scholarly journals Effect of Fat and Fasting on Post-Prandial Relative Bioavailability of Vitamin E

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1797-1797
Author(s):  
Ifechukwude Ebenuwa ◽  
Pierre-Christian Violet ◽  
Hongbin Tu ◽  
Mark Levine
Keyword(s):  
Vitamin E ◽  
Area Under The Curve ◽  
Relative Bioavailability ◽  
Breakfast Meal ◽  
Healthy Women ◽  
Funding Sources ◽  
Clinical Research Center ◽  
Serial Sampling ◽  
Group 12 ◽  
Fast Group

Abstract Objectives We hypothesized that meal fat co-administered with fat-soluble α-tocopherol (vitamin E) facilitates vitamin E absorption and increases relative bioavailability in the immediate post-prandial phase, when compared with non-fat meals. We tested this hypothesis using deuterated oral α-tocopherol co-administered with breakfast containing meal fat (40% group) and without meal fat (0% group) in hospitalized healthy women. We also evaluated the role of subsequent meals in modulating the vitamin E relative bioavailability by fasting patients for 12 h following a breakfast meal with 0% fat (0% fat-fasting group). We compared area under the curve (AUC) for oral d3-α-tocopherols %enrichment at 0–4 h, 0–12 h and 0–24 h. Methods Custom-synthesized deuterated d3-α-tocopherol was co-administered with breakfast meal with and without fat, with subsequent serial sampling. Enrolled subjects were healthy women hospitalized for 5–6 days at the NIH Clinical Research Center. Results The AUC0–4 h for 40% fat group was more than twice 0% fat group (6.4 ± 1.8 vs 2.3 ± 0.7). This difference was erased following ingestion of meals containing 30% fat at 4 h and 8 h post-dosing, with AUC0–12 h for 40% and 0% fat groups (96.8 ± 10.2 vs 107.4 ± 8.) and AUC0–24 h (254 ± 16.3 vs 301.8 ± 19.7). To evaluate the effect of fasting, we compared 0% fat group with 0% fat-fast groups. At 4 h and 8 h post-dosing, the 0% fat group received meals with 30% fat, while 0% fat-fast group remained in fasting state. We therefore predicted and found significantly higher AUC0–12 h in the 0% fat group compared with the 0% fat-fast (107.4 ± 8.1 vs 41.1 ± 5.2 P < 0.001). Following meal consumption by 0% fat-fast group 12 h post-dosing, AUC0–24 h between 0% fat and 0% fat-fast groups narrowed but remained significantly different (301.8 ± 19.7 vs 207.4 ± 10.6, P < 0.002) respectively. Conclusions Findings demonstrate the effect of meal fat in facilitating vitamin E absorption in the immediate post-prandial state, resulting in increased relative bioavailability. Conversely, fasting decreases vitamin E relative bioavailability. Funding Sources NIDDK Intramural Program.

Bioequivalence of Two Methotrexate Formulations in Psoriatic and Cancer Patients

1993 ◽  
Vol 27 (12) ◽  
pp. 1434-1438 ◽  
Author(s):  
Mary E. Teresi ◽  
Charles E. Riggs ◽  
Paul M. Webster ◽  
Michael J. Adams ◽  
Patrick K. Noonan ◽  
...  
Keyword(s):  
Peak Concentration ◽  
Area Under The Curve ◽  
Relative Bioavailability ◽  
University Hospital ◽  
Brand Name ◽  
Mean Values ◽  
Time To Peak ◽  
Clinical Research Center ◽  
Percent Rate ◽  
Randomized Crossover Study

