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An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and Metabolome in Infants with Cow's Milk Protein Allergy.
Boulangé, CL, Pedersen, HK, Martin, FP, Siegwald, L, Pallejà Caro, A, Eklund, AC, Jia, W, Zhang, H, Berger, B, Sprenger, N, et al
International journal of molecular sciences. 2023;24(14)
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Human milk oligosaccharides (HMO) are important for the establishment and maturation of the early microbiome in infants and as such play a role in modulating immunity. The aim of this double-blind, randomised, controlled study was to evaluate the effect of HMO supplementation of extensively hydrolysed formula (EHF) on the faecal microbiome in infants with cow’s milk protein allergy (CMPA). 194 non-breastfed infants with CMPA were randomised to receive either an HMO supplemented EHF or control EHF until 12 months of age. The HMO supplemented infants displayed a higher abundance of bifidobacteria and slower microbiome maturation compared to controls as well as changes in faecal amino acid degradation and bile acid conjugation. These effects were more pronounced in infants who were started on the intervention before the age of 3 months. The authors concluded that HMO supplementation reversed, in part, the dysbiosis commonly observed in infants with CMPA.
Abstract
Cow's milk protein allergy (CMPA) is a prevalent food allergy among infants and young children. We conducted a randomized, multicenter intervention study involving 194 non-breastfed infants with CMPA until 12 months of age (clinical trial registration: NCT03085134). One exploratory objective was to assess the effects of a whey-based extensively hydrolyzed formula (EHF) supplemented with 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) on the fecal microbiome and metabolome in this population. Thus, fecal samples were collected at baseline, 1 and 3 months from enrollment, as well as at 12 months of age. Human milk oligosaccharides (HMO) supplementation led to the enrichment of bifidobacteria in the gut microbiome and delayed the shift of the microbiome composition toward an adult-like pattern. We identified specific HMO-mediated changes in fecal amino acid degradation and bile acid conjugation, particularly in infants commencing the HMO-supplemented formula before the age of three months. Thus, HMO supplementation partially corrected the dysbiosis commonly observed in infants with CMPA. Further investigation is necessary to determine the clinical significance of these findings in terms of a reduced incidence of respiratory infections and other potential health benefits.
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Probiotic Supplementation Improves Cognitive Function and Mood with Changes in Gut Microbiota in Community-Dwelling Older Adults: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.
Kim, CS, Cha, L, Sim, M, Jung, S, Chun, WY, Baik, HW, Shin, DM
The journals of gerontology. Series A, Biological sciences and medical sciences. 2021;76(1):32-40
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Aging is characterized by progressive decline in biological functions of the organism. Diet is one of the critical lifestyle factors for physical and mental well-being throughout the life span, including later life. The aim of this study was to investigate the effects of probiotics consumption on intestinal and brain health in elders over the age of 65. This study is a randomised, double-blind, placebo-controlled, multicentre trial. All participants, study coordinators, and researchers were blinded throughout the entire study. Sixty-three participants were randomized, with 31 and 32 subjects in the placebo and probiotics group, respectively. Results demonstrate that probiotics have system-wide effects on the gut–brain axis in healthy community-dwelling older adults by promoting cognitive and mental health and changing the gut microbial composition. Authors conclude that their findings provide evidence that probiotics have health-promoting properties as part of a healthy diet in the general population of independently living older adults.
