Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study.

BACKGROUND: Curcuminoids from turmeric rhizome have significant health benefits but low bioavailability. OBJECTIVES: To assess the pharmacokinetics of a novel natural turmeric dried colloidal suspension compared with 4 other turmeric formulations (including a standardized extract) at their respective recommended dosages. METHODS: Thirty healthy men and women (18 to 45 y old) were enrolled in a randomized, open-labeled, crossover trial, and sequentially consumed single oral doses of standard turmeric extract (1500 mg), liquid micellar preparation (1000 mg), piperine-curcuminoid combination (1515 mg), phytosome formulation (1000 mg), or the dried colloidal suspension (300 mg). Eleven blood samples were obtained over 24 h, plasma was extracted with or without deconjugation with ß-glucuronidase or sulfatase, and ultra-high-pressure liquid chromatography/tandem MS was used to quantify the 3 parent curcuminoids and 12 metabolites. Classical pharmacokinetics parameters were derived. RESULTS: The total AUC values of unconjugated curcuminoids were highly variable within participants, with no significant differences between formulations. However, the AUC values for total curcuminoids (including all metabolites) showed significant product effects. Indeed, the micellar preparation delivered higher levels of total curcuminoids than any other formulation (8540 ng·h/mL), reaching significance when compared with the dried colloidal suspension and standard extract (6520 and 5080 ng·h/mL, respectively). After dose normalization, both micellar and dried colloidal formulations showed significantly higher AUC levels than the standard extract (respectively 136 and 72.9, compared with 3.7 ng·h/mL/mg). Total curcuminoid absorption levels were also significantly higher for the dried colloidal suspension when compared with either piperine or phytosome formulations. Interestingly, no significant differences were observed between the piperine-curcuminoid combination and the standard extract. No serious adverse events were reported. CONCLUSIONS: The administration of a low dose of the novel natural dried colloidal suspension provided high unconjugated and conjugated curcuminoid absorption, with significant beneficial differences when compared with the high dose of standard extract.This trial was registered at clinicaltrials.gov as NCT03621865.

Attitudes and Expectations of Clinical Research Participants Toward Digital Health and Mobile Dietary Assessment Tools: Cross-Sectional Survey Study.

Background: The adoption of health technologies is key to empower research participants and collect quality data. However, the acceptance of health technologies is usually evaluated in patients or healthcare practitioners, but not in clinical research participants. Methods: A 27-item online questionnaire was provided to the 11,695 members of a nutrition clinical research participant database from the Nantes area (France), to assess (1) participants' social and demography parameters, (2) equipment and usage of health apps and devices, (3) expectations in research setting and (4) opinion about the future of clinical research. Each item was described using frequency and percentage overall and by age classes. A global proportion comparison was performed using chi-square or Fisher-exact tests. Results: A total of 1529 respondents (81.0% women, 19.0% men) completed the survey. Main uses of health apps included physical activity tracking (54.7%, age-related group difference, p < 0.001) and food quality assessment (45.7%, unrelated to age groups). Overall, 20.4% of respondents declared owning a connected wristband or watch. Most participants (93.8%) expected the use of connected devices in research. However, protection of personal data (37.5%), reliability (35.5%) and skilled use of devices (28.5%) were perceived as the main barriers. Most participants (93.3%) would agree to track their food intake using a mobile app, and 80.5% would complete it for at least a week while taking part in a clinical study. Only 13.2% would devote more than 10 min per meal to such record. A majority (60.4%) of respondents would accept to share their social media posts in an anonymous way and most (82.2%) of them would accept to interact with a chatbot for research purposes. Conclusions: Our cross-sectional study suggests that clinical study participants are enthusiastic about all forms of digital health technologies and participant-centered studies but remain concerned about the use of personal data. Repeated assessments are suggested to evaluate the research participant's interest in technologies following the increase in use and demand for innovative health services during the pandemic of COVID-19.

Diet Supplementation with NUTRIOSE, a Resistant Dextrin, Increases the Abundance of Parabacteroides distasonis in the Human Gut.

SCOPE: An imbalance of the gut microbiota ("dysbiosis") is associated with numerous chronic diseases, and its modulation is a promising novel therapeutic approach. Dietary supplementation with soluble fiber is one of several proposed modulation strategies. This study aims at confirming the impact of the resistant dextrin NUTRIOSE (RD), a soluble fiber with demonstrated beneficial health effects, on the gut microbiota of healthy individuals. METHODS AND RESULTS: Fifty healthy women are enrolled and supplemented daily with either RD (n = 24) or a control product (n = 26) during 6 weeks. Characterization of the fecal metagenome with shotgun sequencing reveals that RD intake dramatically increases the abundance of the commensal bacterium Parabacteroides distasonis. Furthermore, presence in metagenomes of accessory genes from P. distasonis, coding for susCD (a starch-binding membrane protein complex) is associated with a greater increase of the species. This suggests that response to RD might be strain-dependent. CONCLUSION: Supplementation with RD can be used to specifically increase P. distasonis in gut microbiota of healthy women. The magnitude of the response may be associated with fiber-metabolizing capabilities of strains carried by subjects. Further research will seek to confirm that P. distasonis directly modulates the clinical effects observed in other studies.

A Graded Approach for Evaluating Health Claims about Plant-Based Food Supplements: Application of a Case Study Methodology.

The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.

High blood pressure and obesity: disparities among four French Overseas Territories.

BACKGROUND AND PURPOSE: The epidemiological characteristics of hypertension and obesity in French Overseas Territories (FOTs) have never been compared. METHODS: This cross-sectional survey included representative population-based samples of 602, 601, 620 and 605 men and women aged more than 15 years, respectively, from four FOTs of Guadeloupe, Martinique, French Guiana, and French Polynesia. Hypertension was defined as blood pressure (BP) at least 140/90 mmHg or the current use of antihypertensive treatment. RESULTS: The prevalence of hypertension was 29.2% in Guadeloupe, 17.9% in French Guiana, 27.6% in Martinique and 24.5% in French Polynesia. Considering the Guadeloupe population as the reference group, prevalence of hypertension was significantly lower in French Guiana (P < 0.001), even after controlling for age and sex (P = 0.006). Awareness and treatment of hypertension were similar in French Guiana, Martinique and Guadeloupe (68.8-75.1% and 69.0-73.4%, respectively). Awareness was lower in French Polynesia (50.0%, adjusted P value = 0.04), as was treatment of hypertension (32.4%, adjusted P value = 0.001). Control of hypertension was also lower in French Polynesia (8.8%, adjusted P value = 0.001) compared with the other territories (29.7-31.8%). French Polynesia had the highest prevalence of obesity (33.1%, adjusted P value < 0.001) as compared with the other territories (17.9-22.8%). It had also the largest population attributable fraction of hypertension due to obesity (35.5%) compared with Guadeloupe (13.3%), Martinique (12.3%) and French Guiana (23.6%). CONCLUSION: Wide variations were observed in the prevalence and the management of hypertension between these FOTs, and an especially challenging low control of hypertension was found in French Polynesia. Obesity appears a key target to prevent hypertension, particularly in French Polynesia.