Metabolic Health 1: Power Line Evaluation; Effect Size Determination
NCT Number: NCT06486077
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Health
Interventions: DIETARY_SUPPLEMENT: Power Line Program
Sponsor: Nature's Sunshine Products, Inc.
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2024-12
Locations: The Hughes Center for Research and Innovation, Lehi, Utah, 84043, United States

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.

Primary Outcome Measures: 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, visit 3 - Day 60 and visit 4 - 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: Number of participants with treatment-related changes in basic safety labs, Phlebotomy will be conducted at individual visits (visit 1- baseline, visit 3 - Day 60 and visit 4 - Day 90). Comprehensive Metabolic Panels and Complete Blood Counts 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, visit 3 - Day 60 and visit 4 - 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, visit 3 - Day 60 and visit 4 - Day 90). Collected data 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - 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 3 - Day 60 and visit 4 - Day 90). Collected data will be assessed for treatment-related change from baseline., 90 days|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|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, visit 3 - Day 60 and visit 4 - Day 90)., 90 days