Low-GI Diet Vs High-GI Diet in Individuals with SCI

NCT05334342 | Completed

• 1 other identifier: IRB-300008930
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries; Postprandial Hypotension; Glucose Metabolism Disorders

Keywords

Spinal Cord Injury; Low glycemic index diet

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (6)

• Low-GI diet on postprandial glycemia- Visit 1

  In-Lab testing - Visit 1 - Day 1

• Low-GI diet on postprandial glycemia - Visit 2

  In-Lab testing - Visit 2 - Day 1

• Low-GI Diet on Postprandial Glucose Responses

  Free-living condition - Diet A - Day 2

• Low-GI Diet on Postprandial Glucose Responses

  Free-living condition - Diet A - Day 3

• Low-GI Diet on Postprandial Glucose Responses

  Free-living condition - Diet B - Day 2

Study Arms (2)

Low-GI Diet

EXPERIMENTAL

Low Glycemic Index Diet

Dietary Supplement: Low-GI Diet

High-GI Diet

ACTIVE COMPARATOR

High Glycemic Index Diet

Dietary Supplement: High-GI Diet

Interventions

Low-GI Diet DIETARY_SUPPLEMENT

Participants will be given a low glycemic index diet

Low-GI Diet

High-GI Diet DIETARY_SUPPLEMENT

Participants will be given a high glycemic index diet

High-GI Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jia Li, PhD

  The University of Alabama at Birmingham Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 19, 2022
• Study Start: July 5, 2023
• Primary Completion: August 10, 2023
• Study Completion: April 26, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)