30 Day Insulin Balance Metabolic Health Optimization Protocol
ConditionInsulin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEfforia, Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults 18+ who are generally healthy
Ability to read and comprehend English
Ability to willfully consent and follow study procedures and tasks
Disqualifiers
Individuals with Known Allergies
Pregnant or Nursing Individuals
Individuals with Insulin Disorders
Individuals with GI Disorders
Trial design
Design model
Single group
Treatments tested in this trial
Insulin Balance Formula - Hormetics Weight Optimization System
Dietary supplementThe 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single Arm longitudinal where participants act as their own controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)2
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.
Time frame
Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)3
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.
Time frame
Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)4
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov