Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03565510
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2018-06-11
Brief Title:
The Impact of a High-protein Diet on Energy Metabolism in Healthy Men
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
A Randomized Controlled Cross-over Trial Investigating the Impact of a High-protein Diet on Energy Metabolism in Healthy Men
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the impact of a high-protein diet achieved with the use of a nutritional supplement Almased versus a diet of a typical North American macronutrient distribution on energy metabolism metabolic blood markers and appetite sensations
This study will be a randomized controlled cross-over trial of an acute nutritional intervention A total of 20 participants will be randomly assigned 11 to one of the following groups
Control group CON
High protein diet group HP
The diets given to participants in both groups will be eucaloric
While receiving the diets in the whole body calorimetry unit for 32 hours participants overall changes in energy metabolism metabolic blood markers and appetite sensations will be assessed
This study will be a randomized controlled cross-over trial of an acute nutritional intervention A total of 20 participants will be randomly assigned 11 to one of the following groups
Control group CON
High protein diet group HP
The diets given to participants in both groups will be eucaloric
While receiving the diets in the whole body calorimetry unit for 32 hours participants overall changes in energy metabolism metabolic blood markers and appetite sensations will be assessed
Detailed Description:
This study will be a randomized controlled cross-over trial of an acute nutritional intervention The participants will be randomly assigned 11 to one of the following groups
Control group CON Those assigned to the CON will receive a diet composed of 55 of carbohydrate 15 of protein and 30 of lipid similar to the North American dietary pattern 3
High protein diet group HP Those assigned to the HP will receive a diet composed of 35 of carbohydrate 40 of protein and 25 of lipid constructed around a soy protein-based meal replacement Almased
The diets given to participants in both groups will be eucaloric
The following metabolic changes will be assessed between the diets
Energy metabolism energy expenditure and substrate oxidation
Metabolic blood markers glucose insulin lipid panel peptide tyrosine-tyrosine PYY glucagon-like peptide-1 GLP-1 ghrelin leptin free glycerol and free fatty acids
Appetite sensations hunger satiety fullness and prospective food consumption
Sample Size A total of 18 participants will be able to detect an effect size of 141 The effect size was calculated based on changes in RQ 090 004 in control group and 085 003 in a high protein group from a previously published study Accounting for a 20 attrition rate formula N181-20 the total sample size of 23 participants will have a power of 80 with a significance level of 5 The sample size calculation was done using GPower version 3192
Visit 1 - Screening Visit During the screening visit the study coordinator will run through the study protocol and obtain written informed consent as well as participants contact information Eligibility to participate in the study will be based on set inclusion and exclusion criteria completion of physical activity questionnaires anthropometric assessment bioelectrical impedance analysis BIA and analysis of biomarkers for kidney and liver function electrolyte status and thyroid-stimulating hormone
Visit 2 - Orientation Visit During the orientation visit participants will answer questions related to their health status and food preferences will have their energy requirements assessed by an 1-hour WBCU test and will be provided an explanation about the run-in diet period Body composition will also be assessed using dual energy X-ray absorptiometry DXA and air displacement plethysmography ADP
Visits 3 5 - Fitness Test Run-In Diet Visit To standardize the exercise intensity while in the WBCU participants will attend a fitness test visit prior to their first WBCU test visit They will perform a submaximal exercise test on a treadmill Freemotion Incline Trainer The exercise test will begin at an individualized walking speed characterized as comfortable and sustainable The incline will increase by 2 every three minutes until a RER of 09 has been achieved During exercise expired gases will be analyzed by a calibrated TrueMax metabolic measurement system ParvoMedics Sandy UT To reproduce the same conditions during the WBCU exercise session a breakfast identical to that provided inside the WBCU CON Group will be given to participants at 9 am and the treadmill test will start at 1020 am To determine the workload for the WBCU exercise session each participants respiratory exchange ratio RER will be plotted against their fitness test workload The workload at which an RER of 085 occurred will be selected as the workload for the WBCU We anticipate there will be a RER of 085 003 during the WBCU control exercise session The small difference may be due to factors such as the change in substrate oxidation throughout a 40-minute bout of exercise
After the fitness test participants will receive all the meals necessary to complete the 3-day run-in diet This will standardize dietary intake among participants and minimize the effects of any eating stylebehaviours on baseline data The run-in diet will be a eucaloric diet and will have the same macronutrient distribution as of CON group diet 55 of carbohydrate 15 of protein and 30 of lipid During this three-day run-in diet period participants will be asked to abstain from any strenuous exercise including endurance andor resistance exercises They can exercise moderate and drink coffee during the first and second days of run-in diet but not during the third day
