90 Day

Daily Exogenous Ketones for Light to Moderate Depression

STUDY TITLE Daily Exogenous Ketones for Light to Moderate Depression
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

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

Author edit

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Informed consent

Review

Study author

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

In this protocol, participants with light to moderate depression will consume a daily ketone drink mix to induce a state of ketosis. The goal of this intervention is to assess the potential mood-enhancing effects of sustained ketosis on the alleviation of depressive symptoms.

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
Exogenous Ketones Drink Mix: $44
Outcome measures
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

Committment 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

The Intervention

Included Products & Services

Product Name: Exogenous Ketones Drink Mix

Quantity included: 2

Price: $44.00

Product Description: Support ketosis. Our most delicious tasting BHB exogenous ketone Base yet. Made to: Help reach ketosis, maintain energy levels, curb appetite, hydrate, and minimize keto flu symptoms. Sweetened with monk fruit for balanced sweetness. Added electrolytes for optimal hydration. Completely clean -- no artificial sweeteners or junk

Product Image:

Ingredients: Ingredients
Sodium Beta-Hydroxybutyrate
Calcium Beta-Hydroxybutyrate
Magnesium Beta-Hydroxybutyrate
Natural Flavor
Citric Acid
Malic Acid
Stevia Leaf Extract
The product also contains monk fruit as a sweetener.
Nutritional Information
Calories: 60
Sugar: 0g
Carbs: 0g
Dietary Fiber: 0g
Protein: 0g
Fat: 15g
Cholesterol: 0g
Additional Information
The product contains no artificial sweeteners.
It is gluten-free.
The drink mix contains electrolytes for hydration.
The BHB (beta-hydroxybutyrate) raw material is typically provided as:
690mg BHB sodium
620mg BHB calcium
380mg BHB magnesium

Product Safety: Risk Profile:
Electrolyte Imbalance:

High levels of exogenous ketones containing sodium, calcium, and magnesium can affect electrolyte balance, potentially leading to hypernatremia, hypercalcemia, or hypermagnesemia, especially in those with impaired renal function.
Gastrointestinal Distress:

Beta-hydroxybutyrate (BHB) salts may cause nausea, diarrhea, or stomach discomfort, especially in higher doses.
Dehydration:

Sodium content may increase water loss through the kidneys, raising the risk of dehydration.
Hypoglycemia:

Although not common, individuals with blood sugar regulation issues, such as those with diabetes, may experience hypoglycemia due to the metabolic shift induced by exogenous ketones.
Contraindications:
Renal Impairment:

Patients with chronic kidney disease or impaired renal function may be unable to properly excrete the excess electrolytes (sodium, calcium, magnesium) present in this formulation, increasing the risk of hyperkalemia and other complications.
Cardiovascular Conditions:

Individuals with hypertension or a history of cardiovascular disease should be cautious due to the sodium content, which may exacerbate high blood pressure.
Pregnancy and Lactation:

Not recommended for use during pregnancy or lactation due to limited safety data on exogenous ketone use in these populations.
Diabetes:

Individuals on insulin or glucose-lowering medications should use caution due to the potential for inducing hypoglycemia.
Safety Considerations:
Dosing:

Adherence to recommended dosage is critical to avoid excessive intake of electrolytes, particularly sodium and calcium.
Hydration:

Users should maintain adequate hydration to prevent dehydration, especially in conjunction with the sodium content.
Gradual Introduction:

To minimize gastrointestinal distress, the product should be introduced gradually, especially for individuals new to exogenous ketones.
Monitoring:

Individuals with existing health conditions should consult healthcare professionals before starting, and regular monitoring of electrolytes is advisable for those at risk of imbalances.
Adverse Events:
Common:

Gastrointestinal issues (nausea, diarrhea, abdominal discomfort)
Mild headache due to dehydration or electrolyte shifts
Fatigue during initial use, as the body adjusts to ketosis
Rare:

Hypernatremia, hypercalcemia, or hypermagnesemia in individuals with pre-existing electrolyte disorders or kidney impairment
Hypoglycemia in individuals with diabetes or blood sugar sensitivity
Allergic Reactions:

Rare allergic responses to natural flavorings or Stevia Leaf Extract may occur, though the risk is considered low.

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

Logging

Logging

Date Event Message Name