Design and reporting of prebiotic and probiotic clinical trials in the context of diet and the gut microbiome.

Diet is a major determinant of the gastrointestinal microbiome composition and function, yet our understanding of how it impacts the efficacy of prebiotics and probiotics is limited. Here we examine current evidence of dietary influence on prebiotic and probiotic efficacy in human studies, including potential mechanisms. We propose that habitual diet be included as a variable in prebiotic and probiotic intervention studies.

The effects of chicory inulin-type fructans supplementation on weight management outcomes: systematic review, meta-analysis, and meta-regression of randomized controlled trials.

Background: Excess body weight and adiposity can adversely affect metabolic health. Prebiotics such as inulin-type fructans (ITFs) from chicory root are known to modulate gut microbiota and may improve body weight regulation.

Objectives: This study aimed to assess evidence for chicory ITF supplementation to support weight management.

Isomaltulose Enhances GLP-1 and PYY Secretion to a Mixed Meal in People With or Without Type 2 Diabetes as Compared to Saccharose.

Scope: Secretion of the gut hormones glucagon-like peptide (GLP-1) and peptide YY (PYY) are induced by nutrients reaching the lower small intestine which regulate insulin and glucagon release, inhibit appetite, and may improve β-cell regeneration. The aim is to test the effect of a slowly digested isomaltulose (ISO) compared to the rapidly digested saccharose (SAC) as a snack given 1 h before a standardized mixed meal test (MMT) on GLP-1, PYY, glucose-dependent insulinotropic peptide (GIP), and metabolic responses in participants with or without type 2 diabetes (T2DM).

Methods And Results: Fifteen healthy volunteers and 15 patients with T2DM consumed either 50 g ISO or SAC 1 h preload of MMT on nonconsecutive days.

Inulin-type fructans and 2'fucosyllactose alter both microbial composition and appear to alleviate stress-induced mood state in a working population compared to placebo (maltodextrin): the EFFICAD Trial, a randomized, controlled trial.

Background: There is increasing interest in the bidirectional relationship existing between the gut and brain and the effects of both oligofructose and 2'fucosyllactose to alter microbial composition and mood state. Yet, much remains unknown about the ability of oligofructose and 2'fucosyllactose to improve mood state via targeted manipulation of the gut microbiota.

Objectives: We aimed to compare the effects of oligofructose and 2'fucosyllactose alone and in combination against maltodextrin (comparator) on microbial composition and mood state in a working population.

Brush border enzyme hydrolysis and glycaemic effects of isomaltulose compared to other saccharides in dogs.

Digestible carbohydrates differ in glycaemic response, therewith having the potential to influence metabolic conditions such as insulin resistance and diabetes mellitus. Isomaltulose has been proven to lower the glycaemic response in humans, which to date has not been studied in dogs. Therefore, the aim of the present study was to characterise the digestibility, as well as the physiological effects of isomaltulose in dogs, in comparison to other saccharides.

Oligofructose, 2'fucosyllactose and β-glucan in combination induce specific changes in microbial composition and short-chain fatty acid production compared to sole supplementation.

Aims: In this study, we explored the effects that the prebiotic inulin-type fructans, and prebiotic candidates: 2'fucosyllactose and β-glucan from barley, singular and in combination had on microbial load, microbiome profile, and short-chain fatty acid production. This was carried out as a prescreening tool to determine combinations that could be taken forward for use in a human intervention trial.

Methods And Results: Effects of inulin-type fructans, 2'fucosyllactose and β-glucan from barley in singular and combination on microbial load and profile and short-chain fatty acid production (SCFA) was conducted using in vitro batch culture fermentation over 48 h.

Effect of chicory-derived inulin-type fructans on abundance of and on bowel function: a systematic review with meta-analyses.

Inulin-type fructans are considered to stimulate the growth of beneficial microorganisms, like in the gut and support health. However, both the fructan source and chemical structure may modify these effects. A systematic review was conducted to assess the effects of chicory-derived inulin-type fructans consumed either in specific foods or as dietary supplements on abundance of in the gut and on health-related outcomes.

Palatinose (Isomaltulose) and Prebiotic Inulin-Type Fructans Have Beneficial Effects on Glycemic Response and Gut Microbiota Composition in Healthy Volunteers-A Real-Life, Retrospective Study of a Cohort That Participated in a Digital Nutrition Program.