Abstract
Probiotics have been proposed to ameliorate cognitive impairment and depressive disorder via the gut-brain axis in patients and experimental animal models. However, the beneficial role of probiotics in brain functions of healthy older adults remains unclear. Therefore, a randomized, double-blind, and placebo-controlled multicenter trial was conducted to determine the effects of probiotics on cognition and mood in community-dwelling older adults. Sixty-three healthy elders (≥65 years) consumed either placebo or probiotics containing Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI for 12 weeks. The gut microbiota was analyzed using 16S rRNA sequencing and bioinformatics. Brain functions were measured using the Consortium to Establish a Registry for Alzheimer's disease, Satisfaction with life scale, stress questionnaire, Geriatric depression scale, and Positive affect and negative affect schedule. Blood brain-derived neurotrophic factor (BDNF) was determined using enzyme-linked immunosorbent assay. Relative abundance of inflammation-causing gut bacteria was significantly reduced at Week 12 in the probiotics group (p < .05). The probiotics group showed greater improvement in mental flexibility test and stress score than the placebo group (p < .05). Contrary to placebo, probiotics significantly increased serum BDNF level (p < .05). Notably, the gut microbes significantly shifted by probiotics (Eubacterium and Clostridiales) showed significant negative correlation with serum BDNF level only in the probiotics group (RS = -0.37, RS = -0.39, p < .05). In conclusion, probiotics promote mental flexibility and alleviate stress in healthy older adults, along with causing changes in gut microbiota. These results provide evidence supporting health-promoting properties of probiotics as a part of healthy diet in the older adults.
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Probiotic Administration Increases Amino Acid Absorption from Plant Protein: a Placebo-Controlled, Randomized, Double-Blind, Multicenter, Crossover Study.
Jäger, R, Zaragoza, J, Purpura, M, Iametti, S, Marengo, M, Tinsley, GM, Anzalone, AJ, Oliver, JM, Fiore, W, Biffi, A, et al
Probiotics and antimicrobial proteins. 2020;12(4):1330-1339
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The growing trend suggests that more and more people are turning to a plant-based or vegan diet, raising questions on protein adequacy and their absorption from these diets . A diet rich in legumes, nuts, and seeds may offer adequate protein from a vegetarian or vegan diet, but not all plant protein sources offer a complete set of amino acids. Plant proteins, in general, except soy protein, generally contain less leucine, which is a critical branched-chain amino acid involved in the activation of muscle protein synthesis. Probiotic supplementation, particularly Lactobacillus paracasei, has shown a synergetic effect in increasing the absorption and utilisation of plant protein in the gut. Results of this Placebo-Controlled, Randomised, Double-Blind, Multicentre, Crossover Study in fifteen physically active men showed that supplementation of multi-strain probiotics along with plant protein elevated the postprandial levels of essential amino acids and branched-chain amino acids in the blood. Healthcare professionals could use the results of this study to understand how co-administration of multi-strain probiotic supplementation may be of benefit in increasing the absorption of plant protein, especially for those who are on a vegan or plant-based diet and in using it as a nutritional strategy for optimising muscle health.
Abstract
The fate of dietary protein in the gut is determined by microbial and host digestion and utilization. Fermentation of proteins generates bioactive molecules that have wide-ranging health effects on the host. The type of protein can affect amino acid absorption, with animal proteins generally being more efficiently absorbed compared with plant proteins. In contrast to animal proteins, most plant proteins, such as pea protein, are incomplete proteins. Pea protein is low in methionine and contains lower amounts of branched-chain amino acids (BCAAs), which play a crucial role in muscle health. We hypothesized that probiotic supplementation results in favorable changes in the gut microbiota, aiding the absorption of amino acids from plant proteins by the host. Fifteen physically active men (24.2 ± 5.0 years; 85.3 ± 12.9 kg; 178.0 ± 7.6 cm; 16.7 ± 5.8% body fat) co-ingested 20 g of pea protein with either AminoAlta™, a multi-strain probiotic (5 billion CFU L. paracasei LP-DG® (CNCM I-1572) plus 5 billion CFU L. paracasei LPC-S01 (DSM 26760), SOFAR S.p.A., Italy) or a placebo for 2 weeks in a randomized, double-blind, crossover design, separated by a 4-week washout period. Blood samples were taken at baseline and at 30-, 60-, 120-, and 180-min post-ingestion and analyzed for amino acid content. Probiotic administration significantly increased methionine, histidine, valine, leucine, isoleucine, tyrosine, total BCAA, and total EAA maximum concentrations (Cmax) and AUC without significantly changing the time to reach maximum concentrations. Probiotic supplementation can be an important nutritional strategy to improve post-prandial changes in blood amino acids and to overcome compositional shortcomings of plant proteins. ClinicalTrials.gov Identifier: ISRCTN38903788.
