Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486077
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Metabolic Health 1 Power Line Evaluation Effect Size Determination
Sponsor:
Natures Sunshine Products Inc
Organization:
Natures Sunshine Products Inc
Study Overview
Official Title:
Full Title Metabolic Health 1 Power Line Evaluation Effect Size Determination
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 primary goal of this study is to demonstrate the safety and tolerability of the Power Line program an integrated whole-food supplement system Secondarily it is desired to determine the effect size of this program on maintenance of markers of metabolic health with a particular emphasis on insulin sensitivity and dyslipidemia
Detailed Description:
From 1960-1962 134 of adults aged 20-74 in the United States were considered obese BMI 300-399 and less than 1 of adults were considered severely obese BMI 400 and above By 2018 the number of obese adults had risen to 428 and severely obese adults had risen to 96 of the population By 2030 it is estimated that 489 of adults will be considered obese and 242 of adults will be considered severely obese with severe obesity becoming the most common BMI category for women low-income adults and non-Hispanic black adults Metabolic syndrome diabetes heart disease and other non-communicable diseases are on the rise particularly among children women and the lower socioeconomic classes There is a strong correlation between diet particularly the increased consumption of highly processed foods and underconsumption of vegetables and poorer metabolic health outcomes While physical activity is known to be a major component of metabolic health improving ones diet even in the absence of increased physical activity can have an important impact on improving metabolic health
Metabolic health for the purpose of this study will be defined in terms of the 5 cardiovascular risk factors associated with metabolic syndrome The risk factors associated with metabolic syndrome are elevated fasting blood glucose level obesity as measured by waist circumference elevated triglycerides elevated blood pressure and low HDL cholesterol There is a process by which long-term lifestyle choices lead to reduced metabolic health then metabolic syndrome then other lifestyle diseases such as type II diabetes Poor food choices and lack of physical activity give rise to chronically elevated insulin levels a slow increase in insulin resistance and eventual insulin insensitivity and even the complete inability to produce insulin Throughout much of this decline in metabolic health the process is reversible by improving lifestyle choices
While there is significant literature that demonstrates the impact of diet on metabolic health the literature tends to focus on interventions that involve a change to a specific type of diet ie the Mediterranean diet or keto diet changes in specific macronutrient consumption ie increased protein consumption leading to improved body composition or the introduction of specific phytonutrients or botanical ingredients Moreover studies on dietary interventions for metabolic health particularly those that involve supplementation are often confounded with factors such as additional changes in diet or exercise level Based on the current literature it is possible to understand how specific macronutrients and micronutrients can potentially interact to support metabolic health but controlled study on a complete supplement system that utilizes the current literature as a foundation for its genesis is lacking
Metabolic health for the purpose of this study will be defined in terms of the 5 cardiovascular risk factors associated with metabolic syndrome The risk factors associated with metabolic syndrome are elevated fasting blood glucose level obesity as measured by waist circumference elevated triglycerides elevated blood pressure and low HDL cholesterol There is a process by which long-term lifestyle choices lead to reduced metabolic health then metabolic syndrome then other lifestyle diseases such as type II diabetes Poor food choices and lack of physical activity give rise to chronically elevated insulin levels a slow increase in insulin resistance and eventual insulin insensitivity and even the complete inability to produce insulin Throughout much of this decline in metabolic health the process is reversible by improving lifestyle choices
While there is significant literature that demonstrates the impact of diet on metabolic health the literature tends to focus on interventions that involve a change to a specific type of diet ie the Mediterranean diet or keto diet changes in specific macronutrient consumption ie increased protein consumption leading to improved body composition or the introduction of specific phytonutrients or botanical ingredients Moreover studies on dietary interventions for metabolic health particularly those that involve supplementation are often confounded with factors such as additional changes in diet or exercise level Based on the current literature it is possible to understand how specific macronutrients and micronutrients can potentially interact to support metabolic health but controlled study on a complete supplement system that utilizes the current literature as a foundation for its genesis is lacking
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