism in Individuals with Spinal Cord Injury
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.
Read the detailed description
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:
- Urine pregnancy tests (for females)
- Medical History Questionnaire: It will take about 10 minutes, and participants will fill out a 1-page questionnaire about their medical history and medication use
- Each participant will consume a semi-liquid meal within 5 minutes
- Each participant's blood pressure will be measured every 5 minutes before eating, for 15 minutes, and for 2 hours after eating.
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:
- Meal tolerance test: Firstly, a nurse will place an intravenous catheter in the participant's arm to allow blood draws. The participant will be asked to eat the study meal given by the investigators, and provide several blood samples (immediately before and 10, 30, 60, 90, and 120 minutes after glucose ingestion). The total amount of blood taken will be about 3 tablespoons.
- Participant's blood pressure will be measured every 5 minutes before eating, for 15 minutes, and for 2 hours after eating.
After participant goes home from UAB:
- Before the participant leaves for home, the investigator(s) will fit a wearable blood pressure monitor on his/her arm and insert a continuous glucose monitor in the back of the other arm.
- The blood pressure monitors will be programmed to measure blood pressure every 15 minutes during the daytime and hourly during nighttime. The daytime and nighttime cycle will be set according to each participant's sleep/wake pattern. Participants will need to keep the monitored arm steady and at heart level during each blood pressure reading.
- Each participant will be provided with meals for 3 days. They will be eating all and only the meals the investigators provide during these 3 days.
- Each participant will be filling out a checklist to record the time of each meal consumed.
- Each participant will be asked questions regarding their daily activity for the past 3 days for the investigators to estimate their activity level. The investigators will use the Physical Activity Recall Assessment for People with Spinal Cord Injury (PARA-SCI) questionnaire. This takes about 30 minutes and will be done over the phone
- Being tested
- Low-GI Diet, High-GI Diet
- Keywords
- Spinal Cord Injury, Low glycemic index diet
- Medical subject headings
- Spinal Cord Injuries, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-GI DietDietary supplement
Participants will be given a low glycemic index diet
High-GI DietDietary supplement
Participants will be given a high glycemic index diet
| Study group | Role | What they receive |
|---|---|---|
| Low-GI Diet | Experimental | Low Glycemic Index Diet Receives: Dietary Supplement: Low-GI Diet |
| High-GI Diet | Active comparator | High Glycemic Index Diet Receives: Dietary Supplement: High-GI Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Free-living condition - Diet B - Day 3
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Free-living condition - Diet B - Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start5 Jul 2023
- Primary completion10 Aug 2023
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Li, Ohio State University
- Investigators
- Jia Li, PhD, Principal investigator, The University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334342
- Sponsor's protocol ID
- IRB-300008930
- Status last verified
- Oct 2024
- First submitted
- 21 Mar 2022
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers that are not on the study.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Birds with One Stone: Impact of a Low Glycemic Index Diet on Postprandial Hypotension and Glucose Metabolism in Individuals with Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05334342
- Acronym / sponsor ID
- IRB-300008930
- Keywords
- Spinal Cord Injury, Low glycemic index diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Urine pregnancy tests (for females)
- Medical History Questionnaire: It will take about 10 minutes, and participants will fill out a 1-page questionnaire about their medical history and medication use
- Each participant will consume a semi-liquid meal within 5 minutes
- Each participant's blood pressure will be measured every 5 minutes before eating, for 15 minutes, and for 2 hours after eating.
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:
- Meal tolerance test: Firstly, a nurse will place an intravenous catheter in the participant's arm to allow blood draws. The participant will be asked to eat the study meal given by the investigators, and provide several blood samples (immediately before and 10, 30, 60, 90, and 120 minutes after glucose ingestion). The total amount of blood taken will be about 3 tablespoons.
- Participant's blood pressure will be measured every 5 minutes before eating, for 15 minutes, and for 2 hours after eating.
After participant goes home from UAB:
- Before the participant leaves for home, the investigator(s) will fit a wearable blood pressure monitor on his/her arm and insert a continuous glucose monitor in the back of the other arm.
- The blood pressure monitors will be programmed to measure blood pressure every 15 minutes during the daytime and hourly during nighttime. The daytime and nighttime cycle will be set according to each participant's sleep/wake pattern. Participants will need to keep the monitored arm steady and at heart level during each blood pressure reading.
- Each participant will be provided with meals for 3 days. They will be eating all and only the meals the investigators provide during these 3 days.
- Each participant will be filling out a checklist to record the time of each meal consumed.
- Each participant will be asked questions regarding their daily activity for the past 3 days for the investigators to estimate their activity level. The investigators will use the Physical Activity Recall Assessment for People with Spinal Cord Injury (PARA-SCI) questionnaire. This takes about 30 minutes and will be done over the phone
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-GI Diet | Experimental | Dietary Supplement: Low-GI DietLow Glycemic Index Diet |
| High-GI Diet | Active comparator | Dietary Supplement: High-GI DietHigh Glycemic Index Diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- pregnancy or breastfeeding, type 1 or insulin-dependent type 2 diabetes, a recent change in the use of any medications, previous diagnosis of heart diseases and/or stroke, or neurological impairment other than SCI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-GI DietParticipants will be given a low glycemic index diet | Dietary supplement | Low-GI Diet |
| High-GI DietParticipants will be given a high glycemic index diet | Dietary supplement | High-GI Diet |
Primary outcome
Post-meal Systolic Blood Pressure Change- Visit 1
Time frame: In-lab testing - Visit 1 - Day 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.
Post-meal Systolic Blood Pressure Change- Visit 2
Time frame: In-lab testing - Visit 2 - Day 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 1
Time frame: Free-living condition - 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 2
Time frame: Free-living condition - 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet A- Day 3
Time frame: Free-living condition - 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 1
Time frame: Free-living condition - 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 2
Time frame: Free-living condition - 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.
Low-GI Diet on Post-meal Systolic Blood Pressure Change- Diet B- Day 3
Time frame: Free-living condition - 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.
6 secondary outcomes
Low-GI diet on postprandial glycemia- Visit 1
Time frame: In-Lab testing - Visit 1 - Day 1
Low-GI diet on postprandial glycemia - Visit 2
Time frame: In-Lab testing - Visit 2 - Day 1
Low-GI Diet on Postprandial Glucose Responses
Time frame: Free-living condition - Diet A - Day 2
Low-GI Diet on Postprandial Glucose Responses
Time frame: Free-living condition - Diet A - Day 3
Low-GI Diet on Postprandial Glucose Responses
Time frame: Free-living condition - Diet B - Day 2
Low-GI Diet on Postprandial Glucose Responses
Time frame: Free-living condition - Diet B - Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers that are not on the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Li, PhD principal investigator
The University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-GI Diet and High-GI Diet in people with Spinal Cord Injuries and Postprandial Hypotension, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-meal Systolic Blood Pressure Change- Visit 1 (time frame: In-lab testing - Visit 1 - Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.