Modelling the public health benefits of fibre fortification in the Chinese population through food reformulation.

OBJECTIVES: Various studies have highlighted how consuming adequate dietary fibre (DF) foods could confer multiple potential health benefits to humans, though data suggested that the average intake of the population is below the recommendations. The aim of this study, which involved probabilistic, mathematical and statistical modelling, was to understand, for the first time, how fibre fortification in a broad array of food categories could impact the diet and health status of Chinese consumers. DESIGN: A simulation-based approach was used to examine the potential impact of fibre fortification. The China Health and Nutrition Survey dataset was used to evaluate intakes of DF together with a dietary intake mathematical model. Commercially manufactured foods and beverages eligible for fibre fortification were identified and a total of 296 food and beverages were selected for fibre fortification calculation. Foods and beverages eligible for fibre fortification and the concentration of fibre used at intervention were identified based on Chinese legislations and regulations of nutrition label claims. Populations who meet the dietary reference values of fibre fortification have their health outcomes such as weight, cardiovascular disease (CVD) and type 2 diabetes risk quantified prefibre and postfibre reformulation as per published studies. RESULTS: The simulated fibre fortification intervention model has shown that the mean DF intake increased by 13.28%, from 12.8 g/day of baseline to 14.5 g/day, leading to an increase of 48% (from 6.85% to 10.13%) and 54% (from 14.22% to 21.84%) of the adult and children population, respectively, achieving the recommended fibre guidelines. Additionally, 234 diabetes cases per day (85 340 cases per year) as well as 73 065 deaths secondary to CVD could also potentially be averted or delayed with the increase of DF intake via fibre fortification. CONCLUSIONS: This study provides a practical application implicating the potential public health benefits that could be achieved with food product reformulation.

Gastrointestinal tolerance of D-allulose in children: an acute, randomised, double-blind, placebo-controlled, cross-over study.

D-Allulose, a low-calorie sugar, provides an attractive alternative to added sugars in food and beverage products. There is however limited data on its gastrointestinal (GI) tolerance, with only two studies in adults, and no studies in children to date. We therefore performed an acute, randomised, double-blind, placebo-controlled, cross over study designed to determine, for the first time, the GI tolerance of 2 doses of D-allulose (2.5 g per 120 ml and 4.3 g per 120 ml) in young children. The primary tolerance endpoint was the difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake. Secondary endpoints included the assessment of stool frequency, stool consistency, and the presence of GI symptoms. Only one participant in the low dose group experienced a stool type 6 or 7, while no participants experienced a stool type 6 or 7 in the high dose group. A statistically significant difference in the change in stool frequency compared to placebo in the high dose group (p = 0.044) was found, with no significant difference between the groups for stool consistency and no participants experienced unusual stool frequency. All the encountered adverse events were non-serious, either mild or moderate, and there were no serious adverse events. All in all, D-allulose was tolerated well in children, making this ingredient a good candidate to reformulate commercially produced goods by replacing added sugars with lower caloric content.

Low-no-calorie sweeteners exert marked compound-specific impact on the human gut microbiota ex vivo.

Low-no-calorie sweeteners (LNCS) are used as sugar substitutes as part of strategies to reduce the risk of chronic diseases related to high sugar intake (e.g. type 2 diabetes (T2D)). This study investigated how a range of sweeteners [tagatose (TA)/maltitol (MA)/sorbitol (SO)/stevia (ST)/sucralose (SU)/acesulfame K (ACK)] impact the gut microbiota of T2D subjects and healthy human adults using the ex vivo SIFR® technology (n = 12). The cohort covered clinically relevant interpersonal and T2D-related differences. ACK/SU remained intact while not impacting microbial composition and metabolite production. In contrast, TA/SO and ST/MA were respectively readily and gradually fermented. ST and particularly TA/SO/MA increased bacterial density and SCFA production product-specifically: SO increased acetate (∼Bifidobacterium adolescentis), whilst MA/ST increased propionate (∼Parabacteroides distasonis). TA exerted low specificity as it increased butyrate for healthy subjects, yet propionate for T2D subjects. Overall, LNCS exerted highly compound-specific effects stressing that results obtained for one LNCS cannot be generalised to other LNCS.

Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world.

Traditional animal models are increasingly being replaced by new approach methodologies (NAMs) which focus on predicting toxicity of chemicals based on mechanistic data rather than apical endpoint data usually obtained from animal models. Beyond in vitro genetic tests, however, only a handful of NAMs have been successfully implemented in regulatory decision-making processes, mostly in the cosmetics and chemicals sector. Regulatory guidance on food safety testing in many jurisdictions still relies on data obtained from animal studies. This is due to the lack of validated models to predict systemic toxicity, which is essential to develop health-based guidance values for food additives. Other factors limiting the adoption of NAMs into food safety assessment include sector legislation lagging behind scientific progress, and lack of training and expertise to use the new models. While regulatory and industry bodies are working to combat these challenges, more needs to be done before these models can be used as standalone tools for regulatory decision-making. This review summarizes the current state and challenges of regulatory acceptance of NAMs for decision-making, and the efforts by governing bodies and industry to transition from animal testing for food safety assessments.

Alternatives to animal testing in toxicity testing: Current status and future perspectives in food safety assessments.

The development of alternative methods to animal testing has gained great momentum since Russel and Burch introduced the "3Rs" concept of Reduction, Refinement, and Replacement of animals in safety testing in 1959. Several alternatives to animal testing have since been introduced, including but not limited to in vitro and in chemico test systems, in silico models, and computational models (e.g., [quantitative] structural activity relationship models, high-throughput screens, organ-on-chip models, and genomics or bioinformatics) to predict chemical toxicity. Furthermore, several agencies have developed robust integrated testing strategies to determine chemical toxicity. The cosmetics sector is pioneering the adoption of alternative methodologies for safety evaluations, and other sectors are aiming to completely abandon animal testing by 2035. However, beyond the use of in vitro genetic testing, agencies regulating the food industry have been slow to implement alternative methodologies into safety evaluations compared with other sectors; setting health-based guidance values for food ingredients requires data from systemic toxicity, and to date, no standalone validated alternative models to assess systemic toxicity exist. The abovementioned models show promise for assessing systemic toxicity with further research. In this paper, we review the current alternatives and their applicability and limitations in food safety evaluations.

Age-Dependent Prebiotic Effects of Soluble Corn Fiber in M-SHIME® Gut Microbial Ecosystems.

Soluble corn fiber (SCF) has demonstrated prebiotic effects in clinical studies. Using an in vitro mucosal simulator of the human intestinal microbial ecosystem (M-SHIME®) model, the effects of SCF treatment on colonic microbiota composition and metabolic activity and on host-microbiome interactions were evaluated using fecal samples from healthy donors of different ages (baby [≤ 2 years], n = 4; adult [18-45 years], n = 2; elderly [70 years], n = 1). During the 3-week treatment period, M-SHIME® systems were supplemented with SCF daily (baby, 1.5, 3, or 4.5 g/d; adult, 3 or 8.5 g/d; and elderly, 8.5 g/d). M-SHIME® supernatants were evaluated for their effect on the intestinal epithelial cell barrier and inflammatory responses in lipopolysaccharide. (LPS)-stimulated cells. Additionally, short-chain fatty acid (SCFA) production and microbial community composition were assessed. In the baby and adult models, M-SHIME® supernatants from SCF treated vessels protected Caco-2 membrane integrity from LPS-induced damage. SCF treatment resulted in the expansion of Bacteroidetes, Firmicutes, and Bifidobacterial, as well as increased SCFA production in all age groups. SCF tended to have the greatest effect on propionate production. These findings demonstrate the prebiotic potential of SCF in babies, adults, and the elderly and provide insight into the mechanisms behind the observed prebiotic effects.

Moderate intakes of soluble corn fibre or inulin do not cause gastrointestinal discomfort and are well tolerated in healthy children.

We investigated the gastrointestinal (GI) tolerance of soluble corn fibre (SCF) compared with inulin in children 3-9 years old. SCF (3-8 g/d for 10d) was tolerated as well as inulin: no differences were identified in stool frequency and consistency, proportion of subjects with at least one loose stool or reporting symptoms during bowel movement. Compared to inulin, 6 g/d of SCF lowered gas severity in children aged 3-5 years old. No differences were noted for alpha and beta diversity, relative abundance of Bacteroidota, Firmicutes, Ruminococcaceae, or the Firmicutes to Bacteroidota ratio. Relative abundance of some specific strains (i.e. Anaerostipes, Bifidobacterium, Fusicatenibacter, Parabacteroides) varied depending on the fibre type and dose level. Fortification at a level of 6-8 g/d of SCF and/or inulin could help addressing the fibre gap without any GI discomfort.

Estimating the potential public health impact of fibre enrichment: a UK modelling study.

For improving human health, reformulation can be a tool as it allows individuals to consume products of choice while reducing intake of less desirable nutrients, such as sugars and fats, and potentially increasing intake of beneficial nutrients such as fibre. The potential effects of reformulating foods with increased fibre on diet and health need to be better understood. The objective of this statistical modelling study was to understand how fibre enrichment can affect the diet and health of consumers. The UK National Diet and Nutrition Survey datasets from 2014 to 2015 and 2015 to 2016 were utilised to evaluate intakes of fibre and kilocalories with a dietary intake model. Foods and beverages eligible for fibre enrichment were identified (n 915) based on EU legislation for fibre content claims. Those people who meet dietary reference values and fibre enrichment health outcomes such as weight, CVD and type 2 diabetes risk reductions were quantified pre- and post-fibre reformulation via Reynolds et al., D'Agostino et al. and QDiabetes algorithms, respectively. The fibre enrichment intervention showed a mean fibre intake of 19·9 g/d in the UK, signifying a 2·2 g/d increase from baseline. Modelling suggested that 5·9 % of subjects could achieve a weight reduction, 72·2 % a reduction in cardiovascular risk and 71·7 % a reduced risk of type 2 diabetes with fibre fortification (all Ps ≤ 0·05). This study gives a good overview of the potential public health benefits of reformulating food products using a straightforward enrichment scenario.

A Randomized, Double-Blind, Crossover Study to Determine the Available Energy from Soluble Fiber.

OBJECTIVE: Determining the available energy (caloric value) of dietary non-digestible fibers that are fermented to varying degrees by intestinal microbes and metabolized to short chain fatty acids is important for provision of accurate information to food and beverage manufacturers for reformulation and labeling purposes. The objective of this human study was to determine the available energy of soluble fiber products by measuring post consumption breath hydrogen, with inulin as a control. METHODS: PROMITOR® Soluble Corn Fiber 70 (SCF70) and PROMITOR® Soluble Corn Fiber 85B (SCF85B) are Tate & Lyle dietary fiber products with 70% and 85% fiber, respectively. The fiber portion of these products is structurally representative of the fiber portion of all PROMITOR® SCF products. The study conducted was a randomized, double-blind, crossover design. Breath hydrogen was quantified following consumption of beverages consisting of 8 oz. of water and: inulin (control), SCF70, or SCF85B at 5, 10, or 15 g (total ingredient weight, "as is"). Subjects were generally healthy men and women (N = 19), age 18 to 34 years, with body mass index (BMI) 19.3 to 24.8 kg/m2. The primary outcome was incremental area under the curve over 10 h (iAUC0-10 h) for inulin, SCF70, and SCF85B at each dose. The available energy (kcal/g ingredient and kcal/g fiber) from SCF70 and SCF85B at each dose was then calculated using inulin as the reference. RESULTS: Results demonstrated that breath hydrogen production was significantly lower following consumption of SCF70 and SCF85B compared to inulin at all consumption amounts. There were no significant differences in breath hydrogen production following consumption of SCF70 compared to SCF85B. CONCLUSION: The available energy per gram of fiber was not significantly different between the SCF70 and SCF85B PROMITOR® products. The available energy of the fiber portion of PROMITOR® SCF products was determined to be 0.2 kcal/gram.

