Diet and Exercise Solutions to Postprandial Hypotension

April 22, 2026 updated by: Ceren Yarar-Fisher, Ohio State University

Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury

The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
  • AIS A or B
  • >1-year post-injury

Exclusion Criteria:

  • Currently pregnant of breast-feeding
  • Type 1 or 2 diabetes
  • Previous gut augmentation bariatric surgery
  • Neurological impairment other than SCI
  • History of uncontrolled autonomic dysreflexia
  • History of bone fractures
  • Use of abdominal binder or anti-hypotensive drugs
  • Fitted with pacemaker or defibrillator
  • Currently receiving electrical stimulation training or in the previous year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Stimulation
Other: High glycemic load diet
High glycemic load diet
Other: Electrical stimulation exercise
Lower-body electrical stimulation exercise for 1-h after eating
Placebo Comparator: High glycemic load
Other: High glycemic load diet
High glycemic load diet
Experimental: Low glycemic load
Other: Low glycemic load
Low glycemic load diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of systolic blood pressure decrease (in-lab)
Time Frame: Visit 2-4, Day 1
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast and lunch under laboratory-controlled conditions
Visit 2-4, Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of systolic blood pressure decrease (at-home)
Time Frame: Visits 2-4, Days 1-3
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast, lunch, and dinner for 3-days during at-home testing
Visits 2-4, Days 1-3
Postprandial glucose (in-lab)
Time Frame: Visits 2-4, Day 1
Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Visits 2-4, Day 1
Postprandial insulin (in-lab)
Time Frame: Visits 2-4, Day 1
Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Visits 2-4, Day 1
Postprandial glucose (at-home)
Time Frame: Visits 2-4, Day 1-3
A continuous glucose monitor will be used to measure glucose for 2-h after breakfast, lunch, and dinner for 3-days during at-home testing
Visits 2-4, Day 1-3
Blood flow (in-lab)
Time Frame: Visits 2-4, Day 1
Blood flow at the radial, brachial, popliteal and superior mesenteric arteries will be obtained using Doppler imaging at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Visits 2-4, Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024H0147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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