Comparative Bioavailability and Benefits on Mental Functions of Novel Extended-Release Caffeine Capsules against Immediate-Release Caffeine Capsules: An Open-Label, Randomized, Cross-over, Single-Dose Two-Way Crossover Study.
Present study aimed compared pharmacokinetic profile of sustained-release CaffXtend® capsules (SR-Caffeine) with immediate-release caffeine capsules (IR-Caffeine), and the effect of SR-caffeine on memory, motivation, concentration, and attention. This open-label, randomized, single-dose, two-treatme...
| Publicado en: | Journal of Dietary Supplements Vol. 21; no. 1; pp. 13 - 28 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Taylor & Francis Ltd
2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=174725270&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 174725270 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 19390211 2Y62 jtl: Journal of Dietary Supplements issn: 19390211 maglogo: N pubinfo: dt: 2024 vid: 21 iid: 1 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 174725270 161138361 174725270 174725270 10.1080/19390211.2022.2160529 174725270 ppf: 13 ppct: 15 formats: fmt: @attributes: type: P tig: atl: Comparative Bioavailability and Benefits on Mental Functions of Novel Extended-Release Caffeine Capsules against Immediate-Release Caffeine Capsules: An Open-Label, Randomized, Cross-over, Single-Dose Two-Way Crossover Study. aug: au: Thanawala, Shefali Shah, Rajat Abiraamasundari, R. Senthurselvi, R. Desomayanandam, Prabakaran affil: Nutriventia Limited Mumbai, Andheri, Maharashtra, India sug: subj: Caffeine Administration and Dosage Caffeine Adverse Effects Delayed-Action Preparations Adverse Effects Capsules Caffeine Pharmacokinetics Memory Motivation Attention Drug Efficacy Human Cross Sectional Studies Randomized Controlled Trials Random Assignment Crossover Design India Visual Analog Scaling Blood Specimen Collection Descriptive Statistics Confidence Intervals Affect Mental Fatigue Data Analysis Software Anthropometry Food Intake Questionnaires Caffeine Blood Plasma Analytic Sample Preparation Methods Liquid Chromatography-Mass Spectrometry Autoanalysis Analysis of Variance Adult Headache Dietary Supplementation Funding Source Adult: 19-44 years ab: Present study aimed compared pharmacokinetic profile of sustained-release CaffXtend® capsules (SR-Caffeine) with immediate-release caffeine capsules (IR-Caffeine), and the effect of SR-caffeine on memory, motivation, concentration, and attention. This open-label, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover oral bioavailability study block randomized (1:1) healthy subjects (N = 15) to receive SR-Caffeine (200 mg) and IR-Caffeine (200 mg). Blood samples were collected at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 h in each period. Primary study outcome included comparing relative bioavailability of SR-Caffeine 200 mg and IR-Caffeine 200 mg under fasting conditions, and changes in caffeine research visual analogue scale (Caff-VAS) scores ('relaxed', 'alert', 'jittery', 'tired', 'tense', 'headache', 'overall mood' and 'mentally fatigued') were also evaluated. Fifteen subjects completed the study. Mean tmax was 4.08 ± 2.13h for SR-Caffeine compared to 0.83 ± 0.39h for IR-Caffeine, (p < 0.0001). Similarly, mean t½ was 7.07 ± 3.48h for SR-Caffeine compared to 5.78 ± 2.11h for IR-Caffeine (p = 0.04189). However, total exposure was similar for SR-Caffeine and IR-Caffeine (90% CI: 89.89-120.50% to 94.49-123.82% for geometric least square mean of ln-transformed AUC0-t and AUC0-∞). In the Caff-VAS evaluation, the SR-Caffeine group showed significantly better scores for 'jitteriness', 'tiredness', 'alertness' and 'overall mood' for 8-12 h than the IR-Caffeine group. No adverse events were reported. Results demonstrated sustained release of caffeine over 24 h from SR-Caffeine as compared to IR-Caffeine, which showed significant improvements in the scores for 'relaxed', 'alertness' and 'overall mood' and significantly lower scores for the parameters-'jittery' and 'tired' for extended period. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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