Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03013764
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2016-12-20
Brief Title:
Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Interaction Between Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Physical inactivity results in reductions in glucose tolerance and less sensitivity to insulin If this inactivity lasts long enough it can result in insulin resistance and type 2 diabetes A high protein diet can reduce elevated glucose levels in individuals with type 2 diabetes Thus the investigators are interested in establishing if during a period of inactivity if a diet modification can minimize the glucose changes normally observed with inactivity The objective of this project is to determine if short-term high protein HP feeding protects against the changes in glucose levels normally observed with physical inactivity The investigators will also examine measures of blood vessel function blood lipid and blood pressure
Twelve subjects will complete two 10 day study periods of reduced physical activity and will be studied before and after each of these study periods For their testing subjects will have the following measurements postprandial glucose responses to a mixed meal 24 h free living blood pressure control during acute physical inactivity blood lipids changes in body composition changes in circadian rhythm using skin temperature ibutton measurement of aerobic capacity VO2 max blood vessel responsiveness flow mediated dilation -FMD and changes in free living glucose levels continuous glucose monitoring system CGMS Subjects will complete two conditions high protein -HP vs normal protein - NP diets in a randomized cross-over design In the inactive phase subjects will reduce there steps to lt5000 stepsd while consuming either a HP or NP diet Completion of the study will take 8-10 weeks
Twelve subjects will complete two 10 day study periods of reduced physical activity and will be studied before and after each of these study periods For their testing subjects will have the following measurements postprandial glucose responses to a mixed meal 24 h free living blood pressure control during acute physical inactivity blood lipids changes in body composition changes in circadian rhythm using skin temperature ibutton measurement of aerobic capacity VO2 max blood vessel responsiveness flow mediated dilation -FMD and changes in free living glucose levels continuous glucose monitoring system CGMS Subjects will complete two conditions high protein -HP vs normal protein - NP diets in a randomized cross-over design In the inactive phase subjects will reduce there steps to lt5000 stepsd while consuming either a HP or NP diet Completion of the study will take 8-10 weeks
Detailed Description:
It is well known that insulin resistance increases the risk of cardiovascular disease and type 2 diabetes which substantially impact mortality and morbidity and presents a significant economic burden Energy restriction with or without exercise has been demonstrated to attenuatereverse the development of insulin resistance and reduce the risk of cardiovascular disease and type 2 diabetes Indeed accumulating evidence suggests that diets high in protein may possess additional protection against the development of insulin resistance during energy restriction Layman et al found that a high protein diet HP PRO 125 gd compared with an isocaloric high carbohydrate diet HCHO PRO 68 gd resulted in greater reductions in fasting glucose and 2 h postprandial insulin levels during 16 weeks of energy restriction in overweight women Similarly a hypocaloric high protein diet PRO 45 vs 20 21 d diet treatment increased glucose oxidation and improved insulin sensitivity compared to an isocaloric high carbohydrate diet during a euglycemic hyperinsulinemic clamp procedure In addition markers of inflammation β-cell function and postprandial glucose and insulin levels were improved in addition to increased resting energy expenditure after 6 months of hypocaloric HP compared with HCHO diet in premenopausal women independent of weight loss The increase in REE and improvement in adipose tissue function may be a potential mechanism by which HP diet improves β-cell function since NEFAs are lower which may reduce lipotoxicity on the pancreas
It is evident that physical inactivity highlighted from bed rest studies impairs glucose tolerance insulin sensitivity vascular function and muscle protein synthesis in both healthy and obese individuals This model of inactivity however is extreme and does not recapitulate the physical inactivity paradigm seen in the natural human environment Consequently a less extreme reduction in daily physical activity 10000 stepsd to 1500 stepsd results in significant reductions in insulin sensitivity glucose tolerance and insulin-stimulated muscle Akt phosphorylation suggesting that the impairments in insulin sensitivity and glucose tolerance precede changes in body composition A reduction in ambulatory activity is a highly valid and translatable model to study the role of inactivity on the development of metabolic disease as most individuals go through periods of inactivity and it has been shown that a reduction in daily steps decreases insulin sensitivity and increases visceral adiposity To date no study has tested the effects of diet composition on the perturbations of physical inactivity It is important to know if increasing protein intake mitigates the negative perturbations of reduced ambulatory activity
Thus the overall objective of this project is to determine the extent to which short-term high protein HP feeding may protect against the metabolic perturbations of physical inactivity ie PPG hyperinsulinemia and insulin sensitivity The investigators will also examine measures of vascular function and free living blood pressure in addition to lipemic responses ie FFAs triglycerides cholesterol and lipoproteins to determine if HP diet impacts vascular function and lipemic responses during short term physical inactivity
Trial Objectives and Purpose
The specific aims of this project include the following
Specific Aim 1 To determine if HP diet during a period of low physical activity will lower the insulin response to a meal and help to maintain insulin sensitivity and β-cell function during a laboratory based mixed meal test MMT with stable isotope tracers
Specific Aim 2 To determine if a HP diet during a period of low physical activity will maintain glycemic control measured by continuous glucose monitoring CGM in healthy recreationally active young individuals
It is evident that physical inactivity highlighted from bed rest studies impairs glucose tolerance insulin sensitivity vascular function and muscle protein synthesis in both healthy and obese individuals This model of inactivity however is extreme and does not recapitulate the physical inactivity paradigm seen in the natural human environment Consequently a less extreme reduction in daily physical activity 10000 stepsd to 1500 stepsd results in significant reductions in insulin sensitivity glucose tolerance and insulin-stimulated muscle Akt phosphorylation suggesting that the impairments in insulin sensitivity and glucose tolerance precede changes in body composition A reduction in ambulatory activity is a highly valid and translatable model to study the role of inactivity on the development of metabolic disease as most individuals go through periods of inactivity and it has been shown that a reduction in daily steps decreases insulin sensitivity and increases visceral adiposity To date no study has tested the effects of diet composition on the perturbations of physical inactivity It is important to know if increasing protein intake mitigates the negative perturbations of reduced ambulatory activity
Thus the overall objective of this project is to determine the extent to which short-term high protein HP feeding may protect against the metabolic perturbations of physical inactivity ie PPG hyperinsulinemia and insulin sensitivity The investigators will also examine measures of vascular function and free living blood pressure in addition to lipemic responses ie FFAs triglycerides cholesterol and lipoproteins to determine if HP diet impacts vascular function and lipemic responses during short term physical inactivity
Trial Objectives and Purpose
The specific aims of this project include the following
Specific Aim 1 To determine if HP diet during a period of low physical activity will lower the insulin response to a meal and help to maintain insulin sensitivity and β-cell function during a laboratory based mixed meal test MMT with stable isotope tracers
Specific Aim 2 To determine if a HP diet during a period of low physical activity will maintain glycemic control measured by continuous glucose monitoring CGM in healthy recreationally active young individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None