Metabolic Health 1: Power Line Evaluation; Effect Size Determination

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Health
• Intervention / Treatment: Dietary supplement: Power Line Program

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Lehi, Utah, United States, 84043
      • The Hughes Center for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Generally healthy Female, Male and Non-Binary adults, 18-64 years of age (Inclusive)

Body Mass Index (BMI): 28.0-34.9 kilograms/meters2 (kg/m2) (Inclusive)

Preference given to individuals having a minimum of two of the following markers of metabolic imbalance: fasting blood glucose ≥ 100 milligrams/deciliter (mg/dl), serum triglycerides (TG) >100 mg/dl, serum high density lipoprotein - cholesterol (HDLc) (male sex < 40 mg/dl, female sex < 50 mg/dl), elevated blood pressure (systolic ≥ 120 and /or diastolic ≥ 80), elevated waist circumference (male sex ≥ 40 inches, female sex ≥ 35 inches)

Willing to maintain a consistent diet (including medications, vitamins, and supplements) and lifestyle routine throughout the study.

Willing to give written informed consent to participate in the Study.

Exclusion Criteria:

A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.

Allergies related to ingredients in study products

Known infection with HIV, TB or Hepatitis B or C.

POCBP: Not using effective contraception.

Blood Pressure medications or supplements

Diabetes medications or supplements

Cholesterol/Triglyceride lowering medications or supplements

Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the study products

Use of Narcotics during the last 30 days

Use of Anticoagulants during last 30 days

Use of Corticosteroids during the last 30 days

Use of controlled substances on a recreational basis during the last 30 days.

Consumption of more than 3 alcoholic beverages per day. One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor.

Inability to comply with Study and/or follow-up visits.

Any concurrent condition (including clinically significant abnormalities in medical history, physical examination, or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.

Any sound medical, psychiatric, and/or social reason which, in the opinion of the PI, would preclude safe participation in this Study or interfere with compliance.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Power Line Program; Daily supplementation with 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. Subjects will maintain their current lifestyle (specifically diet, exercise, and nutritional supplements) during intervention.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).	Data collection at individual study visits (Visit 1- baseline, Visit 2 - Day 30, and Visit 3 - Day 90) will be used to assess participants for supplementation program-related adverse events. Subjects with ongoing AEs may be followed until resolution at the discretion of the PI.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HDL-Cholesterol compared to baseline	HDL-Cholesterol will be measured at individual visits (visit 1- baseline, visit 3 - Day 60 and visit 4 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Number of participants with treatment-related changes in vital signs	Blood pressure, respiratory rate and pulse rate will be monitored at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline	90 days
Change in anthropometric measures compared to baseline	Body composition analyses ( Muscle-fat, obesity, segmental lean, ECW/TBW), height, hip circumference, waist circumference, weight and BMI will be monitored at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Number of participants with treatment-related changes in basic safety labs	Phlebotomy will be conducted at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Comprehensive Metabolic Panels and Complete Blood Counts will be assessed for treatment-related change from baseline	90 days
Change in urinalysis measures compared to baseline	Uninalysis will be conducted using Medline Urinalysis Reagent Strips at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Change in Hemoglobin A1c in percentage compared to baseline	Hemoglobin A1c in percentage will be measured at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Change in fasting Insulin compared to baseline	Fasting Insulin will be measured at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Change in Triglycerides compared to baseline	Triglycerides will be measured at individual visits ((visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Change in Total Cholesterol compared to baseline	Total Cholesterol will be measured at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Change in LDL-Cholesterol compared to baseline	LDL-Cholesterol will be measured at individual visits(visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline	90 days
Change in oxidized LDL-Cholesterol compared to baseline	Oxidized LDL-Cholesterol will be measured at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90). Collected data will be assessed for treatment-related change from baseline.	90 days
Changes in self-perceived health using a Health questionaire	The study staff will review the Health questionnaire at individual visits (visit 1- baseline, visit 2 - Day 30 and visit 3 - Day 90).	90 days

Collaborators and Investigators

• Sponsor: Nature's Sunshine Products, Inc.
• Investigators: Principal Investigator: Joseph Lamb, MD, Natures Sunshine

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NSP-CT-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No