Medical foods in Alzheimer’s disease

Alzheimer’s disease(AD)is the most prevalent cause of dementia worldwide.Treatments achieving a marked improvement in symptoms or preventing or delaying the progression of the disease are not available.Various diet-related risk factors for AD have been identified.Evidence for a protective effect of the Mediterranean diet on AD risk is inconclusive.Medical foods are designed to meet specific dietary needs for certain diseases.Improvements in symptomatology and regional brain atrophy in AD have been claimed for several medical foods,for example,those providing ketone bodies as alternative energy supply to neurons,those containing precursors believed to improve synaptic function,and those addressing oxidative stress related to memory loss.Many methodological shortcomings render the interpretation of the available findings of medical food trials in AD difficult.Optimal results of medical foods in AD may be expected when administered in presymptomatic or early stages of the disease.This requires the reliable identification of minimal neuropathological changes related to AD.The outcome measures currently used may not be able to detect subtle changes in cognition and function in early AD.Large-scale clinical studies using valid,sensitive,and reliable assessment tools are needed to establish the efficacy of medical foods in AD.

Diet and medical foods in Parkinson’s disease

Parkinson’s disease (PD) is a slowly progressive neurodegenerative disorder with motor and non-motorsigns, which begins long before the diagnosis can be made. Pharmacotherapy with dopaminergic drugsis the mainstay of PD therapy. There is no currently available cure or disease-modifying treatment. Dietand various foods have been proposed as possible risk factors for PD. Nutritional supplementation withomega-3 fatty acids, vitamin D, B vitamins, and coenzyme Q may have potential in the management ofPD. In addition, several strategies could possibly lead to the development of medical foods in PD. Forexample, ketogenic diets may have effects complementary to pharmacotherapy. Gut microbial dysbiosisand altered microbial metabolites found in PD may lead to chronic low-grade inflammation in gut andbrain. Interventions targeting gut microbiota, such as the supplementation of probiotics, may providenovel approaches to PD in regard to both symptomatic treatment and disease modification. High qualityrandomized controlled trials need to be conducted in order to evaluate whether these food-basedstrategies have symptomatic efficacy or the potential to delay the progression of PD.

Using the Delphi method to propose foods for special medical purposes health effect evaluation indicators

Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health testing,as well as a big data platform for the health and safety evaluation of special medical foods.Methods:The Delphi method was used to conduct two rounds of expert consultation on the constructed FSMP health effect evaluation indicators.Results:Ten major items were identified after two rounds of expert consultation.Among these,there were 10 primary entries,32 secondary entries,50 tertiary entries,and 28 quaternary entries.Conclusion:The complete list of evaluation indicators contains 10 entries,which can comprehensively and systematically monitor adverse reactions to the use of FSMPs.The present findings lay the foundation for a big data platform to evaluate the health and safety of special foods.

A review on rules for examination of licensing criteria for producing foods for special medical purpose in China

In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.

Medical foods in USA at a glance

Increasing interest in attaining an optimal health have longstanding and are imperative for consumers,medical and health researchers and functional food scientists and producers among others.Functional food is defi ned as foods that have a biological function with a very broad range of coverage including natural and conventional foods with reported bioactivities,dietary supplements and medical foods.Its concept is inclusively broad and ambiguous.Medical food is a specifi c class of functional foods with clear defi nition and limited coverage to guarantee its integrity.This review introduced the defi nition of medical food by the US Food and Drug Administration,intended to clarify the differences among medical food,dietary supplements and conventional foods,and 1isted some examples of medical food products developed in the US.

