scholarly journals Corrigendum: Rosli D, Shahar S, Manaf ZA, Lau HJ, Yusof NYM, Haron MR, Majid HA. Randomized controlled trial on the effect of partially hydrolyzed guar gum supplementation on diarrhea frequency and gut microbiome count among pelvic radiation patients. JPEN J Parenter Enteral Nutr . 2021;45(2):277‐286

2021 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiome ◽  
Guar Gum ◽  
Controlled Trial ◽  
Pelvic Radiation ◽  
Randomized Controlled ◽  
Partially Hydrolyzed Guar Gum

scholarly journals Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

scholarly journals Gut Microbiota Is Linked to Physical Health Improvements Resulting from Energy-Restricted Diet and Exercise: A Randomized Controlled Trial in Healthy Adults

Proceedings ◽  
2020 ◽  
Vol 61 (1) ◽  
pp. 8
Author(s):  
Shakuntla Gondalia ◽  
Matthew Cooke ◽  
Stephen Keenan ◽  
Regina Belski
Keyword(s):  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Gut Microbiota ◽  
Physical Health ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Energy Restriction ◽  
Restricted Diet ◽  
Randomized Controlled ◽  
Continuous Energy

Animal studies have demonstrated that energy-restricted diets and exercise affect the gut microbiome and are positively linked to physical health; however, less is known about the impacts of various patterns of dietary restriction combined with exercise on the gut microbiota and associated health outcomes in humans. This study aimed to determine if an energy-restricted diet combined with resistance training altered the gut microbiome, and whether any changes were associated with differences in body composition, dietary intake, or biomarkers of metabolic health. Twenty-six healthy males and females, aged 19–36 years with BMIs of 22–35 kg/m2, were enrolled in a 2-arm parallel, randomized controlled trial and followed either a 5:2 intermittent fasting (IFT, n = 13) or continuous energy restriction (CERT, n = 13) diet combined with supervised resistance training for 12 weeks. Both treatments resulted in decreased body weight and increased lean body mass. Shifts in the abundance of, Faecalibacterium prausnitzii, a high butyrate producer, was positively associated with changes in lean body mass (IFTp = 0.05, CERTp = 0.01) in both the groups. Moreover, in the CERT group, changes in Coprococcus genus were negatively associated with energy (p = 0.009) and fat intake (p= 0.03) and positively associated with body fat (p = 0.02). Overall, the findings indicate that using resistance training paired with either intermittent or continuous energy restriction, result in similar changes in bacterial diversity and shifts in relative abundance of bacterial taxa. The shift in specific bacterial taxa were positively associated with measures of physical health providing further support to the proposed relationship between energy consumption, exercise, gut microbiota, and physical health.

scholarly journals A Walnut-Enriched Diet Affects Gut Microbiome in Healthy Caucasian Subjects: A Randomized, Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (2) ◽  
pp. 244 ◽  
Author(s):  
Charlotte Bamberger ◽  
Andreas Rossmeier ◽  
Katharina Lechner ◽  
Liya Wu ◽  
Elisa Waldmann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Randomized Controlled

Impact of a Vancomycin-Induced Shift of the Gut Microbiome in a Gram-Negative Direction on Plasma Factor VIII:C Levels: Results from a Randomized Controlled Trial

2021 ◽  
Author(s):  
Gro Grimnes ◽  
Soerajja Bhoelan ◽  
Kristian Hindberg ◽  
Mark Davids ◽  
Max Nieuwdorp ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Systemic Inflammation ◽  
Complement Activation ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Gram Negative Bacteria ◽  
Gram Negative ◽  
Negative Direction ◽  
Randomized Controlled ◽  
Plasma Factor

Abstract Rationale Inflammation is present in several conditions associated with risk of venous thromboembolism. The gut microbiome might be a source of systemic inflammation and activation of coagulation, by translocation of lipopolysaccharides from gram-negative bacteria to the systemic circulation. Objective To investigate whether a vancomycin-induced shift of the gut microbiome in a gram-negative direction influences systemic inflammation and plasma factor (F) VIII procoagulant activity (FVIII:C). Methods and Results We performed a randomized controlled trial including 43 healthy volunteers aged 19 to 37 years. Twenty-one were randomized to 7 days of oral vancomycin intake and 22 served as controls. Feces and blood were sampled at baseline, the day after the end of intervention, and 3 weeks after intervention. Gut microbiome composition was assessed by amplicon sequencing. FVIII:C was measured using an activated partial thromboplastin time-based assay, cytokines were measured using multiplex technology, complement activation was measured using the enzyme-linked immunosorbent assay, and high-sensitivity C-reactive protein (CRP) was measured by an immunoturbidimetric assay. Vancomycin intake reduced gut microbiome diversity and increased the abundance of gram-negative bacteria. Change in FVIII:C in the intervention group was +4 IU/dL versus −6 IU/dL (p = 0.01) in the control group. A similar change was observed for log-transformed CRP (+0.21 mg/dL vs. −0.25 mg/dL, p = 0.04). The cytokines and complement activation markers remained similar in the two groups. Conclusion The found slight increases in FVIII:C and CRP levels might support the hypothesis that a vancomycin-induced gram-negative shift in the gut microbiome could induce increased systemic inflammation and thereby a procoagulant state.

The Impact of Enriched Resistant Starch Type‐2 Cookies on the Gut Microbiome in Hemodialysis Patients: A Randomized Controlled Trial

2021 ◽  
pp. 2100374
Author(s):  
Julie Ann Kemp ◽  
Bruna Regis Paiva ◽  
Henrique Fragoso dos Santos ◽  
Hugo Emiliano Jesus ◽  
Hannah Craven ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiome ◽  
Resistant Starch ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Randomized Controlled ◽  
The Impact

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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