Clinical trial NCT06486077: Metabolic Health 1: Power Line Evaluation; Effect Size Determination
Official title: Full Title: Metabolic Health 1: Power Line Evaluation; Effect Size Determination
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Health
Lead sponsor: Nature's Sunshine Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label, Single Arm Study
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
timeFrame: 90 days
Secondary outcomes:
measure: Number of participants with treatment-related changes in basic safety labs
timeFrame: 90 days
measure: Number of participants with treatment-related changes in vital signs
timeFrame: 90 days
measure: Change in anthropometric measures compared to baseline
timeFrame: 90 days
measure: Change in urinalysis measures compared to baseline
timeFrame: 90 days
measure: Change in Hemoglobin A1c in percentage compared to baseline
timeFrame: 90 days
measure: Change in fasting Insulin compared to baseline
timeFrame: 90 days
measure: Change in Triglycerides compared to baseline
timeFrame: 90 days
measure: Change in Total Cholesterol compared to baseline
timeFrame: 90 days
measure: Change in LDL-Cholesterol compared to baseline
timeFrame: 90 days
measure: Change in oxidized LDL-Cholesterol compared to baseline
timeFrame: 90 days
measure: Change in HDL-Cholesterol compared to baseline
timeFrame: 90 days
measure: Changes in self-perceived health using a Health questionaire
timeFrame: 90 days
Other outcomes:
Locations:
city: Lehi
country: United States
facility: The Hughes Center for Research and Innovation
state: Utah
Study officials:
affiliation: Natures Sunshine
name: Joseph Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: