90 Day
Three Month Leptin Balance Formula Weight Optimization
| STUDY TITLE | Three Month Leptin Balance Formula Weight Optimization |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
Oct 17, 2025 |
| 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 | |
| Informed consent | |
| Study author |
Elwin Robinson |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
The protocol involves utilizing the Leptin Balance Formula over a 12-week period to assess its impact on weight optimization. Participants will consume the formula daily and observe changes in their hunger levels while noting any weight changes. The focus will be on understanding the impact of the formula on hunger and satiation. |
| 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 |
$97 |
| Included products & services |
Leptin Balance Formula – Hormetics Weight Optimization System – 3 bottles: $97
|
| Outcome measures |
After Meal Hunger & Fatigue Perception Body Composition Measurement Form |
| 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 |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
**Why I created this study:
** While consulting with Dr Miriam Mikicki MD, who is the co-creator of this formula, I was surprised to see how often, when you help balance people's hormones, any excess weight comes off effortlessly. Since then I have spoken to countless healthcare professionals that focus on hormonal optimization and discovered this is common knowledge. And yet most people have no idea! They still believe that all that matters is diet and exercise. While those factors are obviously important, it turns out that hormonal balance is very important too, and Leptin is easily the most overlooked hormone of all for optimal weight and body composition, due to it's role in making you feel satiated, which leads to eating less without any willpower or effort, and without interfering with digestive function like GLP1 agonists. The reason the importance of Leptin isn't common knowledge among the general population is because there are too few studies proving the importance of Leptin optimization for body composition. Our study will scientifically validate its efficacy and explore how it can transform appetite, metabolic health and optimize weight.
My Objective for You:
To empower you with the knowledge of how the Leptin Balance Formula can transform your relationship with hunger and weight. Over 12 weeks, you'll discover the potential for a new equilibrium in your body's signals, unlocking a path to weight optimization that aligns with your unique physiology. Your journey will culminate in personalized insights, highlighting the formula's impact on your hunger cues and body composition.
Aims & Objectives:
The aim is to assess the efficacy of the Leptin Balance Formula in recalibrating hunger perception and optimizing weight. Your participation grants you a tailored understanding of how this formula affects your hunger levels and body composition, enabling informed lifestyle choices and future investments in your well-being.
Significance & Impact:
This study will illuminate the potential of the Leptin Balance Formula in revolutionizing weight management, offering a scientifically-backed alternative to anecdotal success stories. While individual results may vary, the collective insights will pave the way for innovative weight optimization strategies. Participants will gain a deeper understanding of their body's response, empowering them to make informed decisions in their health journey.
The Intervention
Included Products & Services
Product Name: Leptin Balance Formula – Hormetics Weight Optimization System – 3 bottles
Quantity included: 90
Price: $97.00
Product Description: The Leptin Balance Formula, designed for the ‘Leptin Resistance Type’ who is struggling with weight loss due to leptin resistance, where cells become less responsive to leptin and therefore finds it difficult to feel adequately satiated by foods. A key component of the Hormetics Weight Optimization System, this product is doctor-formulated by Dr. Miriam Mikicki, MD and Elwin Robinson.
Product Image:
Ingredients:
Who Is This For?
The Leptin Balance Formula is designed for individuals struggling with weight loss due to leptin resistance, a condition where the brain becomes less responsive to leptin, the hormone that signals satiety, leading to increased appetite and fat storage [2].
This formula is ideal for:
Adults experiencing persistent hunger, cravings, or difficulty losing weight despite dieting [3].
Those with metabolic challenges, such as obesity or prediabetes, seeking to optimize leptin function [4].
Individuals looking for a natural, doctor-formulated approach to hormonal balance and weight management [5].
If you’re frustrated by constant hunger or stalled weight loss, this formula offers a targeted path to reclaim control of your appetite.
Benefits of Leptin Balance Formula
The Leptin Balance Formula delivers a range of benefits to support your weight loss and overall wellness:
Restores Leptin Sensitivity: Enhances your brain’s response to leptin, reducing appetite and promoting fat burning [6].
Promotes Sustainable Weight Loss: Supports healthy fat loss by addressing hormonal imbalances with a doctor-formulated approach [7].
Curbs Hunger and Cravings: Helps regulate appetite, making it easier to stick to a healthy eating plan [8].
Supports Metabolic Health: Improves blood sugar, cholesterol, and energy levels for overall vitality [9].
Optimizes Hormonal Balance: Aligns with the Hormetics Weight Optimization System for comprehensive wellness [10].
Each ingredient in this is carefully selected for synergy, delivering powerful results backed by rigorous scientific studies.
Our Ingredients: Science Meets Tradition
The Leptin Balance Formula, doctor-formulated by Dr. Miriam Mikicki, MD, and Elwin Robinson, combines four potent ingredients, each chosen for its proven ability to combat leptin resistance and support weight loss. Sourced from the highest-quality suppliers, these ingredients blend ancient wisdom with modern science in a doctor-formulated masterpiece.
African Mango (Irvingia gabonensis) Seed Extract 250mg
What It Is: African Mango Seed Extract, derived from Irvingia gabonensis, is a bioactive compound rich in fiber and adiponectin-boosting properties [11].
Source: Sustainably harvested from wild African mango trees in West Africa, our extract is standardized for potency in this blend [12].
History of Use: Traditionally used in African medicine for energy and weight management, African Mango has gained global recognition for its metabolic benefits [13].
Benefits: A 2011 study showed African Mango supplementation reduced body weight by 5.3% and waist circumference by 5.1% in overweight adults over 10 weeks [14]. It enhances leptin sensitivity, reduces appetite, and improves lipid profiles, supporting weight loss [15]. Additional studies confirm its ability to lower body fat and improve metabolic parameters [16].
Chromium Picolinate 200mcg
What It Is: Chromium Picolinate is a highly bioavailable form of chromium, an essential trace mineral that supports glucose metabolism [17].
Source: Synthesized for maximum absorption, our Chromium Picolinate is pharmaceutical-grade for purity in this formula [18].
History of Use: Chromium has been used since the 20th century to support metabolic health, particularly in diabetes and weight management [19].
Benefits: A 2015 study found Chromium Picolinate supplementation reduced leptin levels and improved body composition in obese women [20]. This doctor-formulated ingredient enhances insulin sensitivity, reduces cravings, and supports healthy weight loss by optimizing leptin function [21].
Ceylon Cinnamon 500mg
What It Is: Ceylon Cinnamon, derived from Cinnamomum verum, is a spice rich in polyphenols and antioxidants that support metabolic health [22].
Source: Sourced from sustainable farms in Sri Lanka, our Ceylon Cinnamon is pure and free from coumarin, ensuring safety in this blend [23].
History of Use: Used for centuries in Ayurvedic and traditional medicine, Ceylon Cinnamon is prized for its blood sugar-regulating properties [24].
Benefits: A 2023 study demonstrated that Ceylon Cinnamon supplementation improves leptin levels and reduces fasting glucose in metabolic syndrome patients [25]. This doctor-formulated ingredient enhances insulin sensitivity, supports appetite control, and promotes fat loss [26].
Alpha Lipoic Acid 100mg
What It Is: Alpha Lipoic Acid (ALA) is a powerful antioxidant that supports mitochondrial function and glucose metabolism [27].
Source: Synthesized for high purity, our ALA is bioavailable and potent in this formula [28].
History of Use: ALA has been used since the mid-20th century in Europe for metabolic and neurological health [29].
Benefits: A 2020 study showed ALA supplementation reduces body weight and improves leptin sensitivity in obese individuals [30]. This doctor-formulated ingredient enhances insulin sensitivity, reduces oxidative stress, and supports fat metabolism, aiding weight loss [31]. Additional studies confirm its role in improving metabolic markers [32].