Visits 4 6 - Whole Body Calorimetry Test Visits Participants will complete a WBCU test visit twice during the study period which will occur after the run-in diet periods These visits will consist of two 32 hours 15 days energy expenditure assessments inside the WBCU During the 32-hour measurement period participants of both groups CON and HP will be provided with a five-meal diet breakfast lunch dinner and two snacks through an air-lock drawer system The CON group will receive a diet composed of 55 of carbohydrate 15 of protein and 30 of lipid The participants will receive breakfast lunch dinner and two snacks afternoon and evening The HP group will receive a diet composed of 35 of carbohydrate 40 of protein and 25 of lipid constructed around a soy protein-based meal replacement Almased Participants will consume approximately 1 gram of Almased per kg of body weight mixed with olive oil and low-fat milk 1 fat in their breakfast lunch and dinner Two snacks afternoon and evening composed of approximately 1 gram of Almased per kg of body weight mixed with apple juice and olive oil will also be provided Amounts of low-fat milk olive oil and apple juice will be adjusted on an individual basis in order to achieve the desired macronutrient composition for the HP group A variation of 2 for each macronutrient and 50 kcalday will be considered
The exercise session will be performed on the first morning from 1020 am to 1100 am spent in the WBCU The session will be performed on a treadmill BH T10 Pro Treadmill The speed and grade of the treadmill will be set based on the fitness test as previously described
Blood samples will be taken four times while participants are in the WBCU
Fasting on the first day at 0745 am
After the exercise session on the first day at 1100 am
Two hours postprandial on the first day at 0230 pm
Fasting on the second day at 0830 am The following blood markers will be analysed glucose insulin lipid panel PYY GLP-1 ghrelin leptin free glycerol and free-fatty acid While participants are inside the WBCU urine must be collected during the entire time This is necessary to determine total nitrogen excretion protein used by participants body during the test day Participants will be asked to rate their appetite sensations on a 100-mm visual analogue scale VAS immediately before and 30 minutes after each meal and snack provided in the WBCU in order to measure subjective appetite sensations hunger satiety fullness and prospective food consumption Participants will be asked to wear an accelerometer around the wrist during sleep The motion sensor will measure participants activity patterns during sleep A two week wash-out period between the WBCU test visits is needed to reduce the carryover effects of the interventions A two week washout period is typical of feeding trials with soy isoflavone intervention 4 5
Statistical Analyses Data distributions will be evaluated by the Shapiro-Wilk W-test Parametric variables will be expressed in average and standard deviation and then converted into delta scores ie post-pre values To determine the differences among the variables analyzed after the intervention within and between CON and HP groups between Students t-test or Mann-Whitney tests will be applied according to data distribution Pearsons correlation coefficients will be determined to assess whether there is a statistically significant correlation among the variables All analyses will be performed using SPSS version 220 considering a critical significance value of 5
Control group CON Those assigned to the CON will receive a diet composed of 55 of carbohydrate 15 of protein and 30 of lipid similar to the North American dietary pattern 3
High protein diet group HP Those assigned to the HP will receive a diet composed of 35 of carbohydrate 40 of protein and 25 of lipid constructed around a soy protein-based meal replacement Almased
The diets given to participants in both groups will be eucaloric
The following metabolic changes will be assessed between the diets
Energy metabolism energy expenditure and substrate oxidation
Metabolic blood markers glucose insulin lipid panel peptide tyrosine-tyrosine PYY glucagon-like peptide-1 GLP-1 ghrelin leptin free glycerol and free fatty acids
Appetite sensations hunger satiety fullness and prospective food consumption
Sample Size A total of 18 participants will be able to detect an effect size of 141 The effect size was calculated based on changes in RQ 090 004 in control group and 085 003 in a high protein group from a previously published study Accounting for a 20 attrition rate formula N181-20 the total sample size of 23 participants will have a power of 80 with a significance level of 5 The sample size calculation was done using GPower version 3192
Visit 1 - Screening Visit During the screening visit the study coordinator will run through the study protocol and obtain written informed consent as well as participants contact information Eligibility to participate in the study will be based on set inclusion and exclusion criteria completion of physical activity questionnaires anthropometric assessment bioelectrical impedance analysis BIA and analysis of biomarkers for kidney and liver function electrolyte status and thyroid-stimulating hormone
Visit 2 - Orientation Visit During the orientation visit participants will answer questions related to their health status and food preferences will have their energy requirements assessed by an 1-hour WBCU test and will be provided an explanation about the run-in diet period Body composition will also be assessed using dual energy X-ray absorptiometry DXA and air displacement plethysmography ADP
