Ketogenic Composition BDO BHB Ratio for Stable Blood Levels
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Solution Overview
Problem
Existing ketone and ketogenic precursor compositions fail to effectively manage the speed and duration of achieving optimal therapeutic ketosis, often leading to rapid spikes and crashes in D-BHB blood levels, which can cause adverse physiological and gastrointestinal effects, and do not adequately address the risk of exceeding safe ketosis bounds.
Innovation Solution
Compositions combining 1,3-butanediol (BDO) with beta-hydroxybutyric acid (BHB) in specific weight ratios, providing a sustained release of D-BHB within the optimal therapeutic range of 1 to 2.5 mM, mitigating the risk of excessive ketosis and improving palatability and gastrointestinal distress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If high doses of BHB are administered to achieve ketosis, then D-BHB blood concentration increases, but the risk of exceeding safe ketosis bounds and causing adverse physiological effects increases
Solution Approach 1:
The patent employs a two-phase dosing regimen that dynamically adjusts BHB administration: an initial higher dose to rapidly achieve therapeutic ketosis (1.0-3.0 mM), followed by a reduced maintenance dose to sustain levels within the safe therapeutic range. This dynamic approach prevents sustained exposure to potentially harmful high concentrations while ensuring rapid therapeutic effect.
Solution Approach 2:
The patent incorporates a preliminary loading phase where a higher dose of BHB (0.5-2.0 g/kg body weight) is administered first to quickly elevate D-BHB blood concentrations into the therapeutic range, followed by maintenance dosing. This preliminary action ensures rapid achievement of therapeutic effect before transitioning to safer sustained levels.
2Speed
If rapid spike in D-BHB levels is achieved, then speed of entering ketosis improves, but GI distress and nausea increase
Solution Approach 1:
The patent uses dynamic dosing where the rate and amount of BHB administration are adjusted over time: an initial rapid phase to quickly achieve therapeutic ketosis, followed by a slower maintenance phase. This dynamic approach satisfies the need for rapid onset while preventing the sustained rapid spikes that cause GI distress.
Solution Approach 2:
The patent implements periodic dosing schedules with distinct phases: an initial loading phase followed by maintenance phases with lower doses. This periodic structure allows rapid entry into ketosis during the loading phase while preventing excessive and prolonged spikes that would cause gastrointestinal adverse effects.
3Manufacturing precision
If precise control of D-BHB concentration within 1-3.0 mM range is maintained, then optimal therapeutic ketosis is achieved, but dosing regimen complexity increases
Solution Approach 1:
The patent divides the dosing regimen into distinct segments: an initial loading phase with higher doses (0.5-2.0 g/kg) followed by maintenance phases with lower doses (0.1-0.5 g/kg). This segmentation simplifies the overall regimen by breaking down precise concentration control into manageable phases with clear dosing guidelines for each segment.
Solution Approach 2:
The patent employs parameter changes by adjusting the dose amount based on the phase of treatment: higher doses during the loading phase to rapidly achieve therapeutic levels, and lower doses during maintenance to sustain levels within the 1.0-3.0 mM range. This parameter-based approach simplifies control by providing clear dosing parameters for each phase rather than requiring continuous fine-tuning.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The compositions enable rapid entry and sustained maintenance of optimal therapeutic ketosis within the desired range, reducing the risk of adverse effects and eliminating the need for complex dosing regimens, while improving tolerability and duration of ketosis.
Implementation Method 1
1,3-butanediol (BDO), which is converted by the body to D-beta-hydroxybutyric acid (D-BHB)
Data Source
AI summary
Nutritional compositions contain a mixture of ketogenic ingredients including from 80 to 99% weight % 1,3-butanediol (BDO), preferably R-1,3-butanediol, and from 1 to 20 weight % beta-hydroxybutyric acid (BHB), preferably D-beta-hydroxybutyric acid, or an equivalent molar amount of its conjugate base beta-hydroxybutyrate, salts, monoesters, polyesters, or mixtures thereof. In some embodiments, the nutritional compositions for providing ketosis are prepared for oral administration in a solid form, such as bars, bites, tablets, pills or capsules, in a liquid form, such as smoothies, goos, water, carbonated beverages, soft drinks, fermented beverage suspensions, solutions and emulsions, or in a powder form that can be used to prepare drink mixes or can be added as a supplement to other food or drink products. Methods of providing ketosis in a subject include delivering optimal therapeutic ketosis, with rapidity into and extended duration of blood concentrations of D-BHB of between 1 mM and 2.5 mM.