NCT06486077

Metabolic Health 1: Power Line Evaluation; Effect Size Determination

Full Title: Metabolic Health 1: Power Line Evaluation; Effect Size Determination

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Nature's Sunshine Products, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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, 13.4% of adults (aged 20-74) in the United States were considered obese (BMI 30.0-39.9) and less than 1% of adults were considered severely obese (BMI 40.0 and above). By 2018 the number of obese adults had risen to 42.8% and severely obese adults had risen to 9.6% of the population . By 2030 it is estimated that 48.9% of adults will be considered obese and 24.2% 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 one's 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 (i.e. the Mediterranean diet or keto diet), changes in specific macronutrient consumption (i.e. 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.

Conditions

• Metabolic Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Power Line Program	Power Line program consisting of 4 nutritional supplements: a meal replacement shake, a vegetable based green drink, a vascular health product, and a pre-meal fiber supplement

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-08-26
• Completion: 2025-11-28
• First posted: 2024-07-03
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States