New paradigm of oral rehydration in patients affected by irritable bowel syndrome with chronic diarrhea

Irritable bowel syndrome with diarrhea is a very frequent clinical condition characterized by disabling intestinal symptoms.This disease presents with daily abdominal pain for at least 3 months related to defecation and associated with a change in the frequency of bowel movements and the shape of the stool.International surveys about this disease report a global prevalence of about 1.5%.A new amino acid based electrolyte solution has recently been commercialized for oral rehydration in diarrhea.It is composed of water,electrolytes,and five selected amino acids that function as sodium co-transporters without containing glucose.In recent years,some studies explored the effectiveness of the amino acid based electrolyte beverage in oncologic patients with gastrointestinal mucositis,reporting good results.Recently,a prospective study to evaluate the clinical impact of the amino acid based medical beverage was conducted in patients with diarrhea predominant irritable bowel syndrome.The research was based on a real-life methodology minimizing the disruption of the routine care.One hundred patients suffering from irritable bowel syndrome with diarrhea drank a solution based on selected amino acids twice a day for 2 wk.Each enrolled patient completed the study and showed a significant response rate with regard to stool consistency and pain reduction.Based on this data,we can hypothesize that the amino acid based oral rehydration solution could be a valid tool in the treatment of patients affected by irritable bowel syndrome with diarrhea.It is certainly necessary to plan highquality clinical trials comparing glucose based oral solutions and amino acid based solutions in patients with persisting diarrhea.Probably in the near future all oral rehydration solutions will contain amino acids.

Mathematical rules for synergistic,additive,and antagonistic effects of multi-drug combinations and their application in research and development of combinatorial drugs and special medical food combinations

Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain multiple related targets and an appropriate combination can maximize benefits while minimizing adverse reactions.As such,it is especially important to derive mathematical models for their quantitative calculation.In this paper,we introduce mathematical rules for the synergistic,additive,and antagonistic effects of multi-drug combinations developed in our laboratory.We have established a“onebelt,one-line”model and provide examples of the quantitative calculation of the synergistic,additive,and antagonistic effects of a combination of multiple components.We also explain how to scientifically and precisely determine the intensity of these synergies,additions and antagonisms,as well as their corresponding dose ranges,thereby laying a solid theoretical foundation for market listing combinatorial drugs and foods for special medical purposes.

Effectiveness of an amino acid beverage formulation in diarrheapredominant irritable bowel syndrome:A pragmatic real-world study

BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.

Safety and efficacy of Profermin~to induce remission in ulcerative colitis

AIM:To test the efficacy and safety of Profermin in inducing remission in patients with active ulcerative colitis(UC).METHODS:The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index(SCCAI)>4 and<12(median:7.5),who were treated open-label with Profermintwice daily for 24 wk.Daily SCCAI was reported observer blinded via the Internet.RESULTS:In an intention to treat(ITT)analysis,the mean reduction in SCCAI score was 56.5%.Of the 39 patients,24(62%)reached the primary endpoint,which was proportion of patients with≥50%reduction in SCCAI.Our secondary endpoint,the proportion of patients in remission defined as SCCAI≤2.5,was in ITT analysis reached in 18 of the 39 patients(46%).In a repeated-measure regression analysis,the estimated mean reduction in score was 5.0 points(95%CI:4.1-5.9,P<0.001)and the estimated mean time taken to obtain half the reduction in score was 28 d(95%CI:26-30).There were no serious adverse events(AEs)or withdrawals due to AEs.Profermin was generally well tolerated.CONCLUSION:Profermin is safe and may be effective in inducing remission of active UC.

Investigating Factors Influencing the Stability of Enteral Nutritional Emulsions Designed for Cancer Patients

Objective A commercially available reference product was“re-engineered”and the target emulsion was formulated to contain the same energy density,as well as the same percentage of energy sources,as the reference product.The particle size and distribution,polydispersity index(PDI),and zeta-potential of emulsions were measured as indices to analyse the quality of the emulsions.Methods The centrifugal stability(Ke)was examined as the main measure of the stability of the target emulsion.Critical parameters affecting the stability of emulsions were also determined,while the temperature was fixed at 30℃,shear speed at 3500 r/min,and shear time was 15 min.The optimal quantity of emulsifier was also studied in the crude homogenate.Results A relatively stable emulsion could be obtained by using PC-50 at a dosage of 2%as the emulsifier.A 2∶1 proportion of whey protein to casein,a 1∶1 proportion of maltodextrin(DE 10-15)to maltodextrin(DE 15-20)and medium chain triglyceride(MCT)in powder form were used to obtain the most desirable emulsion.Conclusion This study explored the critical parameters that influence the stability of a total nutrition enteral emulsion designed for cancer patients,providing useful information for further industrialisation of this and other emulsion products.