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The effect of synbiotic supplementation on hypothyroidism: A randomized double-blind placebo controlled clinical trial.
Ramezani, M, Reisian, M, Sajadi Hezaveh, Z
PloS one. 2023;18(2):e0277213
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Despite the increased awareness and the improvements in medical management of hypothyroidism; depression, mood disturbance and poor health-related quality of life (QoL) is common among hypothyroid patients. Synbiotics have been advocated as being beneficial to patients with metabolic diseases. Synbiotics are a mixture of probiotics and prebiotics that beneficially affect the host by improving the survival and stimulating the growth of advantageous and health promoting microbial species in the gastrointestinal tract. The aim of this study was to examine whether synbiotic supplementation could enhance depression, QoL, and blood pressure, as well as thyroid hormones in hypothyroid patients. This study is a 10-week parallel design randomised placebo-controlled trial. Participants – adults with hypothyroidism - were randomly assigned to the synbiotic (n = 28) or the placebo (n = 28) group. Results show that following 10 weeks supplementation with synbiotics (500 mg of 10⁹ CFU/g probiotics plus fructo-oligosaccharide) in comparison to placebo does not affect serum thyroid stimulating hormone level and depression. However, it significantly improved blood pressure levels and various domains and areas of QoL. Authors conclude that further clinical trials are needed to assess the effectiveness of a synbiotic supplementation along with the current routine treatment for hypothyroid patients.
Abstract
OBJECTIVE We hypothesize that synbiotic supplementation could modulate the intestinal microbiota and subsequently, improve the condition of hypothyroid patients. METHODS Fifty-six adult hypothyroid patients were recruited to this double-blind, placebo-controlled, randomized clinical trial. The intervention was 10 weeks of synbiotic (500 mg of 109 CFU/g probiotics plus fructo-oligosaccharide, n = 28) compared to placebo (lactose, magnesium stearate, talc, and silicon dioxide, n = 28). Randomization and allocation to trial groups were carried out using random number sequences drawn from https://sealedenvelope.com/. Primary outcomes were serum thyroid stimulating hormone (TSH) and free thyroxine (FT4), and secondary outcomes were depression, quality of life, and blood pressure (BP). P-values< 0.05 were considered statistically significant. RESULTS Analysis on 51 patients who completed the trial showed that TSH and depression (p> 0.05) did not change significantly, while serum FT4 significantly increased in both groups (p = 0.03 and p = 0.02 in symbiotic and placebo respectively). A significant decrease in systolic BP occurred only in the synbiotic group (p = 0.05). Significant improvements occurred regarding different domains and areas of quality of life in the crude and adjusted analysis, including perceived mental health (p = 0.02), bodily pain (p = 0.02), general health perception (p = 0.002), and wellbeing (p = 0.002), which were significantly higher in the synbiotic group. CONCLUSIONS Ten-week supplementation with synbiotic had no favorable effect on depression and TSH, but it improved blood pressure and quality of life in patients with hypothyroidism. More trials are needed to support or reject these findings. TRIAL REGISTRATION IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 1st, 2021.
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The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial.
Le Sayec, M, Xu, Y, Laiola, M, Gallego, FA, Katsikioti, D, Durbidge, C, Kivisild, U, Armes, S, Lecomte, M, Fança-Berthon, P, et al
Clinical nutrition (Edinburgh, Scotland). 2022;41(11):2549-2561
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Over the last decades, Aronia melanocarpa, or black chokeberry, has gained increased attention for its high content of (poly)phenols, and potential protection against chronic diseases such as cardiovascular disease and diabetes. The aim of this study was to investigate the effects of 12-week aronia berry (poly)phenol consumption on cardiometabolic health and gut microbiome composition in prehypertensive middle-aged adults. This study was a 2-arm, double-blind, parallel randomised controlled trial. Participants (n = 102; 47 men and 55 women) were assigned randomly to Aronia or control groups. Results showed that there were no significant effects in blood pressure (primary outcome), endothelial function or blood lipids. However, there was a significant improvement in 24-hour ambulatory arterial indices and significant changes in gut microbiome richness, functions and composition between Aronia and control groups. Authors conclude that future studies should be conducted to investigate whether aronia supplementation may be effective in other at-risk populations such as hypertensives or people with cardiovascular disease risk.
