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30 Day Insulin Balance Metabolic Health Optimization Protocol

E

Efforia, Inc

Status

Enrolling

Conditions

Insulin

Treatments

Dietary Supplement: Insulin Balance Formula - Hormetics Weight Optimization System

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Single Arm longitudinal where participants act as their own control
Experimental group
Description:
Single Arm longitudinal where participants act as their own control
Treatment:
Dietary Supplement: Insulin Balance Formula - Hormetics Weight Optimization System

Trial contacts and locations

1

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Central trial contact

Matthew Amsden

Data sourced from clinicaltrials.gov

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