NCT07478497

30 Day Insulin Balance Metabolic Health Optimization Protocol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Efforia, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Insulin

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Insulin Balance Formula - Hormetics Weight Optimization System	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

Timeline

• Start date: 2025-10-21
• Primary completion: 2026-10-21
• Completion: 2026-10-21
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States