Intervention: Melatonin + L-theanine (Arm 1, n = 13) or caffeine + L-theanine (Arm 2, n = 12). Functional ingredients were administered in either Liquid I.V. Hydration Multiplier or an oral rehydration solution without carbohydrates and electrolytes.
Dosing/administration: Product given in 4 equal volumes within 15 min (every ~3.75 min).
Study Duration: 4 hours
Eligibility Criteria:
1. Healthy male and female participants, aged 18 – 55 years.
2. Body mass index (BMI) of 18.0 to 34.9 kg/m2
For more, plus the exclusion criteria, see:
Key Findings
1.
Liquid I.V. Hydration Multiplier significantly reduced the Tmax for all functional ingredients relative to control, indicating faster absorption. Data from Arm 1 revealed that melatonin and L-theanine absorption was 37% (P = 0.05) and 25% (P = 0.05) faster, respectively. In Arm 2, caffeine and L-theanine absorption was 44% (P = 0.01) and 42% (P = 0.01) faster, respectively.
2.
Although Liquid I.V. Hydration Multiplier modestly improved the total absorption (AUC) of melatonin and L-theanine over the 4-hour study period, these findings were not statistically significant. There were no significant differences in the maximum value of absorption (Cmax) for any of the functional ingredients. Although the AUC and Cmax data did not demonstrate significant improvements, these findings were expected given these were healthy adults with no impaired absorptive functionality.
Table 2. Mean (±SD) concentration maximum (Cmax) and area under the curve (AUC) over 240 min.
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THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
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