Metabolic Health 1: Power Line Evaluation; Effect Size Determination

NCT06486077 | Completed

• 1 other identifier: NSP-CT-021
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of participants with treatment-related changes in vital signs

  90 days

• Change in anthropometric measures compared to baseline

  90 days

• Number of participants with treatment-related changes in basic safety labs

  90 days

• Change in urinalysis measures compared to baseline

  90 days

• Change in Hemoglobin A1c in percentage compared to baseline

  90 days

Study Arms (1)

Power Line Program

EXPERIMENTAL

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

Interventions

Power Line Program DIETARY_SUPPLEMENT

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

Power Line Program

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nature's Sunshine Products, Inc.: lead

Study Sites (1)

The Hughes Center for Research and Innovation

Lehi, Utah, 84043, United States

Location

Study Officials

• Joseph Lamb, MD

  Natures Sunshine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label, Single Arm Study

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 3, 2024
• Study Start: May 20, 2025
• Primary Completion: August 26, 2025
• Study Completion: November 28, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)