Leonurine affected homocysteine‐methionine metabolism based on metabolomics and gut microbiota studies of clinical trial samples

Abstract Purpose To explore whether high intake of cod or salmon would affect gut microbiota profile, faecal output and serum concentrations of lipids and bile acids. Methods Seventy-six adults with overweight/obesity with no reported gastrointestinal disease were randomly assigned to consume 750 g/week of either cod or salmon, or to avoid fish intake (Control group) for 8 weeks. Fifteen participants from each group were randomly selected for 72 h faeces collection at baseline and end point for gut microbiota profile analyses using 54 bacterial DNA probes. Food intake was registered, and fasting serum and morning urine were collected at baseline and end point. Results Sixty-five participants were included in serum and urine analyses, and gut microbiota profile was analysed for 33 participants. Principal component analysis of gut microbiota showed an almost complete separation of the Salmon group from the Control group, with lower counts for bacteria in the Bacteroidetes phylum and the Clostridiales order of the Firmicutes phyla, and higher counts for bacteria in the Selenomonadales order of the Firmicutes phylum. The Cod group showed greater similarity to the Salmon group than to the Control group. Intake of fibres, proteins, fats and carbohydrates, faecal daily mass and output of fat, cholesterol and total bile acids, and serum concentrations of cholesterol, triacylglycerols, non-esterified fatty acids and total bile acids were not altered in the experimental groups. Conclusion A high intake of cod or salmon fillet modulated gut microbiota but did not affect faecal output or serum concentrations of lipids and total bile acids. Clinical trial registration This trial was registered at clinicaltrials.gov as NCT02350595.

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The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial

Nutrition ◽

10.1016/j.nut.2020.110854 ◽

2020 ◽

Vol 79-80 ◽

pp. 110854

Author(s):

Nazila Kassaian ◽

Awat Feizi ◽

Soodabeh Rostami ◽

Ashraf Aminorroaya ◽

Majid Yaran ◽

...

Keyword(s):

Clinical Trial ◽

Gut Microbiota ◽

Randomized Clinical Trial ◽

Double Blind

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Effect of Vitamin D Supplementation on Faecal Microbiota: A Randomised Clinical Trial

Nutrients ◽

10.3390/nu11122888 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2888 ◽

Cited By ~ 9

Author(s):

Negar Naderpoor ◽

Aya Mousa ◽

Luisa Fernanda Gomez Arango ◽

Helen L. Barrett ◽

Marloes Dekker Nitert ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin D ◽

Gut Microbiota ◽

Randomised Clinical Trial ◽

Vitamin D Supplementation ◽

Faecal Microbiota ◽

Lower Abundance ◽

Α Diversity ◽

Significant Difference

In animal studies, vitamin D supplementation has been shown to improve gut microbiota and intestinal inflammation. However, limited evidence exists on the effect of vitamin D supplementation on the human gut microbiota. We examined the effect of vitamin D supplementation on faecal microbiota in 26 vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) ≤50 nmol/L), overweight or obese (BMI ≥25 kg/m2) otherwise healthy adults. Our study was ancillary to a community based double-blind randomised clinical trial, conducted between 2014 and 2016. The participants provided stool samples at baseline and after 100,000 international units (IU) loading dose of cholecalciferol followed by 4000 IU daily or matching placebo for 16 weeks. Faecal microbiota was analysed using 16S rRNA sequencing; V6–8 region. There was no significant difference in microbiome α-diversity between vitamin D and placebo groups at baseline and follow-up (all p > 0.05). In addition, no clustering was found based on vitamin D supplementation at follow-up (p = 0.3). However, there was a significant association between community composition and vitamin D supplementation at the genus level (p = 0.04). The vitamin D group had a higher abundance of genus Lachnospira, and lower abundance of genus Blautia (linear discriminate analysis >3.0). Moreover, individuals with 25(OH)D >75 nmol/L had a higher abundance of genus Coprococcus and lower abundance of genus Ruminococcus compared to those with 25(OH)D <50 nmol/L. Our findings suggest that vitamin D supplementation has some distinct effects on faecal microbiota. Future studies need to explore whether these effects would translate into improved clinical outcomes.