OBJECTIVE: To compare the bioequivalence of a generic methotrexate (MTX) tablet (Mylan) with that of a brand-name (Lederle) product. DESIGN: A single-dose, randomized, crossover study. SETTING: Clinical Research Center (CRC) at a university hospital. PATIENTS: Men and women who had a diagnosis of malignancy or psoriasis who were at least 21 years old. METHODOLOGY: Two overnight study periods were scheduled at the CRC at least one week, but not more than two weeks apart. Each period consisted of a 10-hour fast prior to and 4 hours following oral MTX 15 mg administered as six 2.5-mg tablets. Blood samples were collected over 48 hours. Plasma MTX concentrations were determined using an HPLC assay. Area under the curve from zero to infinity (AUC0-∞) was calculated by the log-trapezoidal method. RESULTS: Twenty-two patients (21 psoriasis, 1 colon cancer) aged 23–61 years completed both study periods. Mean values for peak concentration, time to peak concentration, and AUC0-∞ were 0.80 μmol/L, 1.2 hours, and 3.0 μmol•h/L, respectively, for Mylan's MTX tablets and 0.81 μmol/L, 1.4 hours, 3.0 μmol•h/L, respectively, for Lederle's MTX. Normalization for weight or body surface area did not affect interpatient variability. Relative bioavailability of generic MTX was 99.2 percent Rate and extent of absorption were not significantly different and the confidence intervals were within the range of 80–120 percent required by the Food and Drug Administration. CONCLUSIONS: Mylan's MTX tablet is bioequivalent to Lederle's product.

scholarly journals Bioequivalence Study of Two Multivitamin Formulations Containing Vitamin E and Folate in Healthy Adults

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 1331-1331
Author(s):  
Kelly Zhang ◽  
William Hooper ◽  
Andrew Wong ◽  
Malkanthi Evans ◽  
Najla Guthrie Guthrie ◽  
...  
Keyword(s):  
Vitamin E ◽  
Maximum Concentration ◽  
Phase 1 ◽  
Geometric Mean ◽  
Area Under The Curve ◽  
Bioequivalence Study ◽  
Healthy Adults ◽  
Funding Sources ◽  
To Receive ◽  
Previous Pilot Study

Abstract Objectives Bioequivalence of vitamin E and folate in a single oral dose multivitamin (MVI) gummy or tablet. Methods This crossover clinical trial involved healthy adults randomized to either gummy or tablet MVI containing vitamin E (VE – 279 IU gummy; 239 IU tablet) and folate (1860 µg gummy; 1877 µg tablet) as a single dose in Phase 1 with blood samples collected at pre-dose and 0.5-, 1-, 2-, 4-, 6-, 8-, 9-, 10-, 24-, and 48-hours after dosing, followed by a 2-week washout period. In Phase 2, participants crossed over to receive MVI in the form not previously given, with blood draws at the same timepoints. Maximum Concentration (Cmax), Time of Maximum Concentration (Tmax), and Area Under the Curve (AUC) were calculated for each subject for both vitamin forms. Bioequivalence for AUC, Tmax, and Cmax was defined as a 90% confidence interval (CI) for the gummy to tablet comparator ratio of the geometric mean between 80% and 125%. Results Nineteen participants completed the study. Both gummy and tablet demonstrated absorption for both vitamins. The ratio of geometric means demonstrated bioequivalence between gummy and tablet for both VE and folate with both AUC and Cmax. While bioequivalence was also demonstrated for VE with Tmax, folate absorption peaked earlier in the gummy group (Tmax 1.89 hrs) than the tablet group (Tmax 4.00 hrs), shifting Cmax values in the gummy group to earlier timepoints than in the tablet group without affecting total absorption AUC. These results were consistent with a previous pilot study. Conclusions Overall, under the conditions of this study, both gummy and tablet showed similar absorption of vitamin E and folate. Funding Sources Church & Dwight Co., Inc.

scholarly journals Bioavailability of Iron, Zinc, Folate, and Vitamin C in the Iris Multi-Micronutrient Supplement: Effect of Combination with a Milk-Based Cornstarch Porridge

2003 ◽  
Vol 24 (3_suppl_1) ◽  
pp. S20-S26 ◽  
Author(s):  
Fernanda Kamp ◽  
Doris Jandel ◽  
Imke Hoenicke ◽  
Klaus Pietrzk ◽  
Rainer Gross ◽  
...  
Keyword(s):  
Vitamin C ◽  
Test Meal ◽  
Area Under The Curve ◽  
Relative Bioavailability ◽  
Crossover Design ◽  
Healthy Women ◽  
Over Time

