30 Day Insulin Balance Metabolic Health Optimization Protocol

NCT07478497 | Recruiting

• 1 other identifier: 47576
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin

Outcome Measures

Primary Outcomes (4)

• Waist Circumference Measured by Flexible Tape Measure

  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.

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

• PROMIS Sleep Disturbance Scale

  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.

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

• Carbohydrate Craving Questionnaire

  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.

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

• After Meal Hunger & Fatigue Perception

  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.

  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.

Study Arms (1)

Single Arm longitudinal where participants act as their own control

EXPERIMENTAL

Single Arm longitudinal where participants act as their own control

Dietary Supplement: Insulin Balance Formula - Hormetics Weight Optimization System

Interventions

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

Single Arm longitudinal where participants act as their own control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matthew Amsden

CONTACT

(646) 679-2479; help@efforia.com

Study Design

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

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: March 17, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-12

Locations

US (1)