90 Day

Hormonal Balance and Body Composition Protocol

STUDY TITLE Hormonal Balance and Body Composition Protocol
Submitted under umbrella

Umbrella Protocol for Efforia Personalized Agentic Hypothesis Discovery & Experiential Proof Trials

Date submitted

—

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

—

Recruitment page preview

Preview

Informed consent

Review

Study author

Elwin Robinson

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol involves taking the Estrogen Balance Formula from the Hormetics Weight Optimization System to support hormonal balance and optimize body composition. Participants will take the formula daily. The study will focus solely on the formula without additional instructions on diet or exercise to ensure outcomes can be effectively isolated.

Participant engagement length

90 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$0

Included products & services
Estrogen Balance Formula – Hormetics Weight Optimization System – 3 bottles: $117
Outcome measures

Depression, Anxiety and Stress Scales (DASS-21) Survey

NIH Toolbox® Item Bank v3.0 – General Life Satisfaction (Ages 18+)

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

ClinicalTrials.gov

Yes

Commitment to list findings on ClinicalTrials.gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

Why I created this study:

Hormonal balance is a cornerstone of overall health, impacting everything from mood to metabolism. Recent studies suggest that optimized estrogen levels can significantly improve body composition and emotional well-being. While chatter on social media and popular press often touts the benefits of hormonal supplements, scientific validation remains limited. This study aims to bridge the gap between anecdotal claims and scientific evidence, providing credible insights into how the Estrogen Balance Formula affects body composition and mood.

My Objective for You:

My goal is to empower you with personalized insights into how the Estrogen Balance Formula can optimize your hormonal health and body composition. By participating, you'll gain a clearer understanding of how this product impacts your mood, overall satisfaction, and physical well-being. Ultimately, you'll be equipped to make informed decisions regarding your proactive health management, tailored to your unique physiological needs.

Aims & Objectives:

This study aims to evaluate the effects of the Estrogen Balance Formula on hormonal balance and body composition in healthy adults. Participants will receive personalized results, enabling them to see firsthand how the product impacts their hormones, mood, and overall satisfaction, helping them to make more informed choices about their health and lifestyle investments.

Significance & Impact:

The significance of this study lies in its potential to validate the benefits of the Estrogen Balance Formula and its impact on hormonal balance and body composition. Expected outcomes include improvements in mood, life satisfaction, and physical metrics. However, limitations such as individual variability and lifestyle factors must be considered. The findings will provide valuable insights for participants and the broader community interested in evidence-based approaches to hormonal health optimization.

The Intervention

Included Products & Services

Product Name: Estrogen Balance Formula – Hormetics Weight Optimization System – 3 bottles

Quantity included: 1

Price: $117.00

Product Description: The protocol involves utilizing the Estrogen Balance Formula over a 3 month period to assess its impact on weight optimization. Participants will consume the formula daily and observe changes in body composition and estrogen levels tested with a blood test. The focus will be on understanding the impact of the formula on healthy estrogen detoxification and targeted fat loss, particularly around the lower body.

Product Image: Estrogen Balance Formula – Hormetics Weight Optimization System – 3 bottles

Ingredients: The Estrogen Balance Formula combines nine potent ingredients, each chosen for its proven ability to address estrogen dominance and support weight loss. Sourced from premium suppliers, these ingredients blend cutting-edge science with time-honored remedies.

Calcium D-Glucarate 500mg
What It Is: Calcium D-Glucarate is a compound that supports detoxification by inhibiting beta-glucuronidase, an enzyme that can increase estrogen recirculation.
Source: Derived from natural glucaric acid found in fruits and vegetables, highly bioavailable.

TUDCA (Tauroursodeoxycholic Acid) 250mg
What It Is: TUDCA is a bile acid derivative that supports liver function and cellular health.
Source: Synthesized for high purity, pharmaceutical-grade for efficacy.

Taurine 250mg
What It Is: Taurine is an amino acid that supports liver function, bile production, and cellular health.
Source: Synthesized for purity, bioavailable and effective.

Chrysin 250mg
What It Is: Chrysin is a flavonoid found in passionflower and honey, known for its aromatase-inhibiting properties.
Source: Extracted from natural botanical sources, standardized for potency.


DIM (Diindolylmethane) 100mg
What It Is: DIM is a compound derived from cruciferous vegetables like broccoli, promoting healthy estrogen metabolism.
Source: Sourced from high-quality vegetable extracts, standardized for consistency.

Vitex (Chasteberry) 20mg
What It Is: Vitex, derived from Vitex agnus-castus, is an herbal extract that supports hormonal balance.
Source: Harvested from organic chasteberry plants, standardized for potency.

Zinc 15mg
What It Is: Zinc is an essential mineral that supports hormonal regulation and immune function.
Source: Sourced from natural mineral deposits, chelated for optimal absorption.

Vitamin B6 10mg
What It Is: Vitamin B6 (pyridoxine) is a B-vitamin crucial for neurotransmitter and hormone synthesis.
Source: Synthesized for high bioavailability, pure and effective.

Vitamin D3 1000 IU
What It Is: Vitamin D3 (cholecalciferol) is a fat-soluble vitamin that supports hormonal and metabolic health.
Source: Derived from natural lanolin, highly bioavailable.

Product Safety: **Product Title:** Estrogen Balance Formula – Hormetics Weight Optimization System – 3 Bottles

**Product Description:**
Introducing the Estrogen Balance Formula from Hormetics, designed to optimize weight management through hormonal balance. This three-bottle pack provides a comprehensive three-month protocol to help users effectively manage and influence their estrogen levels for improved health outcomes.

**Key Benefits:**
- **Hormonal Harmony:** Designed to support the balance of estrogen levels, our formula aids in maintaining hormonal equilibrium essential for optimal health.
- **Weight Management:** This protocol is tailored to assist in targeting and reducing fat, particularly in the lower body, by supporting healthy estrogen metabolism.
- **Enhanced Body Composition:** Regular consumption as per the recommended protocol can lead to noticeable improvements in body composition, making it a vital component of your health regimen.
- **Evidence-Based Approach:** Participants are encouraged to monitor changes through monthly blood tests, allowing for the assessment of the formula’s effectiveness on estrogen levels and body fat distribution.

**Usage Instructions:**
- **Duration:** Each bottle is intended for one month's use, completing a full course over three months.
- **Daily Intake:** Consume daily as per the instructions on the bottle or as advised by your healthcare provider.
- **Monitoring Progress:** It is recommended to undergo periodic blood tests to evaluate estrogen levels and body composition changes over the course of the treatment.

**Ideal for:**
Individuals looking to optimize their weight through a scientifically formulated approach to estrogen balance. Particularly beneficial for those experiencing stubborn fat accumulation in estrogen-sensitive areas.

**Note:** Always consult with a healthcare professional before starting any new dietary supplement, especially if you are pregnant, nursing, have existing health conditions, or are taking other medications.

Embark on your journey to a more balanced and optimized body with Hormetics’ Estrogen Balance Formula. Enjoy the transformative effects of targeted fat loss and hormonal balance, backed by a scientifically driven protocol.

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire