A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
Primary Purpose
Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low glycemic index, pulse-based diet
Moderate glycemic index hospital diet
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance
Eligibility Criteria
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Diabetic
- Vegetarian
- Food allergies
Sites / Locations
- College of Kinesiology, University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low glycemic index diet
Regular hospital diet
Arm Description
Low glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas)
Moderate glycemic index diet based on hospital menus
Outcomes
Primary Outcome Measures
Glucose area under the curve
glucose area under the curve from 2-hour oral glucose tolerance test
Secondary Outcome Measures
Insulin area under the curve
Insulin area under the curve from 2-hour oral glucose tolerance test
Fasting glucose
Fasting glucose from serum
Fasting insulin
Fasting Insulin from serum
Fasting cholesterol
Fasting cholesterol from serum
Fasting LDL-cholesterol
Fasting LDL-cholesterol from serum
Fasting triglycerides
Fasting triglycerides from serum
Fasting HDL-cholesterol
Fasting HDL-cholesterol from serum
Bone resorption
Urinary n-telopeptides
Lean tissue mass
Lean tissue mass from dual energy X-ray absorptiometry scans
Fat mass
Fat mass from dual energy X-ray absorptiometry scans
Systolic Blood pressure
Beat-by-beat blood pressure measurement
Arterial stiffness
Arterial stiffness assessed by tonometry
Diastolic blood pressure
Beat-by-beat blood pressure measurement
Full Information
NCT ID
NCT03595943
First Posted
June 27, 2018
Last Updated
December 10, 2018
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03595943
Brief Title
A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
Official Title
A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Many medical conditions and interventions require periods of bed rest in order to maximize recovery and restore optimal physical function. Unfortunately, muscle becomes glucose intolerant, bone starts to break down, and arteries become stiffer during sustained periods of chronic inactivity, such as bed rest. Elevation of blood glucose during hospital stays results in increased morbidity, mortality, length of stay and costs. Components of the typical Western diet (refined carbohydrates and protein from animal sources common in hospital foods) induce glucose intolerance, bone catabolism, and arterial stiffening; plant-based proteins may not have the same negative impact. Pulses (i.e. low fat legumes: lentils, chickpeas, beans, peas) contain carbohydrate with a low glycemic index, and do not substantially increase blood glucose levels. At the same time, they are high in protein, but do not contain the same sulphur-containing amino acid profile as animal proteins that induce bone resorption. Pulses are, therefore, a potential 'super food' to mitigate many of the negative impacts associated with required bed rest following medical illness.
The study purpose is to determine the effects of a pulse-based diet compared to a Western diet of typical hospital foods on glucose tolerance, bone catabolism, and arterial stiffening during bed rest. The investigators hypothesize that a pulse-based diet will be superior to a typical Western diet for preventing glucose intolerance, bone catabolism, and arterial stiffening during sustained bed rest.
Six healthy adults will take part in a cross-over study where they will be randomized to four days of bed rest while on a pulse-based or Western diet, have a one month wash-out and then cross-over before another four days of bed rest with the other diet. Immediately before and after bed rest (i.e. the first morning after the last night of bed rest), oral glucose tolerance tests will be conducted to assess glucose tolerance and insulin sensitivity (i.e. markers used to assess diabetes risk). At the same time points, fasting blood samples will be collected for lipid assessments. Urine will be collected for assessment of bone catabolism (via measures of N-telopeptides: a by-product of collagen from bone which appears in the urine when bone is breaking down). Blood pressure will be evaluated every two hours during bed rest days from 9am to 9pm. Arterial stiffness (measured by the gold-standard technique of pulse wave velocity using applanation tonometry) and beat-by-beat blood pressure will be used to assess blood vessel function before and after four days of bed rest.
This study will inform improved hospital diets and nutritional habits of patients to prevent or offset negative health implications during periods of bed rest that may be required either in-hospital, long-term care or at home as part of standard medical care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low glycemic index diet
Arm Type
Experimental
Arm Description
Low glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas)
Arm Title
Regular hospital diet
Arm Type
Active Comparator
Arm Description
Moderate glycemic index diet based on hospital menus
Intervention Type
Dietary Supplement
Intervention Name(s)
Low glycemic index, pulse-based diet
Intervention Description
Diet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas)
Intervention Type
Dietary Supplement
Intervention Name(s)
Moderate glycemic index hospital diet
Intervention Description
Diet that is derived from a regular hospital menu for patients
Primary Outcome Measure Information:
Title
Glucose area under the curve
Description
glucose area under the curve from 2-hour oral glucose tolerance test
Time Frame
Change from baseline to 4 days
Secondary Outcome Measure Information:
Title
Insulin area under the curve
Description
Insulin area under the curve from 2-hour oral glucose tolerance test
Time Frame
Change from baseline to 4 days
Title
Fasting glucose
Description
Fasting glucose from serum
Time Frame
Change from baseline to 4 days
Title
Fasting insulin
Description
Fasting Insulin from serum
Time Frame
Change from baseline to 4 days
Title
Fasting cholesterol
Description
Fasting cholesterol from serum
Time Frame
Change from baseline to 4 days
Title
Fasting LDL-cholesterol
Description
Fasting LDL-cholesterol from serum
Time Frame
Change from baseline to 4 days
Title
Fasting triglycerides
Description
Fasting triglycerides from serum
Time Frame
Change from baseline to 4 days
Title
Fasting HDL-cholesterol
Description
Fasting HDL-cholesterol from serum
Time Frame
Change from baseline to 4 days
Title
Bone resorption
Description
Urinary n-telopeptides
Time Frame
Change from baseline to 4 days
Title
Lean tissue mass
Description
Lean tissue mass from dual energy X-ray absorptiometry scans
Time Frame
Change from baseline to 4 days
Title
Fat mass
Description
Fat mass from dual energy X-ray absorptiometry scans
Time Frame
Change from baseline to 4 days
Title
Systolic Blood pressure
Description
Beat-by-beat blood pressure measurement
Time Frame
Change from baseline to 1, 2, 3, and 4 days
Title
Arterial stiffness
Description
Arterial stiffness assessed by tonometry
Time Frame
Change from baseline to 1, 2, 3, and 4 days
Title
Diastolic blood pressure
Description
Beat-by-beat blood pressure measurement
Time Frame
Change from baseline to 1, 2, 3, and 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Exclusion Criteria:
Diabetic
Vegetarian
Food allergies
Facility Information:
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan (SK)
ZIP/Postal Code
S7N5B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
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