Visits 3 5 - Fitness Test Run-In Diet Visit To standardize the exercise intensity while in the WBCU participants will attend a fitness test visit prior to their first WBCU test visit They will perform a submaximal exercise test on a treadmill Freemotion Incline Trainer The exercise test will begin at an individualized walking speed characterized as comfortable and sustainable The incline will increase by 2 every three minutes until a RER of 09 has been achieved During exercise expired gases will be analyzed by a calibrated TrueMax metabolic measurement system ParvoMedics Sandy UT To reproduce the same conditions during the WBCU exercise session a breakfast identical to that provided inside the WBCU CON Group will be given to participants at 9 am and the treadmill test will start at 1020 am To determine the workload for the WBCU exercise session each participants respiratory exchange ratio RER will be plotted against their fitness test workload The workload at which an RER of 085 occurred will be selected as the workload for the WBCU We anticipate there will be a RER of 085 003 during the WBCU control exercise session The small difference may be due to factors such as the change in substrate oxidation throughout a 40-minute bout of exercise
After the fitness test participants will receive all the meals necessary to complete the 3-day run-in diet This will standardize dietary intake among participants and minimize the effects of any eating stylebehaviours on baseline data The run-in diet will be a eucaloric diet and will have the same macronutrient distribution as of CON group diet 55 of carbohydrate 15 of protein and 30 of lipid During this three-day run-in diet period participants will be asked to abstain from any strenuous exercise including endurance andor resistance exercises They can exercise moderate and drink coffee during the first and second days of run-in diet but not during the third day
Visits 4 6 - Whole Body Calorimetry Test Visits Participants will complete a WBCU test visit twice during the study period which will occur after the run-in diet periods These visits will consist of two 32 hours 15 days energy expenditure assessments inside the WBCU During the 32-hour measurement period participants of both groups CON and HP will be provided with a five-meal diet breakfast lunch dinner and two snacks through an air-lock drawer system The CON group will receive a diet composed of 55 of carbohydrate 15 of protein and 30 of lipid The participants will receive breakfast lunch dinner and two snacks afternoon and evening The HP group will receive a diet composed of 35 of carbohydrate 40 of protein and 25 of lipid constructed around a soy protein-based meal replacement Almased Participants will consume approximately 1 gram of Almased per kg of body weight mixed with olive oil and low-fat milk 1 fat in their breakfast lunch and dinner Two snacks afternoon and evening composed of approximately 1 gram of Almased per kg of body weight mixed with apple juice and olive oil will also be provided Amounts of low-fat milk olive oil and apple juice will be adjusted on an individual basis in order to achieve the desired macronutrient composition for the HP group A variation of 2 for each macronutrient and 50 kcalday will be considered
The exercise session will be performed on the first morning from 1020 am to 1100 am spent in the WBCU The session will be performed on a treadmill BH T10 Pro Treadmill The speed and grade of the treadmill will be set based on the fitness test as previously described
Blood samples will be taken four times while participants are in the WBCU
Fasting on the first day at 0745 am
After the exercise session on the first day at 1100 am
Two hours postprandial on the first day at 0230 pm
Fasting on the second day at 0830 am The following blood markers will be analysed glucose insulin lipid panel PYY GLP-1 ghrelin leptin free glycerol and free-fatty acid While participants are inside the WBCU urine must be collected during the entire time This is necessary to determine total nitrogen excretion protein used by participants body during the test day Participants will be asked to rate their appetite sensations on a 100-mm visual analogue scale VAS immediately before and 30 minutes after each meal and snack provided in the WBCU in order to measure subjective appetite sensations hunger satiety fullness and prospective food consumption Participants will be asked to wear an accelerometer around the wrist during sleep The motion sensor will measure participants activity patterns during sleep A two week wash-out period between the WBCU test visits is needed to reduce the carryover effects of the interventions A two week washout period is typical of feeding trials with soy isoflavone intervention 4 5
Statistical Analyses Data distributions will be evaluated by the Shapiro-Wilk W-test Parametric variables will be expressed in average and standard deviation and then converted into delta scores ie post-pre values To determine the differences among the variables analyzed after the intervention within and between CON and HP groups between Students t-test or Mann-Whitney tests will be applied according to data distribution Pearsons correlation coefficients will be determined to assess whether there is a statistically significant correlation among the variables All analyses will be performed using SPSS version 220 considering a critical significance value of 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None