The effect of combining a multi-micronutrient supplement with a milk-based cornstarch porridge on the bioavailability of iron, zinc, folate, and vitamin C was evaluated using the plasma curve response over time (8 hours) in healthy women. Three tests were carried out in a crossover design: S (multi-micronutrient supplement), MS (multi-micronutrient supplement plus test meal), and M (test meal). Relative bioavailability was determined as the percent ratio of the area under the curve (AUC) in MS corrected by M, and AUC in S. Compared to S, AUC in MS was smaller for iron (p < .05), for zinc (p < .01), and for folate (p < .05), but not different for vitamin C. Relative bioavailability was lower (p < .05) than 100% for iron (80%), zinc (70%), and folate (85%). The decrease in bioavailability of these nutrients when the multi-micronutrient supplement is combined with a milk-based cornstarch porridge is small. Therefore, the tested meal is a suitable vehicle for the multi-micronutrient supplement.

scholarly journals Emulsification by TPGS or Quillaja Extract Increased Absorption and Affected Metabolism of Berberine in Humans

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 381-381
Author(s):  
Yavuz Yagiz ◽  
Gary Wang ◽  
Liwei Gu
Keyword(s):  
Peak Plasma ◽  
Peak Plasma Concentration ◽  
Area Under The Curve ◽  
Total Content ◽  
Compartment Model ◽  
Analysis Of Covariance ◽  
High Tech ◽  
Pharmacokinetic Parameters ◽  
Funding Sources ◽  
Human Volunteers

Abstract Objectives Berberine is a botanical alkaloid used widely for the prevention of several diseases. However, the absorption rate of berberine is less than 1% in human. The objectives of this study were to determine whether emulsification by TPGS or Quillaja extract affect the absorption and metabolism of orally ingested berberine in human volunteers. Methods Twelve healthy subjects (7 male and 5 females, 21–50-year-old) participated this study. Each subject received 800 mg berberine in a powder form or emulsified with TPGS or Quillaja extract using a randomized crossover design with one-week washout period. Blood samples were collected at 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours after dose. Plasma was hydrolyzed with glucuronidase and sulfatase before total content of berberine and its metabolites were analyzed on LC/MS/MS. Free forms of metabolites were determined in plasma without hydrolysis. Pharmacokinetic parameters were calculated using a non-compartment model before they were compared by analysis of covariance. Results The area under the curve (AUC) and peak plasma concentration (Cmax) of berberine was 6.6 μM.hr and 0.9 μM in participants received berberine powder. They were increased to 18.3 μM.hr and 4.5 μM by TPGS emulsification and 28 μM.hr and 5.1 μM by Quillaja extract emulsification, respectively. Berberrubine and demethylberberine were major metabolites of berberine. The AUC of free Berberrubine and demethylberberine was increased by 1.9 fold and 1.6 fold by TPGS and 5.9 folds and 2.7 folds by Quillaja extract, respectively, compared to berberine powder. Participants received berberine powder had AUC of 254 μM.hr and Cmax of 33 μM for total berberrubine. TPGS emulsification increased these values to 425 μM.hr and 54 μM, while Quillaja extract increased them to 341 μM.hr and 44 μM, respectively. Significant increases of AUC and Cmax were also observed for total demethylberberine by TPGS or Quillaja extract emulsification. Conclusions Emulsification of berberine with TPGS or Quillaja extract significantly increased the absorption of berberine and its metabolites in human compared to berberine supplement without emulsifiers. Funding Sources Florida High Tech Corridor Council and Designs for Health.

scholarly journals Preparation, Characterization, and Bioavailability of Host-Guest Inclusion Complex of Ginsenoside Re with Gamma-Cyclodextrin

Molecules ◽  
2021 ◽  
Vol 26 (23) ◽  
pp. 7227
Author(s):  
Hui Li ◽  
Guolei Zhang ◽  
Wei Wang ◽  
Changbao Chen ◽  
Lili Jiao ◽  
...  
Keyword(s):  
Inclusion Complex ◽  
Water Solubility ◽  
Area Under The Curve ◽  
Relative Bioavailability ◽  
Docking Studies ◽  
Solubility Parameters ◽  
Phase Solubility ◽  
Scanning Calorimetry ◽  
Ginsenoside Re

