Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207841
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2017-06-27
Brief Title:
Low CarbohydrateHigh Protein Diet to Improve Metabolic Health
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Utilizing a Low-CarbohydrateHigh-Protein Diet to Improve Metabolic Health in Individuals With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2023-03
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:
Individuals with spinal cord injury SCI are living to ages when metabolic disorders are highly prevalent The combination of impaired glucose tolerance and insulin resistance can disrupt lipid metabolism and increase the risk of cardiovascular disease and diabetes and contribute to an accelerated aging process in the SCI population Feasible interventions to improve metabolic function in the chronic SCI are in great demand Compared to pharmacologic therapies dietary modification is a more cost-effective treatment option for reducing the risk of metabolic dysfunction that surprisingly has not been rigorously investigated in people with SCI Therefore in the present study the investigators will investigate the efficacy of an 8-week eucaloric a meal plan designed specifically to provide the exact amount of calories needed to maintain a given body weight LC-HP dietary intervention for improving metabolic function body composition gut bacteria composition and quality of life in individuals with SCI and impaired glucose tolerance or type 2 diabetes The investigators also aim to determine the association between changes in the composition of gut bacteria and improvements in metabolic function and the association between improvements in metabolic function and improvements in quality of life
Detailed Description:
Individuals with spinal cord injury SCI are living to ages when metabolic disorders are highly prevalent Due to the loss of mobility and severe skeletal muscle atrophy in individuals with SCI obesity impaired glucose tolerance and peripheral insulin resistance develop after injury The combination of impaired glucose tolerance and insulin resistance can disrupt lipid metabolism and increase the risk of cardiovascular disease and diabetes and contribute to an accelerated aging process in the SCI population Because of these trends the overall burden of health complications and their economic impact has increased for individuals with SCI often leading to a progressive decrease in their long-term quality of life Feasible interventions to improve metabolic function ie the way the body processes proteins carbohydrates and fats in foods in those with chronic SCI are in great demand Given that metabolic disorders severely compromise health outcomes and important domains of quality of life including participation in daily life and community living and employment outcomes targeted strategies to combat these morbidities are of paramount importance Compared to pharmacologic therapies dietary modification is a more cost-effective treatment option for reducing the risk of metabolic dysfunction that surprisingly has not been rigorously investigated in people with SCI Much like the general US population individuals with SCI consume far more fat and carbohydrate than recommended levels High fat high carbohydrate diets western diet have been associated with a higher prevalence of obesity and metabolic disease as well as negative adaptations in the diversity of gut bacteria increased levels of harmful bacteria and reduced levels of beneficial bacteria that usually precedes the development of diabetes or insulin resistance Therefore macronutrient carbohydrate protein and fat modification may be able to prevent or correct the impaired metabolic state in persons with SCI Diets composed of relatively high protein and low carbohydrate have been shown to improve body composition ie reduce body fat while maintaining lean tissue and metabolic profiles ie increase in insulin sensitivity and glucose tolerance in diabetic able bodied individuals who are obese or overweight This improvement is thought to be due to proteins i effect on the sensation of feeling full after eating food despite similar or lower energy intake ii contribution to storage of fat-free mass and iii insulin sensitizing effect
The investigators pilot work supports this hypothesis in that we showed that 8 weeks of a low carbohydratehigh-protein LC-HP diet significantly improved whole body insulin sensitivity WBIS and glucose tolerance and decreased the amount of intra-abdominal fat in six men with SCI and with either untreated type 2 diabetes or impaired glucose tolerance pre-diabetes In addition to significant improvements in metabolic health our pilot work also successfully demonstrated the safety and feasibility of our approach The lack of adverse effects and the improvement in glucose control and insulin sensitivity in our study participants with SCI prompted us to propose the current study involving both men and women in order to determine the effects of the dietary protocol to treat type 2 diabetes or impaired glucose tolerance in persons with chronic SCI Thus the investigators propose an investigation to determine if 8 weeks of an LCHP dietary intervention induces the physiological adaptations necessary to improve metabolic function and body composition and alter the diversity of gut bacteria in a large cohort of individuals with SCI The ultimate outcome of this project will be an effective diet program which can be easily and economically implemented at home as a non-pharmacological means of achieving blood glucose control for people with SCI and impaired glucose tolerance or untreated type 2 diabetes
The investigators pilot work supports this hypothesis in that we showed that 8 weeks of a low carbohydratehigh-protein LC-HP diet significantly improved whole body insulin sensitivity WBIS and glucose tolerance and decreased the amount of intra-abdominal fat in six men with SCI and with either untreated type 2 diabetes or impaired glucose tolerance pre-diabetes In addition to significant improvements in metabolic health our pilot work also successfully demonstrated the safety and feasibility of our approach The lack of adverse effects and the improvement in glucose control and insulin sensitivity in our study participants with SCI prompted us to propose the current study involving both men and women in order to determine the effects of the dietary protocol to treat type 2 diabetes or impaired glucose tolerance in persons with chronic SCI Thus the investigators propose an investigation to determine if 8 weeks of an LCHP dietary intervention induces the physiological adaptations necessary to improve metabolic function and body composition and alter the diversity of gut bacteria in a large cohort of individuals with SCI The ultimate outcome of this project will be an effective diet program which can be easily and economically implemented at home as a non-pharmacological means of achieving blood glucose control for people with SCI and impaired glucose tolerance or untreated type 2 diabetes
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