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Modifications of Gut Microbiota after Grape Pomace Supplementation in Subjects at Cardiometabolic Risk: A Randomized Cross-Over Controlled Clinical Trial

Foods ◽

10.3390/foods9091279 ◽

2020 ◽

Vol 9 (9) ◽

pp. 1279

Author(s):

Sara Ramos-Romero ◽

Daniel Martínez-Maqueda ◽

Mercè Hereu ◽

Susana Amézqueta ◽

Josep Lluís Torres ◽

...

Keyword(s):

Clinical Trial ◽

Gut Microbiota ◽

Cardiometabolic Risk ◽

Short Chain Fatty Acids ◽

Grape Pomace ◽

Controlled Clinical Trial ◽

Insulin Levels ◽

Equivalent Control ◽

Cardiometabolic Markers ◽

Dietary Bioactive Compounds

Polyphenols are dietary bioactive compounds able to induce modifications in the gut microbiota profile, although more clinical studies are needed. With this aim, a randomized cross-over clinical trial was conducted, where 49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors) were supplemented with a daily dose of 8 g of grape pomace (GP) for 6 weeks, with an equivalent control (CTL) period. The levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales, Bacteroides and Prevotella were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs) were assessed by gas chromatography. Several cardiometabolic markers were evaluated in blood samples. GP reduced insulin levels only in half of the participants (responders). GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency (p = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of Bacteroides in non-responder subjects. The reduction of insulin levels in subjects at cardiometabolic risk upon GP supplementation appears not to be induced by changes in the major subgroups of gut microbiota. Further studies at the species level may help to elucidate the possible role of microbiota in GP-induced insulinemic status.

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Effect of Probiotic Supplementation along with Calorie Restriction on Metabolic Endotoxemia, Trimethylamine-N-Oxide, Inflammation, Metabolic Factors, and Gut Microbiota Profile in Coronary Artery Disease Patients: A Double Blind Placebo Controlled Randomized Clinical Trial

10.21203/rs.3.rs-17854/v2 ◽

2020 ◽

Author(s):

Jalal Moludi ◽

Hossein Samadi Kafil ◽

Pouria Gholizadeh ◽

Mohammad Alizadeh

Keyword(s):

Coronary Artery Disease ◽

Clinical Trial ◽

Coronary Artery ◽

Gut Microbiota ◽

Metabolic Factors ◽

Probiotic Supplementation ◽

Double Blind ◽

Double Blind Placebo ◽

Artery Disease ◽

Metabolic Endotoxemia

Abstract The authors have requested that this preprint be withdrawn due to author disagreement.

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Design of the GutHeart-targeting gut microbiota to treat heart failure-trial: a Phase II, randomized clinical trial

ESC Heart Failure ◽

10.1002/ehf2.12332 ◽

2018 ◽

Vol 5 (5) ◽

pp. 977-984 ◽

Cited By ~ 19

Author(s):

Cristiane C.K. Mayerhofer ◽

Ayodeji O. Awoyemi ◽

Samuel D. Moscavitch ◽

Knut Tore Lappegård ◽

Johannes R. Hov ◽

...

Keyword(s):

Heart Failure ◽

Clinical Trial ◽

Gut Microbiota ◽

Randomized Clinical Trial ◽

Phase Ii ◽

Heart Failure Trial ◽

Treat Heart Failure

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Microbial Interventions to Control And Reduce Blood Pressure In Australia (Microbia): Rationale And Design of A Double-Blinded Randomised Cross-Over Placebo Controlled Trial

10.21203/rs.3.rs-149397/v1 ◽

2021 ◽

Author(s):

Dakota Rhys-Jones ◽

Rachel Climie ◽

Hamdi Jama ◽

Paul Gill ◽

Geoffrey Head ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Gut Microbiota ◽