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Efficacy and Safety of Lactobacillus Plantarum C29-Fermented Soybean (DW2009) in Individuals with Mild Cognitive Impairment: A 12-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Hwang, YH, Park, S, Paik, JW, Chae, SW, Kim, DH, Jeong, DG, Ha, E, Kim, M, Hong, G, Park, SH, et al
Nutrients. 2019;11(2)
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Mild cognitive impairment (MCI) describes a range of symptoms that impact on cognition and memory, but not to such an extent that it seriously affects a person's day to day life. People with MCI are at higher risk of going on to develop dementia. Consumption of both probiotics and soy beans have been shown to enhance memory function in previous studies on animals and humans. In this Korean study, a randomised, double-blind, placebo-controlled trial, researchers used soybeans that had been fermented with a bacterium called Lactobacillus plantarum C29, a type of bacteria which is found in the traditional Korean food kimchi. One hundred men and women diagnosed with MCI were given capsules containing either 800 mg of dried fermented soybeans or a placebo for 12 weeks. Participants underwent a series of memory and attention tests to measure cognitive function. Researchers also looked at levels of a protein that supports nerve cells, called brain-derived neurotropic factor (BDNF) in the blood, as well as the composition of bacteria in the stool samples of the participants. The group that consumed the fermented soybeans showed greater improvements in the overall cognitive function, especially attention, compared to those who took the placebo. BDNF levels increased in the soybean group but declined in the placebo group. Increases in BDNF were associated with improvements in cognitive function. The results of this clinical trial suggest that fermented soybeans can be safely consumed by people with MCI to enhance cognitive function. The authors suggested that the increase in blood BDNF levels may be partly responsible for the improved cognitive function, and this in turn points to the importance of the so-called gut-brain axis in improving symptoms of MCI.
Abstract
Early intervention using dietary supplements may be effective in alleviating cognitive impairment among individuals with mild cognitive impairment (MCI). This study investigated the efficacy and safety of Lactobacillus plantarum C29-fermented soybean (DW2009) as a nutritional supplement for cognitive enhancement. One hundred individuals with MCI were randomly assigned to take DW2009 (800 mg/day, n = 50) or placebo (800 mg/day, n = 50) for 12 weeks. The primary outcome measure was change in the composite score of cognitive functions related to memory and attention, measured by computerized neurocognitive function tests. Associations between changes in serum brain-derived neurotrophic factor (BDNF) levels and cognitive performance for each treatment group were evaluated. Compared to the placebo group, the DW2009 group showed greater improvements in the combined cognitive functions (z = 2.36, p for interaction = 0.02), especially in the attention domain (z = 2.34, p for interaction = 0.02). Cognitive improvement was associated with increased serum BDNF levels after consumption of DW2009 (t = 2.83, p = 0.007). The results of this clinical trial suggest that DW2009 can be safely administered to enhance cognitive function in individuals with MCI. Increased serum BDNF levels after administering DW2009 may provide preliminary insight into the underlying effects of cognitive improvement, which suggests the importance of the gut-brain axis in ameliorating cognitive deficits in MCI.
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Functional variants in the sucrase-isomaltase gene associate with increased risk of irritable bowel syndrome.
Henström, M, Diekmann, L, Bonfiglio, F, Hadizadeh, F, Kuech, EM, von Köckritz-Blickwede, M, Thingholm, LB, Zheng, T, Assadi, G, Dierks, C, et al
Gut. 2018;67(2):263-270
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Congenital sucrase-isomaltase deficiency (CSID) is a genetic disorder which results in a lower ability to digest certain sugars, resulting in diarrhoea, abdominal pain and bloating, which are also common symptoms of Irritable Bowel Syndrome (IBS). The objective of this study was to test sucrase-isomaltase (SI) gene variants for their potential relevance in IBS. The researchers looked at genetics in several populations with and without IBS. The researchers found that genetic mutations are associated with a 35% reduction in the activity of the SI enzymes. CSID mutations were almost twice as common in IBS patients than healthy controls. The genetic variant 15Phe was associated with diarrhoea, stool frequency and changes in the gut bacteria. The authors concluded that people with SI gene variants associated with reduced enzyme activity are more at risk of IBS. Genetic screening could help to identify individuals at increased risk of IBS, and may lead to more targeted treatment for some people with IBS.