This work aimed at improving the water solubility of Ginsenoside (G)-Re by forming an inclusion complex. The solubility parameters of G-Re in alpha (α), beta (β), and gamma (γ) cyclodextrin (CD) were investigated. The phase solubility profiles were all classified as AL-type that indicated the 1:1 stoichiometric relationship with the stability constants Ks which were 22 M−1 (α-CD), 612 M−1 (β-CD), and 14,410 M−1 (γ-CD), respectively. Molecular docking studies confirmed the results of phase solubility with the binding energy of −4.7 (α-CD), −5.10 (β-CD), and −6.70 (γ-CD) kcal/mol, respectively. The inclusion complex (IC) of G-Re was prepared with γ-CD via the water-stirring method followed by freeze-drying. The successful preparation of IC was confirmed by powder X-ray diffraction (XRD), Fourier transform-infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM). In-vivo absorption studies were carried out by LC-MS/MS. Dissolution rate of G-Re was increased 9.27 times after inclusion, and the peak blood concentration was 2.7-fold higher than that of pure G-Re powder. The relative bioavailability calculated from the ratio of Area under the curve AUC0–∞ of the inclusion to pure G-Re powder was 171%. This study offers the first report that describes G-Re’s inclusion into γ-CD, and explored the inclusion complex’s mechanism at the molecular level. The results indicated that the solubility could be significantly improved as well as the bioavailability, implying γ-CD was a very suitable inclusion host for complex preparation of G-Re.

scholarly journals Stinging Nettle (Urtica simensis) as Potential Resource of Vitamin E

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1815-1815
Author(s):  
Tibebeselassie Keflie
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Vitamin E ◽  
High Performance ◽  
Wild Plant ◽  
Stinging Nettle ◽  
Funding Sources ◽  
Potential Resource ◽  
Central Highlands ◽  
Different Parts

Abstract Objectives The aim of the current study was to assay the content of vitamin E in stinging nettle (Urtica simensis) Methods Urtica simensis type of stinging nettle is an indigenous wild plant which is widely growing in different parts of Ethiopia. Samples of leaves were collected from Chacha, one of the central highlands in Ethiopia and portioned into sun dried, shade dried and lyophilized groups. For comparison, samples of leaves were also taken from spinach. Vitamin E family such as tocopherols ((α, β, γ, and λ) and tocotrienols (α, β, γ, and λ) were determined using high performance liquid chromatography (HPLC) at department of Food Biofunctionality, University of Hohenheim, Stuttgart, Germany. Results The results showed that the total tocols of stinging nettle in sun-dried, shade dried, and lyophilized groups were 14.1 ± 1.1 mg, 13.8 ± 1.1 mg and 16.9 ± 1.2 mg per 100 g, respectively. In spinach, this value was 3.04 ± 0.7 mg/100 g. Of all vitamin E family, α- tocopherol was the maximum and identified in shade dried group (16.5 ± 1.2 mg/100 g). As compared to stinging nettle, spinach contained very small amount of α- tocopherol (1.7 ± 0.5 mg/100 g). Conclusions In conclusion, Urtica simensis type of stinging nettle contains considerable amount of tocols and can serve as potential resource of vitamin E. Further research is warranted on the nutritional and medicinal values of Urtica simensis stinging nettle. Funding Sources None.

scholarly journals Catechin Bioavailability Is Reduced in Obese Persons Without Altering Gut Microbial-Derived Valerolactones Following Consumption of a Green Tea Extract Confection

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 468-468
Author(s):  
Geoffrey Sasaki ◽  
Yael Vodovotz ◽  
Zhongtang Yu ◽  
Richard Bruno
Keyword(s):  
Green Tea ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Relative Bioavailability ◽  
Green Tea Extract ◽  
Maximum Plasma ◽  
Gut Permeability ◽  
Epicatechin Gallate ◽  
Obesity Status ◽  
Tea Extract

