60 Day
Ketosis Enhancement with Exogenous Ketones
| STUDY TITLE | Ketosis Enhancement with Exogenous Ketones |
|---|---|
| Submitted under umbrella | |
| 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 | |
| Author edit | |
| Informed consent | |
| Study author |
Akash Warkhade |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This protocol involves the combination of Exogenous Ketones supplementation and a low-carb, high-fat ketogenic diet to enhance ketosis and support weight loss. Participants will adhere to the ketogenic diet plan, which focuses on high-fat, moderate protein, and low carbohydrate intake. The synergistic effect of the diet and supplementation aims to improve metabolic health and promote effective weight management. |
| Participant engagement length |
60 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 |
Base Ketones – Exogenous Ketones Drink Mix – Unflavored Capsules 2-Pack: $42
|
| Outcome measures |
Fatigue Perception and Impact Survey Neuro-QOL Item Bank v1.0 –Fatigue – Short 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 |
| Committment 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:
In a world where waistlines are expanding and energy is dwindling, the ketogenic diet has been hailed as a miracle. From social media influencers to scholarly journals, the low-carb, high-fat diet has shown promise in revving up our metabolic engines. However, the chatter about exogenous ketones enhancing this metabolic state is growing louder. This study, combining the ketogenic diet with exogenous ketones, aims to scientifically explore their combined impact on weight management and metabolic health, ensuring we separate fad from fact.
My Objective for You:
My goal is to guide you on this transformative journey, optimizing your metabolic health and supporting your weight management efforts through the dual power of a ketogenic diet and exogenous ketones. You'll learn how this dynamic duo can energize your body and help combat fatigue, making each day brighter and more productive. Together, we'll unlock the potential of these interventions and provide you with insights that can shape your health decisions and lifestyle for years to come.
Aims & Objectives:
Our aim is to evaluate the effects of exogenous ketones combined with a ketogenic diet on metabolic health and weight management. By participating, you'll receive personalized insights into how these interventions affect your fatigue levels and overall well-being, empowering you to make informed choices about your health and lifestyle investments.
Significance & Impact:
This study is significant in its potential to redefine weight management strategies by scientifically validating the synergistic effects of exogenous ketones and a ketogenic diet. While some limitations exist, such as individual variability in adherence and response, the expected outcomes could revolutionize dietary interventions for metabolic health. By participating, you'll contribute to groundbreaking research while gaining personalized knowledge to fuel your future health decisions.
The Intervention
Included Products & Services
Product Name: Base Ketones – Exogenous Ketones Drink Mix – Unflavored Capsules 2-Pack
Quantity included: 30
Price: $42.00
Product Description: Support fasting and ketosis with our Base Ketones supplement powder. It’s formulated to provide the boost of ketones and electrolytes you need to feel full for longer and help you extend your fast. It also provides a caffeine free energy boost during exercise and supports mental clarity. Our Base Ketones supplement supports your body as it adapts to ketosis.
Product Image:
Ingredients:
Serving size two Base BHB Softgels (though users may take up to 6 per day):
64 mg of Calcium (as Calcium Beta-Hydroxybutyrate), or 5% of the Daily Value.
70 mg of Sodium (as Sodium Beta-Hydroxybutyrate), or 3% of the Daily Value.
400 mg of Calcium Beta-Hydroxybutyrate.
400 mg of Sodium Beta-Hydroxybutyrate.
These softgels are dairy-free, gluten-free, and keto-friendly.
Other ingredients: L-Leucine, Gelatin, Microcrystalline Cellulose, Silicon Dioxide, and Ascorbyl Palmitate.
Product Safety:
Active Ingredients (per daily dose of 2 servings / 4 capsules):
Calcium Beta-Hydroxybutyrate – 800 mg daily
Safety Profile: Generally considered safe for oral consumption. Often used in ketogenic supplements to elevate blood ketone levels.
Common Side Effects: May include mild gastrointestinal discomfort such as bloating, diarrhea, or stomach upset at higher doses.
Sodium Beta-Hydroxybutyrate – 800 mg daily
Safety Profile: Also widely used in exogenous ketone supplements. The sodium form helps with electrolyte balance during ketosis.
Common Side Effects: Similar to calcium BHB—GI discomfort, and in very high doses, potential for elevated sodium intake.
Inactive Ingredients:
L-Leucine
Safety Profile: An essential branched-chain amino acid that supports muscle synthesis. Considered safe in standard supplement doses.
Common Side Effects: Rare at low levels, though high doses may cause fatigue or impaired coordination in some individuals.
Gelatin
Safety Profile: Used to form softgel capsules; generally safe for most people.
Common Side Effects: In some cases, may cause bloating, burping, or a heavy feeling in the stomach.
Microcrystalline Cellulose
Safety Profile: Commonly used as a filler or binder in supplements. It is inert and not absorbed by the body.
Common Side Effects: Rare; generally well-tolerated.
Silicon Dioxide
Safety Profile: Functions as an anti-caking agent. Widely used in the food and supplement industry.
Common Side Effects: None reported at typical intake levels.
Ascorbyl Palmitate
Safety Profile: A fat-soluble form of Vitamin C used as an antioxidant.
Common Side Effects: Generally well tolerated; excessive intake may result in digestive upset.
Overall Safety Summary:
This formulation appears to be safe for general adult use when taken as directed. Mild digestive discomfort is the most commonly reported side effect, particularly with BHB salts. There are no known major safety concerns at the stated dosages, assuming no underlying health issues or contraindications.