Dietary therapy may be beneficial in alleviating symptoms of chronic fatigue syndrome (CFS), a disorder that is characterized by extreme fatigue and other symptoms, but the cause of which remains unclear. The aim of this study was to evaluate the protective effect of a botanical product containing cistanche (Cistanche tubulosa [Schenk] Wight) and ginkgo (Ginkgo biloba L.) extracts on adults with CFS in a randomized, double-blind, placebo-controlled clinical trial. A total of 190 subjects (35–60 years old, non-obese) with CFS were randomized to receive one tablet of a low dose (120-mg ginkgo and 300-mg cistanche), a high dose (180-mg ginkgo and 450-mg cistanche) or a placebo once daily for 60 days. Blood samples and responses on the Chalder fatigue scale (CFQ 11), the World Health Organization's quality of life questionnaire (WHOQOL), and the sexual life quality questionnaire (SLQQ) were collected at baseline and post-intervention. CFS symptoms of impaired memory or concentration, physical fatigue, unrefreshing sleep, and post-exertional malaise were significantly improved (p < 0.001) in both of the treatment groups. The botanical intervention significantly decreased physical and mental fatigue scores of CFQ 11 and improved WHOQOL and SLQQ scores of the subjects (p < 0.01). Levels of blood ammonia and lactic acid in the treatment groups were significantly lower than those of the placebo group (low-dose: p < 0.05; high-dose: p < 0.01). In addition, the change in lactic acid concentration was negatively associated with the severity of CFS symptoms (p = 0.0108) and was correlated with the change in total physical fatigue score of the CFQ (p = 0.0302). Considering the trivial effect size, the results may lack clinical significance. In conclusion, this botanical product showed promising effects in ameliorating the symptoms of CFS. Clinical trials with improved assessment tools, an expanded sample size, and an extended follow-up period are warranted to further validate the findings.Clinical Trial Registration:https://clinicaltrials.gov/, identifier: NCT02807649.

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BackgroundDietary therapy may be beneficial in alleviating symptoms of chronic fatigue syndrome (CFS), a disorder characterized by extreme fatigue with no underlying medical condition. The aim of this study is to evaluate the protective effect of a botanical product containing cistanche (Cistanche tubulosa (Schenk) Wight) and ginkgo (Ginkgo biloba L.) extracts on adults with CFS in a randomized, double-blind, placebo-controlled clinical trial.MethodsA total of 190 subjects with CFS were randomized to receive low dose, high dose of product or placebo (tablets) once daily for 60 days. Blood samples and questionnaires of Chalder fatigue, quality of life (QOL), and sexual life quality (SLQ) were collected at baseline and post-intervention.ResultsOur product significantly relieved the symptoms of CFS, among which impaired memory or concentration, muscle pain, unrefreshing sleep, and post-exertional malaise were significantly improved. The intervention of product significantly decreased both physical and mental fatigue scores of the Chalder fatigue questionnaire, and improved QOL and SLQ of the subjects. Levels of blood ammonia and lactic acid in the subjects of product group were significantly lower than those of placebo group. In addition, the change in lactic acid concentration was significantly associated with the effectiveness for CFS symptoms, and correlated to the change in total physical fatigue score of the Chalder fatigue questionnaire.ConclusionsOur botanical product relieves the CFS symptoms and improves the scores of Chalder fatigue, QOL and SLQ questionnaires. These findings suggest a nutritional supplementation approach with botanical extracts as an alternative strategy in mitigating CFS.Trial registrationThis trial has been registered on https://clinicaltrials.gov/ under the identification code: NCT02807649. Registered 21 June 2016 - Retrospectively registered.

The release characteristics of a unique blend of carotenoid beadlets designed to increase bioavailability were tested using the dynamic gastrointestinal model TIM‐1. Individual carotenoid bioaccessibility peaks were observed over approximately 3–4 hr in the order of lutein and zeaxanthin first, followed by lycopene, and then finally α‐ and β‐carotene; when tested as a beadlet blend or when the beadlets were compressed into tablets. Bioaccessibility measurements of 7%–20% were similar to those previously reported in literature and comparable between the two formulations, beadlet blend and tablet formulations. Total recovery of carotenoids from all compartments ranged from 70% to 90% for all carotenoids, except lycopene where almost 50% was unrecoverable after digestion in the TIM system.

Carotenoids are implicated as beneficial substances in human health yet human dietary intakes are repeatedly shown to be inadequate to current health recommendations. It may be useful to provide a balanced, naturally derived, mixed carotenoid supplement to address the widespread deficits in carotenoid consumption. However, when mixed carotenoids are delivered into the intestinal tract together considerable competition occurs for micelle formation and subsequent intestinal absorption, affecting the bioavailability of the compounds. Previously we have demonstrated a mixed carotenoid formulation that can release individual carotenoids in a sequential structure over the transit time of the human upper gastrointestinal system (6 hours). We hypothesized that temporally separating the individual carotenoids would reduce competition for micelle formation, improve uptake, and maximize efficacy. Here, we test this hypothesis by evaluating the change of carotenoid levels in the plasma chylomicron fraction for 8 hours after oral doses of a sequential release mixed carotenoid formulation in comparison to a matched conventional release formulation, in a randomized, double blind, repeated measure, cross‐over study in adult humans. We find the carotenoid change from baseline area under the curve (AUC) is more favorable following consumption of the sequential release format over that seen following the conventional release. Spearman’s correlation analysis also demonstrates less interaction and regulation between the sequentially spaced carotenoids, suggesting improved bioavailability from a novel sequential release mixed carotenoid formulation. Grant Funding Source: Supported by Amway Corporation