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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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 groups in NCT03595943
Study groupRoleWhat they receive
Low glycemic index dietExperimentalLow glycemic index pulse-based diet (i.e. beans, peas, lentils, chickpeas)
Receives: Dietary Supplement: Low glycemic index, pulse-based diet
Regular hospital dietActive comparatorModerate 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.

  1. 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)
  1. Insulin area under the curve

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

    Measured: Change from baseline to 4 days

  2. Fasting glucose

    Fasting glucose from serum

    Measured: Change from baseline to 4 days

  3. Fasting insulin

    Fasting Insulin from serum

    Measured: Change from baseline to 4 days

  4. Fasting cholesterol

    Fasting cholesterol from serum

    Measured: Change from baseline to 4 days

  5. Fasting LDL-cholesterol

    Fasting LDL-cholesterol from serum

    Measured: Change from baseline to 4 days

  6. Fasting triglycerides

    Fasting triglycerides from serum

    Measured: Change from baseline to 4 days

  7. Fasting HDL-cholesterol

    Fasting HDL-cholesterol from serum

    Measured: Change from baseline to 4 days

  8. Bone resorption

    Urinary n-telopeptides

    Measured: Change from baseline to 4 days

  9. Lean tissue mass

    Lean tissue mass from dual energy X-ray absorptiometry scans

    Measured: Change from baseline to 4 days

  10. Fat mass

    Fat mass from dual energy X-ray absorptiometry scans

    Measured: Change from baseline to 4 days

  11. Systolic Blood pressure

    Beat-by-beat blood pressure measurement

    Measured: Change from baseline to 1, 2, 3, and 4 days

  12. Arterial stiffness

    Arterial stiffness assessed by tonometry

    Measured: Change from baseline to 1, 2, 3, and 4 days

  13. 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.

  1. First posted23 Jul 2018
  2. Study start15 Jul 2018
  3. Primary completion30 Oct 2018
  4. Study completion1 Dec 2018

Resources

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)
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

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.

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