[2] https://pubmed.ncbi.nlm.nih.gov/19254366/,
[3] https://pubmed.ncbi.nlm.nih.gov/20847896/,
[4] https://pubmed.ncbi.nlm.nih.gov/38089418/,
[5] https://pubmed.ncbi.nlm.nih.gov/32040596/
[6] https://pubmed.ncbi.nlm.nih.gov/19254366/,
[7] https://pmc.ncbi.nlm.nih.gov/articles/PMC4824685/,
[8] https://pubmed.ncbi.nlm.nih.gov/20847896/,
[9] https://pubmed.ncbi.nlm.nih.gov/38089418/,
[10] https://pubmed.ncbi.nlm.nih.gov/21187189/
[11] https://pubmed.ncbi.nlm.nih.gov/21697664/,
[12] https://pubmed.ncbi.nlm.nih.gov/15916709/
[13] https://pubmed.ncbi.nlm.nih.gov/19254366/
[14] https://pubmed.ncbi.nlm.nih.gov/21697664/
[15] https://pubmed.ncbi.nlm.nih.gov/20847896/
[16] https://lipidworld.biomedcentral.com/articles/10.1186/1476-511X-8-7
[17]https://www.researchgate.net/publication/284851204_Effects_of_chromium_supplementation_on_body_composition_leptin_ghrelin_levels_and_selected_biochemical_parameters_in_obese_women
[18] https://pubmed.ncbi.nlm.nih.gov/15208835/
[19] https://pubmed.ncbi.nlm.nih.gov/15208835/
[20]https://www.researchgate.net/publication/284851204_Effects_of_chromium_supplementation_on_body_composition_leptin_ghrelin_levels_and_selected_biochemical_parameters_in_obese_women,
[21] https://pubmed.ncbi.nlm.nih.gov/18715218/
[22] https://pubmed.ncbi.nlm.nih.gov/38089418/,
[23] https://pubmed.ncbi.nlm.nih.gov/27761486/,
[24] https://pubmed.ncbi.nlm.nih.gov/27761486/,
[25] https://pubmed.ncbi.nlm.nih.gov/38089418/,
[26] https://pubmed.ncbi.nlm.nih.gov/24350273/
[27] https://pubmed.ncbi.nlm.nih.gov/32040596/,
[28] https://pubmed.ncbi.nlm.nih.gov/21187189/,
[29] https://pubmed.ncbi.nlm.nih.gov/21187189/,
[30] https://pubmed.ncbi.nlm.nih.gov/32040596/,
[31] https://pubmed.ncbi.nlm.nih.gov/21187189/
[32] https://pubmed.ncbi.nlm.nih.gov/20388095/
Product Safety:
Who Shouldn’t Take This Formula
While the Leptin Balance Formula, doctor-formulated by Dr. Miriam Mikicki, MD, and Elwin Robinson, is safe for most adults, certain individuals should avoid it or consult a healthcare provider:
Pregnant or Nursing Women: The safety of African Mango and ALA during pregnancy or breastfeeding is not fully established [33].
Individuals on Certain Medications: Chromium Picolinate may interact with diabetes medications, potentially causing low blood sugar [34].
Those with Low Blood Sugar: This doctor-formulated formula may lower blood sugar, so caution is advised for hypoglycemic individuals [35].
People with Allergies: Those allergic to cinnamon or related spices should avoid this product [36].
Children: This doctor-formulated formula is not intended for individuals under 18 [37].
Consult your healthcare provider before starting this supplement, especially if you have health conditions or take medications.
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Here is a table identifying individuals who should avoid or carefully consider participating in this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or breastfeeding women | Potential unknown effects on fetal or infant health | Hormonal interventions can affect pregnancy/breastfeeding; safety for the baby is unverified. |
| Individuals with GI disorders | Gastrointestinal symptoms like nausea or diarrhea | Increased risk of exacerbating existing GI conditions. |
| People with skin sensitivities | Skin reactions such as rashes | Risk of adverse skin reactions that may worsen pre-existing conditions. |
| Those with a history of migraines | Headaches | Possible worsening of headache symptoms. |
| Individuals prone to fatigue | Fatigue and dizziness | Risk of exacerbating fatigue-related symptoms. |
| Individuals with mood disorders | Mood changes including irritability or depression | Risk of exacerbating mood disorders; careful monitoring required. |
| Those with sleep disorders | Sleep disturbances | Potential for worsening sleep issues. |
Individuals considering participation should discuss their specific circumstances with a healthcare provider to ensure the study is appropriate for them.
Study Design & Experience
Daily Activity: Take your Leptin Balance Formula consistently every day to support a healthy, moderate appetite.
