Metabolic HealthNCT06486077
Metabolic Health 1: Power Line Evaluation; Effect Size Determination
A study testing Power Line Program in people with Metabolic Health, run by Nature's Sunshine Products, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health
- What is being tested?
- Power Line Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hughes Center for Research and Innovation
Lehi, Utah, 84043
About this study
Official title: 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.
Read the 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
- Being tested
- Power Line Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Line ProgramDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Power Line Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (12)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start20 May 2025
- Primary completion26 Aug 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label, Single Arm Study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's Sunshine Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Lamb, MD, Principal investigator, Natures Sunshine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486077
- Sponsor's protocol ID
- NSP-CT-021
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Title: Metabolic Health 1: Power Line Evaluation; Effect Size Determination
- ClinicalTrials.gov ID
- NCT06486077
- Acronym / sponsor ID
- NSP-CT-021
- Conditions
- Metabolic Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nature's Sunshine Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label, Single Arm Study
| Arm | Type | Receives |
|---|---|---|
| Power Line Program | Experimental | Dietary Supplement: Power Line ProgramDaily 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Line ProgramPower 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 | Dietary supplement | Power Line Program |
Primary outcome
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Time frame: 90 days
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.
12 secondary outcomes
Number of participants with treatment-related changes in vital signs
Time frame: 90 days
Change in anthropometric measures compared to baseline
Time frame: 90 days
Number of participants with treatment-related changes in basic safety labs
Time frame: 90 days
Change in urinalysis measures compared to baseline
Time frame: 90 days
Change in Hemoglobin A1c in percentage compared to baseline
Time frame: 90 days
Change in fasting Insulin compared to baseline
Time frame: 90 days
Change in Triglycerides compared to baseline
Time frame: 90 days
Change in Total Cholesterol compared to baseline
Time frame: 90 days
Change in LDL-Cholesterol compared to baseline
Time frame: 90 days
Change in oxidized LDL-Cholesterol compared to baseline
Time frame: 90 days
Change in HDL-Cholesterol compared to baseline
Time frame: 90 days
Changes in self-perceived health using a Health questionaire
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Lamb, MD principal investigator
Natures Sunshine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Line Program in people with Metabolic Health, run by Nature's Sunshine Products, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0). (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.