It is well-appreciated that the diet is a crucial tool to counteract cardiometabolic disturbances due to its impact on blood glucose concentration and gut microbiome. This retrospective analysis aimed to examine whether the inclusion of isomaltulose and prebiotic inulin-type fructans (ITF) into the habitual diet has an impact on glycemic control and gut microbiota. Furthermore, we examined interindividual differences in glycemic response to sugar replacement with isomaltulose.

Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial.

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of OraftiSynergy1 or an unsupplemented control formula until the age of 12 months.

Reply to "Comparisons of Within-Group Instead of Between-Group Affect the Conclusions. Comment on: Changes in Weight and Substrate Oxidation in Overweight Adults Following Isomaltulose Intake during a 12-Week Weight Loss Intervention: A Randomized, Double-Blind, Controlled Trial. 2019, (10), 2367".

We thank the authors Vorland, Kyle and Brown for their interest in our paper and their comments [...

Potential Markers of Dietary Glycemic Exposures for Sustained Dietary Interventions in Populations without Diabetes.

There is considerable interest in dietary and other approaches to maintaining blood glucose concentrations within the normal range and minimizing exposure to postprandial hyperglycemic excursions. The accepted marker to evaluate the sustained maintenance of normal blood glucose concentrations is glycated hemoglobin A1c (HbA1c). However, although this is used in clinical practice to monitor glycemic control in patients with diabetes, it has a number of drawbacks as a marker of efficacy of dietary interventions that might beneficially affect glycemic control in people without diabetes.

Prebiotics Inhibit Proteolysis by Gut Bacteria in a Host Diet-Dependent Manner: a Three-Stage Continuous Gut Model Experiment.

Dietary protein residue can result in microbial generation of various toxic metabolites in the gut, such as ammonia. A prebiotic is "a substrate that is selectively utilised by host microorganisms conferring a health benefit" (G. R.

Efficacy of Isomaltulose Compared to Sucrose in Modulating Endothelial Function in Overweight Adults.

Hyperglycemia is linked to impaired arterial endothelial function (EF), an early sign of cardiovascular disease. We compared the efficacy of low-glycemic index isomaltulose (Palatinose™) with that of sucrose in modulating EF, as assessed by flow-mediated dilation (FMD). In this double-blinded cross-over study, 80 overweight mildly hypertensive subjects were randomized to receive 50 g of either isomaltulose or sucrose.

Changes in Weight and Substrate Oxidation in Overweight Adults Following Isomaltulose Intake During a 12-Week Weight Loss Intervention: A Randomized, Double-Blind, Controlled Trial.

Low-glycemic compared to high-glycemic diets have been shown to improve metabolic status and enhance fat oxidation. The randomized, double-blind, controlled intervention study aimed to evaluate the effects of an energy-reduced diet containing isomaltulose (ISO, Palatinose™) versus sucrose (SUC) on body weight loss. Sixty-four healthy overweight/obese adults were allocated to consume either 40g/d ISO or SUC added to an energy-reduced diet for 12 weeks.

Prebiotic Supplementation of Fecal Fermentations Inhibits Proteolysis by Gut Bacteria, and Host Diet Shapes Gut Bacterial Metabolism and Response to Intervention.

Metabolism of protein by gut bacteria is potentially detrimental due to the production of toxic metabolites, such as ammonia, amines, -cresol, and indole. The consumption of prebiotic carbohydrates results in specific changes in the composition and/or activity of the microbiota that may confer benefits to host well-being and health. Here, we have studied the impact of prebiotics on proteolysis within the gut Anaerobic stirred batch cultures were inoculated with feces from omnivores ( = 3) and vegetarians ( = 3) and four protein sources (casein, meat, mycoprotein, and soy protein) with and without supplementation by an oligofructose-enriched inulin.

Effects of prebiotic inulin-type fructans on blood metabolite and hormone concentrations and faecal microbiota and metabolites in overweight dogs.

Because obesity is associated with many co-morbidities, including diabetes mellitus, this study evaluated the second-meal effect of a commercial prebiotic, inulin-type fructans, and the effects of the prebiotic on faecal microbiota, metabolites and bile acids (BA). Nine overweight beagles were used in a replicated 3×3 Latin square design to test a non-prebiotic control (cellulose) against a low (equivalent to 0·5 % diet) and high dose (equivalent to 1·0 % diet) of prebiotic over 14-d treatments. All dogs were fed the same diet twice daily, with treatments provided orally via gelatin capsules before meals.