Abstract Objectives Green tea extract (GTE) protects against obesity in rodents by reducing gut permeability that otherwise provokes endotoxemia-mediated inflammation. However, whether obesity affects catechin bioavailability and microbial metabolism is unknown. We hypothesized that obesity will reduce catechin bioavailability by increasing microbial biotransformation of catechins. Methods Obese persons (n = 10 M/7F; 33.5 ± 0.7 kg/m2) and age-matched healthy persons (n = 10 M/9F; 21.7 ± 0.4 kg/m2) completed a pharmacokinetics (PK) trial in which a GTE confection [290 mg epigallocatechin gallate (EGCG), 87 mg epigallocatechin (EGC), 39 mg epicatechin (EC), 28 mg epicatechin gallate (ECG)] was ingested prior to collecting plasma at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, and 12 h and urine from 0–4, 4–8, 8–12, and 12–24 h. Stool samples were collected and gut permeability was assessed prior to the 12-h PK trial. Plasma and urinary catechin/catechin-derived microbial metabolites were assessed following enzymatic hydrolysis by LC-MS. Results Regardless of health status, relative bioavailability, based on plasma area under the curve (AUC0–12 h), of GTE catechins were: EGCG &gt; EGC &gt; ECG &gt; EC. However, obese persons had 24–27% lower plasma AUC0–12 h for the four catechins compared to lean persons (P &lt; 0.05). They also had 18–36% lower maximum plasma concentrations (Cmax) of GTE catechins but 12 h plasma catechin concentrations were unaffected by obesity status (P &gt; 0.05). 3ʹ,4ʹ-γ-valerolactone (3,4-VL) was detected in the plasma of all participants, while 3ʹ,4ʹ,5ʹ-γ-valerolactone (3,4,5-VL) was detected in 74% and 82% of lean and obese persons, respectively. Plasma AUC0–12 h for these VL metabolites did not differ by obesity status. EGC, EC, 3,4-VL, and 3,4,5-VL, but not EGCG and ECG, were primarily present in urine and urinary total VLs were increased compared with total urinary catechins. However, 24-h urinary excretion of catechins and VLs were unaffected by obesity. Conclusions Obesity reduces GTE catechin bioavailability and Cmax independent of any change in VL metabolite appearance or urinary elimination of catechins, suggesting a gut-level mechanism that limits catechin absorption. Funding Sources Supported by USDA-NIFA and the Foods for Health Discovery Theme at The Ohio State University.

Fish oil supplementation with and without added vitamin E differentially modulates plasma antioxidant concentrations in healthy women

Lipids ◽  
1998 ◽  
Vol 33 (12) ◽  
pp. 1163-1167 ◽  
Author(s):  
E. Turley ◽  
J. M. W. Wallace ◽  
W. S. Gilmore ◽  
J. J. Strain
Keyword(s):  
Vitamin E ◽  
Fish Oil ◽  
Healthy Women ◽  
Plasma Antioxidant ◽  
Fish Oil Supplementation

scholarly journals Krill Oil Has Different Effects on the Plasma Lipidome Compared with Fish Oil Following 30 Days of Supplementation in Healthy Women: A Randomized Controlled and Crossover Study

Nutrients ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2804
Author(s):  
Hyunsin H. Sung ◽  
Andrew J. Sinclair ◽  
Kevin Huynh ◽  
Adam A. T. Smith ◽  
Natalie A. Mellett ◽  
...  
Keyword(s):  
Fish Oil ◽  
Area Under The Curve ◽  
Krill Oil ◽  
Omega 3 ◽  
Lipidomic Analysis ◽  
Randomized Controlled ◽  
Healthy Women ◽  
Lipid Molecular Species ◽  
Long Chain

This is a follow-up of our previous postprandial study and it focused on the plasma lipidomic responses to 30 days of krill oil (KO) versus fish oil (FO) supplementations in healthy women. Eleven women (aged 18–50 years) consumed KO or FO for 30 days in a randomized, cross-over study, with at least a four-week washout period between supplementations. The daily supplements provided 1.27 g/day of long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA)) and 1.44 g/day from FO (containing 0.79 g EPA, 0.47 g DHA). Fasting plasma samples at days 0, 15, and 30 were analyzed using gas chromatography and liquid chromatography electrospray ionisation-tandem mass spectrometry. KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days. Lipidomic analysis showed that 26 of 43 lipid molecular species had a significantly greater relAUC in the KO group, while 17/43 showed a significantly lower relAUC compared with the FO group. More than 38% of the lipids species which increased more following KO contained omega-3 PUFA, while where FO was greater than KO, only 12% contained omega-3 PUFA. These data show that KO and FO do not have equivalent effects on the plasma lipidome.

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