Effect of a ß-hydroxybutyrate (D/L) salt based supplement (sodium, calcium) on healthy adults
- Conditions
- healthy subjects
- Registration Number
- DRKS00014091
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
The supplement led to a significant increase of D-ßHB concentration in blood 2.5 and 3 h after oral intake (p=0.033; p=0.043). The first significant effect was measured after 2 h with a mean value of 0.598 ± 0.300 mmol/L at the peak, which was recorded at 2.5 h. Changes in serum electrolytes and BGA were largely unremarkable. Taking the supplement was not without side effects. One subject dropped out due to gastrointestinal symptoms and two others reported similar but milder problems. Conclusions: Intake of a combination of calcium and sodium D-/L-ßHB salt shows a slow resorption with a moderate increase of D-ßHB in serum levels. An influence of ßHB salts on acid-base balance could not be excluded by this one-dose study. Excessive regular consumption without medical observation is not free of adverse effects. The tested product can therefore not be recommended unconditionally.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
18 - 60 years, male/female, no intake of drugs (except contraceptives), no metabolic disease (like Diabetes Typ I / II), no health impairment, no mental or linguitic limitations, no low-carb, vegane, or other nutrition form with a low carbohydrate intake, accepting of informed consent
intake of nutritional supplements with effect on fatty acid metabolism (like MCT), pregnancy and breast feeding period, participation in other studies at the same time, metabolic disease, chronical disease, daily nutrition with low intake of carbohydrates (< 50 E%), blood donation in the last three months, intolerance against flavors and sweeteners (like stevia), psychological illness (depression, schizophrenia, etc.), severe diseases (like cancer), intake of drugs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ß-hydroxybutyrate (mmol/L) in serum at t0 (baseline) and tmax (primary outcome). Measuring over a period of 6 hours every 30 minutes.
- Secondary Outcome Measures
Name Time Method tolerability (self documentation of the subjects, during intervention time), sensory interview (description of taste, odor, color during intake of test solution), blood parameters: glucose (every 30 minutes over 6 h), blood gas analysis (t0, after 3 h and 6 h [end]): sodium, potassium, calcium, pH, hydrogencarbonate