Abstract
BACKGROUND AND AIMS Berry (poly)phenol consumption has been associated with cardioprotective benefits, however little is known on the role the gut microbiome may play on such health benefits. Our objective was to investigate the effects of aronia berry (poly)phenol consumption on cardiometabolic health and gut microbiome richness and composition in prehypertensive middle-aged men and women. METHODS A total of 102 prehypertensive participants were included in a parallel 12-week randomized double-blind placebo-controlled trial. Volunteers were randomly allocated to daily consume an encapsulated (poly)phenol-rich aronia berry extract (Aronia, n = 51) or a matched maltodextrin placebo (Control, n = 51). Blood pressure (BP) and arterial function (office and 24 h), endothelial function (measured as flow-mediated dilation), serum biochemistry (including blood lipids), plasma and urine (poly)phenol metabolites as well as gut microbiome composition through shotgun metagenomic sequencing were monitored over the study period. Relationships between vascular outcomes, (poly)phenol metabolites and gut microbiome were investigated using an integrated multi-levels approach. RESULTS A significant improvement in arterial indices measured as augmentation index (AIx) and pulse wave velocity (PWV) was found in the Aronia compared to Control group (awake Δ PWV = -0.24 m/s; 95% CI: -0.79, -0.01 m/s, P < 0.05; 24 h peripheral Δ AIx = -6.8; -11.2, -2.3, %, P = 0.003; 24 h central Δ AIx = -3.3; -5.5, -1.0, %, P = 0.006). No changes in BP, endothelial function or blood lipids were found following the intervention. Consumption of aronia (poly)phenols led to a significant increase in gut microbiome gene richness and in the abundance of butyrate-producing species such as Lawsonibacter asaccharolyticus and Intestinimonas butyriciproducens species, compared to Control group. Results from an approach including metabolomic, metagenomic and clinical outcomes highlighted associations between aronia-derived phenolic metabolites, arterial stiffness, and gut microbiome. CONCLUSIONS Aronia berry (poly)phenol consumption improved arterial function in prehypertensive middle-aged individuals, possibly via modulation of gut microbiome richness and composition based on the associations observed between these parameters. CLINICAL TRIAL REGISTRY The National Institutes of Health (NIH)-randomized trial records held on the NIH ClinicalTrials.gov website (NCT03434574). Aronia Berry Consumption on Blood Pressure.
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Link between gut microbiota and health outcomes in inulin -treated obese patients: Lessons from the Food4Gut multicenter randomized placebo-controlled trial.
Hiel, S, Gianfrancesco, MA, Rodriguez, J, Portheault, D, Leyrolle, Q, Bindels, LB, Gomes da Silveira Cauduro, C, Mulders, MDGH, Zamariola, G, Azzi, AS, et al
Clinical nutrition (Edinburgh, Scotland). 2020;39(12):3618-3628
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A global obesity epidemic has become a growing concern today. Modifying the microbial population in our gut has been identified as a nutritional intervention strategy for managing obesity. Fermentable dietary fibres such as inulin-type fructans may alter the microbial population in the gut. In this randomised, single-blind, multicentric, placebo-controlled study, researchers examined the effect of 16g/d native inulin supplementation with inulin-rich vegetables on obesity and gut bacteria composition over three months in 106 Caucasian subjects. Furthermore, the study examined the synergistic effects of metformin and inulin on gut microbial composition. 75% of the participants lost body weight after taking inulin and making dietary changes. In addition, BMI, fat mass and other metabolic markers decreased in this group. Combined with inulin, metformin showed gut microbial modulation, although an increase in Bifidobacterium species was less noticeable. Supplementing inulin with inulin-rich vegetables caused uncomfortable side effects such as bloating and flatulence. Even though subjects showed a reduction in side effects after the first month of supplementation, it should be considered when making intervention decisions for people prone to digestive issues. Nutrition practitioners can use these results when developing obesity intervention strategies.
Abstract
BACKGROUND The gut microbiota is altered in obesity and is strongly influenced by nutrients and xenobiotics. We have tested the impact of native inulin as prebiotic present in vegetables and added as a supplement on gut microbiota-related outcomes in obese patients. Metformin treatment was analyzed as a potential modulator of the response. METHODS A randomized, single-blinded, multicentric, placebo-controlled trial was conducted in 150 obese patients who received 16 g/d native inulin versus maltodextrin, coupled to dietary advice to consume inulin-rich versus -poor vegetables for 3 months, respectively, in addition to dietary caloric restriction. Anthropometry, diagnostic imaging (abdominal CT-scan, fibroscan), food-behavior questionnaires, serum biology and fecal microbiome (primary outcome; 16S rDNA sequencing) were analyzed before and after the intervention. RESULTS Both placebo and prebiotic interventions lowered energy intake, BMI, systolic blood pressure, and serum γ-GT. The prebiotic induced greater weight loss and additionally decreased diastolic blood pressure, AST and insulinemia. Metformin treatment compromised most of the gut microbiota changes and metabolic improvements linked to prebiotic intervention. The prebiotic modulated specific bacteria, associated with the improvement of anthropometry (i.e. a decrease in Desulfovibrio and Clostridium sensu stricto). A large increase in Bifidobacterium appears as a signature of inulin intake rather than a driver of prebiotic-linked biological outcomes. CONCLUSIONS Inulin-enriched diet is able to promote weight loss in obese patients, the treatment efficiency being related to gut microbiota characteristics. This treatment is more efficacious in patients who did not receive metformin as anti-diabetic drugs prior the intervention, supporting that both drug treatment and microbiota might be taken into account in personalized nutrition interventions. Registered under ClinicalTrials.gov Identifier no NCT03852069.