Glucose IntoleranceNCT03595943
A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
A study testing Low glycemic index, pulse-based diet and Moderate glycemic index hospital diet in people with Glucose Intolerance, run by University of Saskatchewan at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Low glycemic index, pulse-based diet and Moderate glycemic index hospital diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2018to 1 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
Who cannot join
- Diabetic
- Vegetarian
- Food allergies
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan (SK), S7N5B2
About this study
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.
Read the 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.
- Conditions
- Glucose Intolerance
- Being tested
- Low glycemic index, pulse-based diet, Moderate glycemic index hospital diet
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index, pulse-based dietDietary supplement
Diet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas)
Moderate glycemic index hospital dietDietary supplement
Diet that is derived from a regular hospital menu for patients
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index diet | Experimental | Low glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas) Receives: Dietary Supplement: Low glycemic index, pulse-based diet |
| Regular hospital diet | Active comparator | Moderate glycemic index diet based on hospital menus Receives: Dietary Supplement: Moderate glycemic index hospital diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose area under the curve
glucose area under the curve from 2-hour oral glucose tolerance test
Measured: Change from baseline to 4 days
Secondary outcomes (13)
Insulin area under the curve
Insulin area under the curve from 2-hour oral glucose tolerance test
Measured: Change from baseline to 4 days
Fasting glucose
Fasting glucose from serum
Measured: Change from baseline to 4 days
Fasting insulin
Fasting Insulin from serum
Measured: Change from baseline to 4 days
Fasting cholesterol
Fasting cholesterol from serum
Measured: Change from baseline to 4 days
Fasting LDL-cholesterol
Fasting LDL-cholesterol from serum
Measured: Change from baseline to 4 days
Fasting triglycerides
Fasting triglycerides from serum
Measured: Change from baseline to 4 days
Fasting HDL-cholesterol
Fasting HDL-cholesterol from serum
Measured: Change from baseline to 4 days
Bone resorption
Urinary n-telopeptides
Measured: Change from baseline to 4 days
Lean tissue mass
Lean tissue mass from dual energy X-ray absorptiometry scans
Measured: Change from baseline to 4 days
Fat mass
Fat mass from dual energy X-ray absorptiometry scans
Measured: Change from baseline to 4 days
Systolic Blood pressure
Beat-by-beat blood pressure measurement
Measured: Change from baseline to 1, 2, 3, and 4 days
Arterial stiffness
Arterial stiffness assessed by tonometry
Measured: Change from baseline to 1, 2, 3, and 4 days
Diastolic blood pressure
Beat-by-beat blood pressure measurement
Measured: Change from baseline to 1, 2, 3, and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start15 Jul 2018
- Primary completion30 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Royal University Hospital Foundation
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595943
- Sponsor's protocol ID
- 17-176
- Status last verified
- Dec 2018
- First submitted
- 27 Jun 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low Glycemic Index Diet for Prevention of Glucose Intolerance During Bed Rest
- ClinicalTrials.gov ID
- NCT03595943
- Acronym / sponsor ID
- 17-176
- Conditions
- Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Royal University Hospital Foundation
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 23 Jul 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index diet | Experimental | Dietary Supplement: Low glycemic index, pulse-based dietLow glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas) |
| Regular hospital diet | Active comparator | Dietary Supplement: Moderate glycemic index hospital dietModerate glycemic index diet based on hospital menus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (3 listed)
- Diabetic
- Vegetarian
- Food allergies
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 glycemic index, pulse-based dietDiet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas) | Dietary supplement | Low glycemic index diet |
| Moderate glycemic index hospital dietDiet that is derived from a regular hospital menu for patients | Dietary supplement | Regular hospital diet |
Primary outcome
Glucose area under the curve
Time frame: Change from baseline to 4 days
glucose area under the curve from 2-hour oral glucose tolerance test
13 secondary outcomes
Insulin area under the curve
Time frame: Change from baseline to 4 days
Fasting glucose
Time frame: Change from baseline to 4 days
Fasting insulin
Time frame: Change from baseline to 4 days
Fasting cholesterol
Time frame: Change from baseline to 4 days
Fasting LDL-cholesterol
Time frame: Change from baseline to 4 days
Fasting triglycerides
Time frame: Change from baseline to 4 days
Fasting HDL-cholesterol
Time frame: Change from baseline to 4 days
Bone resorption
Time frame: Change from baseline to 4 days
Lean tissue mass
Time frame: Change from baseline to 4 days
Fat mass
Time frame: Change from baseline to 4 days
Systolic Blood pressure
Time frame: Change from baseline to 1, 2, 3, and 4 days
Arterial stiffness
Time frame: Change from baseline to 1, 2, 3, and 4 days
Diastolic blood pressure
Time frame: Change from baseline to 1, 2, 3, and 4 days
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 12 Dec 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 glycemic index, pulse-based diet and Moderate glycemic index hospital diet in people with Glucose Intolerance, run by University of Saskatchewan at 1 site in Canada.
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 3 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 12 Dec 2018. 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 Canada. 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?
Glucose area under the curve (time frame: Change from baseline to 4 days). 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 12 Dec 2018.