Comparison of the effects of soluble corn fiber and fructooligosaccharides on metabolism, inflammation, and gut microbiome of high-fat diet-fed mice.

Dietary fibers are essential components of a balanced diet and have beneficial effects on metabolic functions. To gain insight into their impact on host physiology and gut microbiota, we performed a direct comparison of two specific prebiotic fibers in mice. During an 8-wk follow up, mice fed a high-fat diet (HFD) were compared with mice on a normal diet (basal condition, controls) and to mice fed the HFD but treated with one of the following prebiotics: fructooligosaccharides (FOS) or soluble corn fiber (SCF). Both prebiotic fibers led to a similar reduction of body weight and fat mass, lower inflammation and improved metabolic parameters. However, these health benefits were the result of different actions of the fibers, as SCF impacted energy excretion, whereas FOS did not. Interestingly, both fibers had very distinct gut microbial signatures with different short-chain fatty acid profiles, indicating that they do not favor the growth of the same bacterial communities. Although the prebiotic potential of different fibers may seem physiologically equivalent, our data show that the underlying mechanisms of action are different, and this by targeting different gut microbes. Altogether, our data provide evidence that beneficial health effects of specific dietary fibers must be documented to be considered a prebiotic and that studies devoted to understanding how structures relate to specific microbiota modulation and metabolic effects are warranted.

The Role of Soluble Corn Fiber on Glycemic and Insulin Response.

Increasing prevalence of type 2 diabetes mellitus (T2DM) in Asia has prompted the exploration of dietary fibers as an ingredient to attenuate glycemic response (GR). This study aims to compare the effects of replacing 50% of total carbohydrate with soluble corn fiber (SCF) or maltodextrin on the GR and insulin response (IR). In this randomized cross-over study, twenty-two healthy Chinese males aged between 21-60 years were recruited. The participants consumed glucose beverages and four test meals comprising SCF or maltodextrin in glutinous rice or as a drink. Repeated-measure ANOVA was used to compare the incremental area under the curve values of glucose (iAUGC) and insulin (iAUIC) of all the foods. Relative response (RR) of the beverages were also calculated and compared using paired t-test. SCF treatments had significantly lower iAUGC (p-value < 0.05) and iAUIC (p-value < 0.001) as compared to all treatments. Both treatments (rice and beverage) of maltodextrin were not significantly different from glucose (p-value > 0.05). Maltodextrin beverage had significantly increased postprandial GR and insulin secretion by 20% and 40%, respectively, when compared to SCF beverage (p-value < 0.001). This study shows that the inclusion of SCF into the diet is beneficial in controlling the postprandial GR. Replacing total carbohydrates with SCF effectively lowers GR and IR.

A review of the characteristics of dietary fibers relevant to appetite and energy intake outcomes in human intervention trials.

Background: Many intervention studies have tested the effect of dietary fibers (DFs) on appetite-related outcomes, with inconsistent results. However, DFs comprise a wide range of compounds with diverse properties, and the specific contribution of these to appetite control is not well characterized.Objective: The influence of specific DF characteristics [i.e., viscosity, gel-forming capacity, fermentability, or molecular weight (MW)] on appetite-related outcomes was assessed in healthy humans.Design: Controlled human intervention trials that tested the effects of well-characterized DFs on appetite ratings or energy intake were identified from a systematic search of literature. Studies were included only if they reported 1) DF name and origin and 2) data on viscosity, gelling properties, fermentability, or MW of the DF materials or DF-containing matrixes.Results: A high proportion of the potentially relevant literature was excluded because of lack of adequate DF characterization. In total, 49 articles that met these criteria were identified, which reported 90 comparisons of various DFs in foods, beverages, or supplements in acute or sustained-exposure trials. In 51 of the 90 comparisons, the DF-containing material of interest was efficacious for ≥1 appetite-related outcome. Reported differences in material viscosity, MW, or fermentability did not clearly correspond to differences in efficacy, whereas gel-forming DF sources were consistently efficacious (but with very few comparisons).Conclusions: The overall inconsistent relations of DF properties with respect to efficacy may reflect variation in measurement methodology, nature of the DF preparation and matrix, and study designs. Methods of DF characterization, incorporation, and study design are too inconsistent to allow generalized conclusions about the effects of DF properties on appetite and preclude the development of reliable, predictive, structure-function relations. Improved standards for characterization and reporting of DF sources and DF-containing materials are strongly recommended for future studies on the effects of DF on human physiology. This trial was registered at http://www.crd.york.ac.uk/PROSPERO as CRD42015015336.

