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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595943
• Other study ID #: 17-176
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 1, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Diabetic

• Vegetarian

• Food allergies

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Dietary Supplement:
• Low glycemic index, pulse-based diet
Diet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas)
• Moderate glycemic index hospital diet
Diet that is derived from a regular hospital menu for patients

Locations

Country	Name	City	State
Canada	College of Kinesiology, University of Saskatchewan	Saskatoon	Saskatchewan (SK)

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Royal University Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose area under the curve	glucose area under the curve from 2-hour oral glucose tolerance test	Change from baseline to 4 days
Secondary	Insulin area under the curve	Insulin area under the curve from 2-hour oral glucose tolerance test	Change from baseline to 4 days
Secondary	Fasting glucose	Fasting glucose from serum	Change from baseline to 4 days
Secondary	Fasting insulin	Fasting Insulin from serum	Change from baseline to 4 days
Secondary	Fasting cholesterol	Fasting cholesterol from serum	Change from baseline to 4 days
Secondary	Fasting LDL-cholesterol	Fasting LDL-cholesterol from serum	Change from baseline to 4 days
Secondary	Fasting triglycerides	Fasting triglycerides from serum	Change from baseline to 4 days
Secondary	Fasting HDL-cholesterol	Fasting HDL-cholesterol from serum	Change from baseline to 4 days
Secondary	Bone resorption	Urinary n-telopeptides	Change from baseline to 4 days
Secondary	Lean tissue mass	Lean tissue mass from dual energy X-ray absorptiometry scans	Change from baseline to 4 days
Secondary	Fat mass	Fat mass from dual energy X-ray absorptiometry scans	Change from baseline to 4 days
Secondary	Systolic Blood pressure	Beat-by-beat blood pressure measurement	Change from baseline to 1, 2, 3, and 4 days
Secondary	Arterial stiffness	Arterial stiffness assessed by tonometry	Change from baseline to 1, 2, 3, and 4 days
Secondary	Diastolic blood pressure	Beat-by-beat blood pressure measurement	Change from baseline to 1, 2, 3, and 4 days