Resistant Starch ◽

Corn Starch ◽

Controlled Trial ◽

Short Chain Fatty Acids ◽

Reduce Blood Pressure ◽

Clinical Trial Registry ◽

Double Blinded

Abstract Background: Hypertension is a prevalent chronic disease worldwide that remains poorly controlled. Recent studies support the concept that the gut microbiota is involved in the development of hypertension, and that dietary fibre intake may act through the gut microbiota to lower blood pressure (BP). Resistant starch is a type of prebiotic fibre which is metabolized by commensal bacteria in the colon to produce short-chain fatty acids (SCFA), including acetate, propionate, and butyrate. Previous work in pre-clinical models provide strong evidence that both prebiotic fibre as well as SCFAs (i.e. postbiotics) can prevent the development of hypertension. The aim of this clinical trial is to determine if acetylated and butyrylated modified resistant starch can decrease BP of hypertensive individuals via the modulation of the gut microbiota and release of high levels of SCFAs. Methods: This is a phase IIa double-blinded, randomised, cross-over, placebo controlled trial. Participants are randomly allocated to receive either a diet containing 40g/day of the modified resistant starch or placebo (corn starch or regular flour) for three weeks on each diet, with a three week washout period between the two diets. BP is measured in the office, at home, and using a 24 hour ambulatory device. Arterial stiffness is measured using carotid-to-femoral pulse wave velocity. Our primary endpoint is a reduction in ambulatory daytime systolic BP. Secondary endpoints include changes to circulating cytokines, immune markers, and modulation to the gut microbiome. Discussion: The findings of this study will provide the first evidence for the use of a combination of pre- and postbiotics to lower BP in humans. The results are expected at the end of 2021.Trial registration: Australia and New Zealand Clinical Trial Registry ACTRN12619000916145, registered on 1/07/2019.

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Metformin induces weight loss associated with gut microbiota alteration in non-diabetic obese women: a randomized double-blind clinical trial

Acta Endocrinologica ◽

10.1530/eje-18-0826 ◽

2019 ◽

Vol 180 (3) ◽

pp. 165-176 ◽

Cited By ~ 14

Author(s):

Hanieh-Sadat Ejtahed ◽

Raul Y Tito ◽

Seyed-Davar Siadat ◽

Shirin Hasani-Ranjbar ◽

Zahra Hoseini-Tavassol ◽

...

Keyword(s):

Clinical Trial ◽

Gut Microbiota ◽

Amplicon Sequencing ◽

Fecal Microbiota ◽

Pharmacological Therapy ◽

Microbiota Composition ◽

Obese Women ◽

Double Blind ◽

Baseline Values ◽

Gut Microbiota Composition

Objective The increasing prevalence of obesity over the past few decades constitutes a global health challenge. Pharmacological therapy is recommended to accompany life-style modification for obesity management. Here, we perform a clinical trial to investigate the effects of metformin on anthropometric indices and gut microbiota composition in non-diabetic, treatment-naive obese women with a low-calorie diet (LCD). Design Randomized double-blind parallel-group clinical trial Methods Forty-six obese women were randomly assigned to the metformin (500 mg/tab) or placebo groups using computer-generated random numbers. Subjects in both groups took two tablets per day for 2 months. Anthropometric measurements and collection of blood and fecal samples were done at the baseline and at the end of the trial. Gut microbiota composition was assessed using 16S rRNA amplicon sequencing. Results Twenty-four and twenty-two subjects were included in the metformin + LCD and placebo + LCD groups, respectively; at the end of trial, 20 and 16 subjects were analyzed. The metformin + LCD and placebo + LCD caused a 4.5 and 2.6% decrease in BMI from the baseline values, respectively (P < 0.01). Insulin concentration decreased in the metformin + LCD group (P = 0.046). The overall fecal microbiota composition and diversity were unaffected in the metformin + LCD group. However, a significant specific increase in Escherichia/Shigella abundance was observed after metformin + LCD intervention (P = 0.026). Fecal acetate concentration, but not producers, was significantly higher in the placebo + LCD group, adjusted for baseline values and BMI (P = 0.002). Conclusions Despite the weight reduction after metformin intake, the overall fecal microbiota composition remained largely unchanged in obese women, with exception of changes in specific proteobacterial groups.

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