Changing course in ageing research: The healthy ageing phenotype.

Ageing is often associated with the aged and the diseased, nevertheless ageing is a process that starts in-uterus and is characterised by a progressive functional loss but not necessarily by the presence of disease and poor quality of life. How to meander through life without crossing the confines of major chronic disease and cognitive and physical impairment remains one of the most relevant challenges for science and humankind. Delimiting that 'immaculate' trajectory - that we dub as the 'Healthy Ageing Phenotype' - and exploring solutions to help the population to stay or return to this trajectory should constitute the core focus of scientific research. Nevertheless, current efforts on ageing research are mainly focused on developing animal models to disentangle the human ageing process, and on age-related disorders often providing merely palliative solutions. Therefore, to identify alternative perspectives in ageing research, Unilever and the Medical Research Council (MRC) UK convened a Spark workshop entitled 'The Healthy Ageing Phenotype'. In this meeting, international specialists from complementary areas related to ageing research, gathered to find clear attributes and definitions of the 'Healthy Ageing Phenotype', to identify potential mechanisms and interventions to improve healthy life expectancy of the population; and to highlight areas within ageing research that should be prioritised in the future. General agreement was reached in recognising ageing research as a disaggregated field with little communication between basic, epidemiological and clinical areas of research and limited translation to society. A more holistic, multi-disciplinary approach emanating from a better understanding of healthy ageing trajectories and centred along human biological resilience, its maintenance and the reversibility from early deviations into pathological trajectories, is urgently required. Future research should concentrate on understanding the mechanisms that permit individuals to maintain optimal health when facing pathological hazards and on developing and assessing potential interventions that could aid to re-establish resilience when lost or guarantee its integrity if present. Furthermore it is fundamental that scientific findings are translated incessantly into clear messages delivered to governmental institutions, the industry and society in general.

Calcium supplementation and bone mineral accretion in adolescent girls: an 18-mo randomized controlled trial with 2-y follow-up.

BACKGROUND: A recent meta-analysis raised doubt as to whether calcium supplementation in children benefits spine and hip bone mineral density (BMD). OBJECTIVE: We used state-of-the-art measures of bone (fan-beam dual-energy X-ray absorptiometry and 4 bone turnover markers) to determine whether girls with low habitual calcium intake benefited from supplementation with a soluble form of calcium (calcium citrate malate dissolved in a fruit drink). DESIGN: The trial was an 18-mo randomized trial of calcium supplementation (792 mg/d) with follow-up 2 y after supplement withdrawal. Subjects were 96 girls (mean age: 12 y) with low calcium intakes (mean: 636 mg/d). The main outcome measure was change in total-body, lumbar spine, and total hip bone mineral content (BMC) during supplementation and 2 y after supplement withdrawal. Changes in BMD and bone turnover markers were secondary outcome measures. RESULTS: The mean additional calcium intake in the supplemented group was 555 mg/d. Compared with the control group, the supplemented group showed significantly (P < 0.05) greater gains in BMC (except at the total hip site) over the 18-mo study. BMD change was significantly (P < 0.05) greater for all skeletal sites, and concentrations of bone resorption markers and parathyroid hormone were significantly (P < 0.01) lower in the supplemented group than in the control group after 18 mo. After 42 mo, gains in BMC and BMD and differences in bone resorption were no longer evident. CONCLUSIONS: Calcium supplementation enhances bone mineral accrual in teenage girls, but the effect is short-lived. The likely mechanism for the effect of the calcium is suppression of bone turnover, which is reversed upon supplement withdrawal.