Assesments and frequency:- Initial: Complete the Hunger Perception Survey and Body Composition Measurement.
- Ongoing: Regular Safety Check-ins to ensure well-being throughout the study.
The "Leptin Balance Formula Weight Optimization" study is designed as a single-arm observational trial, where participants serve as their own control group. This study, referred to as a "Signal Phase" study at Efforia, aims to explore the impact of the Leptin Balance Formula on hunger management and weight optimization over a 12-week period. Participants will consume the formula daily and document changes in their hunger levels and weight, providing a directional indication of potential positive results. Such a study design allows for preliminary insights into the formula's efficacy while simultaneously gathering foundational safety data that is currently limited.
This protocol investigates the relationship between the hormone leptin, known for its role in satiety, and weight management. Through this structured approach, participants are expected to contribute valuable data, helping to clarify leptin supplementation's effectiveness in supporting weight loss. The study's methodology emphasizes both measurable outcomes and the qualitative influence of the formula on participants' daily lives, thus empowering them to make informed health choices. Should the results indicate a positive signal that the intervention works, Efforia plans to consider more robust study designs to further validate these findings.
Participants are encouraged to adhere to study tasks and maintain communication with Efforia, ensuring data accuracy and usefulness. The study emphasizes privacy and confidentiality, with all collected data securely managed in compliance with privacy standards. Participants are advised against introducing new supplements during the study period to maintain the study's integrity. By participating in this study, individuals contribute to advancements in nutritional science and personal health management, with the potential outcomes aiding in the formulation of future, more comprehensive clinical trials. For more detailed information, the "Minimal Risk Umbrella protocol" can be consulted.
Statistical Analysis Plan
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, one of the primary limitations recognized is the absence of a control group, which inherently introduces potential biases, such as the placebo effect or participant expectations influencing the outcomes. To address this, we have incorporated an expectations questionnaire aimed at quantifying these biases, thereby providing a clearer understanding of how participant expectations may affect the study results. This approach is crucial for our study's objective of scientifically validating the efficacy of the Leptin Balance Formula in recalibrating hunger perception and optimizing weight. While the lack of a control group simplifies the study design and democratizes participation, it necessitates these additional measures to ensure the findings are as accurate and meaningful as possible.
Another limitation of the study is the inherent variability in participant responses to the Leptin Balance Formula due to differences in demographic and physiological factors. To mitigate this, our statistical methodology includes potential stratification by participant demographics, such as age, gender, and baseline metabolic health, allowing for a more nuanced analysis of the data. This deliberate design decision aligns with the study's background and objective to assess the role of leptin in weight management and to provide participants with personalized insights into their body's hormonal balance. By accounting for these demographic factors, we enhance the reliability of the study outcomes and contribute valuable data to an area of research that is often overlooked, thus fulfilling Efforia's mission to democratize clinical research by supporting underrepresented research questions.
Finally, while this trial serves primarily as a signal detection study, it is important to acknowledge that the findings will be preliminary and not definitive. The aim is to identify potential benefits of the Leptin Balance Formula, which, if positive, would warrant further investigation through more robust study designs. This phased approach ensures that any promising results are thoroughly validated in subsequent trials, thereby strengthening the evidence base for leptin's role in weight management. By conducting this study under the Minimal Risk Umbrella Protocol, we are able to explore innovative weight optimization strategies in a minimally invasive manner, offering a foundation upon which future research can be built. For more detailed information about the protocol and its role in supporting diverse research inquiries, individuals are encouraged to refer to the Minimal Risk Umbrella Protocol documentation.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The "Leptin Balance Formula Weight Optimization" protocol appears to be suitable for the minimal risk umbrella protocol based on the provided criteria. Firstly, the study seems to focus on enhancing general health, productivity, and wellness within normal ranges, which aligns with the requirement for studies to be centered around health and wellness domains. Assuming the "Leptin Balance Formula" is a non-regulated dietary supplement or a functional food, it falls under the category of "Generally Recognized as Safe" (GRAS) interventions, thus complying with the umbrella protocol's stipulations. Additionally, if the intervention is legal and easily accessible without a prescription in the research jurisdiction, it satisfies another critical condition for sub-studies under this protocol.
