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NCT Number: NCT07478497

30 Day Insulin Balance Metabolic Health Optimization Protocol

Explore how a dietary supplement can help support healthy insulin levels and its impact on weight, fatigue, and sugar cravings. The Insulin Balance Formula and Hormetics Weight Optimization System is designed for people who are generally healthy and want to support and maintain healthy insulin levels to reach general health goals.

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Key information

Conditions

Insulin Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Treatment activities:

Daily Activity: Take 3 capsules of the Insulin Balance Supplement daily, ideally 1 capsule before each meal or all at once for convenience. Begin with 1 capsule to assess tolerance and increase to the recommended dose. Take on an empty stomach or with a meal if needed.

Assessments and frequency:

Body Composition Measurement: Complete the assessment as required. PROMIS Sleep Disturbance Scale: Complete the assessment as required. Carbohydrate Craving Questionnaire: Complete the assessment as required. After Meal Hunger & Fatigue Perception: Complete the assessment as required.

Methodology:

The "Insulin Balance Metabolic Health and Weight Optimization Protocol" is an observational study designed to investigate the effects of a dietary supplement on insulin levels and its subsequent impact on weight management, fatigue, and sugar cravings. In this study, participants serve as their own controls in a single-arm design, a scientific approach known as the "Signal Phase" at Efforia. This trial aims to detect initial positive outcomes that suggest the supplement's effectiveness in promoting metabolic health. During this phase, not only will potential benefits be identified, but it will also gather critical safety data that is currently limited, thereby paving the way for more comprehensive studies in the future.

Participants will partake in a 30-day structured protocol, during which they will incorporate the Insulin Balance Formula into their daily routines alongside a balanced diet. The study is crucial because it addresses the challenges many face in maintaining stable insulin and blood sugar levels, which are essential for metabolic health. By closely monitoring their response to the supplement, participants will provide valuable insights into how this nutritional strategy may enhance energy levels, improve mood consistency, and support healthy weight maintenance. Their role is pivotal in assessing the formula's impact under real-world conditions, generating meaningful data that can inform future interventions.

Throughout the study, participants are encouraged to actively engage and provide honest feedback, ensuring accurate, personalized results. The study emphasizes the importance of privacy and data confidentiality, assuring participants that their information will only be used within the research context. Participants are also advised against introducing new supplements or health interventions during the trial to avoid confounding results. Should any health concerns arise, they are instructed to seek medical attention immediately. The insights gained from this study could significantly advance understanding of nutritional support for managing blood sugar levels, potentially leading to more robust research designs if positive signals are detected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18+ who are generally healthy
  • Ability to read and comprehend English
  • Ability to willfully consent and follow study procedures and tasks

Exclusion criteria

  • Individuals with Known Allergies
  • Pregnant or Nursing Individuals
  • Individuals with Insulin Disorders
  • Individuals with GI Disorders
  • Individuals with Mental Health Conditions
  • Individuals with Sleep Disorders
  • Individuals on Medication
  • Athletes under Specific Regulations
  • Individuals Sensitive to Fatigue

Treatment and study plan

Insulin Balance Formula - Hormetics Weight Optimization System

Dietary Supplement

The Insulin Balance Formula, doctor-formulated by Dr. Miriam Mikicki, MD, and Elwin Robinson, combines five potent ingredients, each chosen for its proven ability to combat insulin resistance and support weight loss. Sourced from premium suppliers, these ingredients blend ancient wisdom with modern science:

Berberine 500mg Beta Alanine 500 mg Zinc Citrate 15 mg Folate 200 mcg Fenugreek Extract 500 mg

Primary outcomes

  1. Waist Circumference Measured by Flexible Tape Measure

    Time frame: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)

    Waist circumference will be measured in centimeters (cm) using a non-elastic, flexible anthropometric tape measure. Measurements will be taken at the midpoint between the lowest rib and the iliac crest with the participant standing, at the end of a normal exhalation. Two measurements will be obtained, and the average value will be recorded.

  2. PROMIS Sleep Disturbance Scale

    Time frame: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)

    Measurement Scale:

    The PROMIS Sleep Disturbance Scale is a standardized, participant-reported questionnaire consisting of multiple items rated on a 5-point Likert scale (typically ranging from 1 = "Not at all" to 5 = "Very much"). Item responses are summed and converted to a T-score standardized to the general population (mean = 50, standard deviation = 10).

    Score Interpretation:

    Higher scores indicate greater sleep disturbance (worse sleep quality), while lower scores indicate better sleep quality.

  3. Carbohydrate Craving Questionnaire

    Time frame: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)

    Measurement Scale:

    The Carbohydrate Craving Questionnaire (CCQ) is a validated, participant-reported questionnaire designed to assess the frequency and intensity of carbohydrate-related cravings. Items are rated on a Likert-type scale (typically ranging from 1 = "Strongly disagree" to 6 or 7 = "Strongly agree," depending on the CCQ version). Item responses are summed to generate a total score.

    Score Interpretation:

    Higher total scores indicate greater carbohydrate craving severity, while lower scores indicate lower levels of carbohydrate craving.

  4. After Meal Hunger & Fatigue Perception

    Time frame: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30), along with random repetitions 6 times per 2 weeks throughout study.

    This survey aims to understand how individuals perceive different stages of hunger and fatigue after their most recent meal. The respondents are required to select the option that best describes their current state of hunger or fullness, based on a scale of 1 through 10, with 10 being the most favorable. In addition, this survey measures current state of hunger-associated fatigue from "very drowsy" to "very alert" with "very alert" being the most favorable.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Amsden

CONTACT

[email protected]

(646) 679-2479

Sponsors and collaborators

Lead sponsor

Efforia, Inc

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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