A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest

NCT03595943 | Completed

• 1 other identifier: 17-176
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Recovery from surgery, injury or illness might require periods of bed rest in-hospital or at home. Bed rest may be needed for recovery but also has negative consequences. Prolonged bed rest reduces the ability of muscle to take up sugar from the blood, and increases blood levels of sugar and fat which may actually delay recovery. Bone starts breaking down when there is very little skeletal stimulation or 'stress' that typically occurs with walking. Bed rest stiffens arteries which may increase blood pressure. Different diets may influence the extent of harmful effects to muscle, bone and arteries during bed rest. This study compares a diet with increased plant sources (i.e. lentils, chickpeas, beans and peas) to a typical hospital diet (mostly animal sources and foods high in refined sugar) on blood, arteries, muscle and bone during bed rest. The investigators will test six healthy adults before, during and after two periods of 4-day bed rest, one when they eat a typical hospital diet, one with a diet containing more plant sources. The investigators will learn more about the effects of diet during bed rest and be able to make recommendations about diets to help ensure healthy recovery for individuals requiring bed rest.

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• Glucose area under the curve

  glucose area under the curve from 2-hour oral glucose tolerance test

  Change from baseline to 4 days

Secondary Outcomes (13)

• Insulin area under the curve

  Change from baseline to 4 days

• Fasting glucose

  Change from baseline to 4 days

• Fasting insulin

  Change from baseline to 4 days

• Fasting cholesterol

  Change from baseline to 4 days

• Fasting LDL-cholesterol

  Change from baseline to 4 days

Study Arms (2)

Low glycemic index diet

EXPERIMENTAL

Low glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas)

Dietary Supplement: Low glycemic index, pulse-based diet

Regular hospital diet

ACTIVE COMPARATOR

Moderate glycemic index diet based on hospital menus

Dietary Supplement: Moderate glycemic index hospital diet

Interventions

Low glycemic index, pulse-based diet DIETARY_SUPPLEMENT

Diet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas)

Low glycemic index diet

Moderate glycemic index hospital diet DIETARY_SUPPLEMENT

Diet that is derived from a regular hospital menu for patients

Regular hospital diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy

You may not qualify if:

• Diabetic
• Vegetarian
• Food allergies

Sponsors & Collaborators

• University of Saskatchewan: lead
• Royal University Hospital Foundation: collaborator

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan (SK), S7N5B2, Canada

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 23, 2018
• Study Start: July 15, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)