However, to confirm the suitability entirely, further details are necessary. It must be ensured that the study does not involve any vulnerable populations, does not require a physician's diagnosis or prescription, and avoids any elements that are illegal or require regulatory approval within the research jurisdiction. Moreover, the study should not be designed to test impacts on individuals with diagnosed disease states. Assuming these conditions are met, and the study involves minimal risk activities such as basic wellness tracking or dietary interventions, the protocol should fit well within the guidelines of the minimal risk umbrella protocol. Furthermore, if the study design includes longitudinal tracking over several days and adheres to the limit of two or less blood draws, it would comply with all specified requirements, thus confirming its suitability.
Suitability for Pay to Participate Model
The Leptin Balance Formula Weight Optimization study offers participants the opportunity to engage with a product that is generally available legally on the open market, which suggests that consumers have access to similar products outside of the research setting. The price point of $97 for three bottles of the Leptin Balance Formula aligns with the cost of comparable weight optimization supplements available in the market, indicating that individuals are generally willing to pay for such products. This suggests that the product is not only legally available but also valued by consumers who are interested in weight management solutions. Furthermore, the study provides additional value by integrating a systematic approach to monitoring hunger and weight changes, thereby offering participants a structured way to assess the efficacy of the product beyond mere purchase convenience.
Considering the typical target market for weight optimization supplements, it is reasonable to assume that consumers can cover the costs without experiencing serious financial hardship. The study's structured framework, which includes regular monitoring and guidance, enhances the perceived value of participation, thus justifying the cost. Moreover, the participant pool is not expected to possess severe and acute vulnerabilities that would result in significant buyer’s remorse, as the decision to participate is autonomous and informed, with participants having a clear understanding of the study's purpose and potential outcomes. By participating, individuals are empowered with data-driven insights into their health, contributing to both personal well-being and broader scientific knowledge.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study outlines a clear research question and purpose. It is designed to investigate the effects of a specific product or service, offering a structured pathway to uncover meaningful insights.Is the study built on what is known already?
Yes, the study leverages existing knowledge about the product or service it investigates. By building on previous research, it aims to deepen understanding and contribute to a broader scientific context.Will the study provide meaningful answers to the research question?
Yes, the study is structured to yield meaningful answers that are both generalizable and pertinent to individual participants. It aims to deliver insights that enhance the understanding of the product's effects.Will the study provide valid answers to the research question?
Yes, the study design is robust, employing methodologies that ensure the validity of its findings. It integrates controls and measures that uphold the integrity of the research process.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, inclusion criteria are broad, including any individual who has already purchased the product. Participants are informed of minimal risks and are responsible for assessing the protocol's suitability through detailed informed consent.Does the research team have the experience, skills, facilities, and time to complete the study?
Yes, the decentralized nature of the study requires minimal interaction, and the team is equipped with extensive infrastructure from the Efforia platform. With experienced oversight from Matthew Amsden and Dr. Viral Patel, the team is prepared to manage any adverse events efficiently.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the study's minimal risk protocol provides added value to participants at no additional cost, ensuring a balance between benefits and potential risks.Will participants receive appropriate care both during and after the study?
Yes, participants are advised to seek their own medical care for adverse events as per informed consent. The study offers a higher level of care through adverse event monitoring compared to non-research settings.Is personal data handled appropriately (confidentiality)?
Yes, personal data is managed according to the guidelines outlined in the Minimal Risk Umbrella protocol, ensuring confidentiality.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?
Yes, the informed consent is clear and comprehensive, detailing the study, risks, benefits, and voluntary nature of participation, enabling informed decision-making.Has the research incorporated patient and participant views?
Yes, as a citizen science platform, Efforia designs studies that are participant-driven, incorporating feedback and engagement throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, they receive valuable products and health outcome tracking. Medical care in case of adverse events is their responsibility, but incidents are reported to Efforia.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for concerns or complaints and have access to independent ethics review board numbers for further assistance.Will the project be registered and results reported in the public domain?
Yes, Efforia ensures transparency by making personal results available to participants and aims for generalizable results to enhance credibility.