Inulin-Type Fructan Supplementation of 3- to 6-Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention.

Background: Inulin-type fructans used in formula have been shown to promote microbiota composition and stool consistency closer to those of breastfed infants and to have beneficial effects on fever occurrence, diarrhea, and incidence of infections requiring antibiotic treatment in infants.

Objectives: The primary study aim was to explore whether prophylactic supplementation with prebiotic fructans is able to influence the frequency of infectious diseases in kindergarten children during a winter period. A secondary objective was to ascertain the effect on the intestinal microbiota.

Oligofructose Provides Laxation for Irregularity Associated with Low Fiber Intake.

Inadequate dietary fiber intake contributes to the prevalent irregularity and constipation in Western countries. Although eating adequate amounts of fibers from fiber-rich foods, foods with added fibers and dietary fiber supplements is considered the first option for improving laxation, the efficacy can vary among types of fibers. The present study is a randomized control trial that included healthy adult participants with ≤3 bowel movements/week and a habitual low dietary fiber intake in a parallel design to evaluate the benefits for laxation by supplementing the daily diet with oligofructose (Orafti P95; OF), a fermentable source of fiber and established prebiotic ( = 49); maltodextrin was the placebo ( = 48).

Correction to: A comparison of isomaltulose versus maltodextrin ingestion during soccer-specific exercise.

The article "A comparison of isomaltulose versus maltodextrin ingestion during soccer-specific exercise", written by "Emma J. Stevenson, Anthony Watson, Stephan Theis, Anja Holz,·Liam D. Harper, Mark Russell", was originally published Online First without open access.

A comparison of isomaltulose versus maltodextrin ingestion during soccer-specific exercise.

Purpose: The performance and physiological effects of isomaltulose and maltodextrin consumed intermittently during prolonged soccer-specific exercise were investigated.

Methods: University soccer players (n = 22) performed 120 min of intermittent exercise while consuming 8% carbohydrate-electrolyte drinks (equivalent to ~ 20 g h) containing maltodextrin (Glycaemic Index: 90-100), isomaltulose (Glycaemic Index: 32) or a carbohydrate-energy-free placebo in a manner replicating the practices of soccer players (i.e.

Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials.

Low glycemic index diets are supposed to achieve a more beneficial effect on blood glucose control in people with diabetes mellitus and may also provide metabolic benefits for the general population. A prototype of a low-glycemic index carbohydrate is the natural occurring disaccharide isomaltulose that can be commercially produced from sucrose (beet sugar) to industrial scale. It is currently used in various food and drink applications as well as special and clinical nutrition feeds and formula diet as a food ingredient and alternative sugar.

Replacement of glycaemic carbohydrates by inulin-type fructans from chicory (oligofructose, inulin) reduces the postprandial blood glucose and insulin response to foods: report of two double-blind, randomized, controlled trials.

Purpose: Inulin-type fructans are recognized as prebiotic dietary fibres and classified as non-digestible carbohydrates that do not contribute to glycaemia. The aim of the present studies was to investigate the glycaemic response (GR) and insulinaemic response (IR) to foods in which sucrose was partially replaced by inulin or oligofructose from chicory.

Methods: In a double-blind, randomized, controlled cross-over design, 40-42 healthy adults consumed a yogurt drink containing oligofructose or fruit jelly containing inulin and the respective full-sugar variants.

Prebiotic inulin-type fructans induce specific changes in the human gut microbiota.

Objective: Contrary to the long-standing prerequisite of inducing selective (ie, bifidogenic) effects, recent findings suggest that prebiotic interventions lead to ecosystem-wide microbiota shifts. Yet, a comprehensive characterisation of this process is still lacking. Here, we apply 16S rDNA microbiota profiling and matching (gas chromatography mass spectrometry) metabolomics to assess the consequences of inulin fermentation both on the composition of the colon bacterial ecosystem and faecal metabolites profiles.

The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study.

Background: Constipation is a common disorder in children.

Objective: The objective of this study is to assess the beneficial effects of a daily supplementation with Orafti inulin-type fructans in 2-5 year old constipated children.

Methods: Double-blind, randomised, placebo-controlled parallel group trial where constipated children received two doses of 2 g Orafti inulin-type fructans (OF:IN) or placebo (maltodextrin) for 6 weeks.