Authors
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Purpura, Martin -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: Four curcumin supplement formulations were used (BCM‐95® [Dolcas], Meriva® [Indena], C3 ComplexTM [Sabinsa Corporation] and CAVAMAX® W8 Curcumin/CAVACURMIN® [Wacker Chemie AG]. All volunteers were supplemented with visually identical 6 hard gel capsules of each of the four study materials per setting, resulting in 376 mg of total curcuminoids for CAVAMAX® W8 Curcumin/CAVACURMIN®, BCM‐95® and Meriva® and 1,800 mg of total curcuminoids for StdC (C3 ComplexTM) in accordance with the study dosage established by Cuomo et al. Each dose was separated by a washout period of at least 7 days and blood plasma curcumin levels were assessed continuously for 12 hours following each treatment. First the baseline blood sample was obtained, followed by one of four treatment dosages of curcumin which were consumed with water. Further blood samples were then drawn at the time points of 1, 2, 3, 4, 5, 6, 8 and 12 hours following product supplementation. Each time after the 4‐hour and 8‐hour blood sample draw, a low‐fat and turmeric‐free standardized meal was delivered. All subjects completed 4 trials with 9 blood draws each in a randomized, double‐blinded order. Blood plasma samples were analyzed by tandem mass spectrometry detection to determine curcumin, demethoxycurcumin, and bisdemethoxycurcumin and tetrahydrocurcumin levels. CONDITION: Nutritional supplement ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: 1. Peak plasma concentrations Tmax (h); 2. Area under the plasma concentration time‐curve (AUC 0‐12), Cmax (ng/mL) and T1/2 (h); ; Plasma levels of curcumin, demethoxycurcumin, bisdemethoxycurcumin and tetrahydrocurcumin will be evaluated at 0, 1, 2, 3, 4, 5, 6, 8 and 12 hours. Peak plasma concentrations (TMax), areas under the plasma concentration‐time curves (AUC0‐12h), Cmax, t1/2 and relative absorption will be calculated. INCLUSION CRITERIA: 1. Healthy individuals 2. Age: 20‐35 years 3. Males and females 4. Participants agreed to sign an informed consent form 5. Participants must be able to perform required testing
Epistemonikos ID: 5496f74e9534f0ae0754e5cd60503dcd75a0b6e7
First added on: Aug 23, 2024