Abstract
OBJECTIVE IBS is a common gut disorder of uncertain pathogenesis. Among other factors, genetics and certain foods are proposed to contribute. Congenital sucrase-isomaltase deficiency (CSID) is a rare genetic form of disaccharide malabsorption characterised by diarrhoea, abdominal pain and bloating, which are features common to IBS. We tested sucrase-isomaltase (SI) gene variants for their potential relevance in IBS. DESIGN We sequenced SI exons in seven familial cases, and screened four CSID mutations (p.Val557Gly, p.Gly1073Asp, p.Arg1124Ter and p.Phe1745Cys) and a common SI coding polymorphism (p.Val15Phe) in a multicentre cohort of 1887 cases and controls. We studied the effect of the 15Val to 15Phe substitution on SI function in vitro. We analysed p.Val15Phe genotype in relation to IBS status, stool frequency and faecal microbiota composition in 250 individuals from the general population. RESULTS CSID mutations were more common in patients than asymptomatic controls (p=0.074; OR=1.84) and Exome Aggregation Consortium reference sequenced individuals (p=0.020; OR=1.57). 15Phe was detected in 6/7 sequenced familial cases, and increased IBS risk in case-control and population-based cohorts, with best evidence for diarrhoea phenotypes (combined p=0.00012; OR=1.36). In the population-based sample, 15Phe allele dosage correlated with stool frequency (p=0.026) and Parabacteroides faecal microbiota abundance (p=0.0024). The SI protein with 15Phe exhibited 35% reduced enzymatic activity in vitro compared with 15Val (p<0.05). CONCLUSIONS SI gene variants coding for disaccharidases with defective or reduced enzymatic activity predispose to IBS. This may help the identification of individuals at risk, and contribute to personalising treatment options in a subset of patients.
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Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis.
Matsuoka, K, Uemura, Y, Kanai, T, Kunisaki, R, Suzuki, Y, Yokoyama, K, Yoshimura, N, Hibi, T
Digestive diseases and sciences. 2018;63(7):1910-1919
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Fermented milk products may improve symptoms in patients with ulcerative colitis (UC). The aim of this B-FLORA study was to assess the ability of a fermented milk product (‘Mil-Mil’) containing Bifidobacterium breve strain Yakult (BFM) to maintain remission in Japanese patients with UC. The study enrolled 195 patients with UC in remission, who were randomised to receive one pack of fermented milk (containing 10 billion BFM and 1 billion Lactobacillus acidophilus) per day, or a placebo, for 48 weeks. Time to relapse was not significantly different between the BFM and placebo groups, neither was the incidence of relapse. Stool samples from a subgroup of patients revealed no changes in the intestinal microbiota in either group, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. The authors concluded that BFM had no effect on time to relapse in UC patients compared with placebo. Future studies should compare the effects of different probiotics, doses and delivery modes, and consider specific patient populations and disease severity.
Abstract
BACKGROUND Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients. AIMS To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC. METHODS This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks. The primary efficacy endpoint was relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC). RESULTS An interim analysis was conducted after inclusion and follow-up of one-third of patients for the first phase of the study (n = 195). Relapse-free survival was not significantly different between the BFM and placebo groups (P = 0.643; hazard ratio 1.16; 95% CI 0.63-2.14, log-rank test), nor was the incidence of relapse. Therefore, the study was discontinued for lack of efficacy. An exploratory analysis of fecal samples from a subgroup of patients revealed no effects of either study beverage on intestinal microbiota, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. Three mild adverse events occurred for which a causal relationship with the study beverage could not be ruled out (placebo: abdominal bloating and stress in one patient; BFM: body odor in one patient). CONCLUSIONS BFM had no effect on time to relapse in UC patients compared with placebo. STUDY REGISTRATION UMIN000007593.
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Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.
Svanevik, M, Risstad, H, Karlsen, TI, Kristinsson, JA, Småstuen, MC, Kolotkin, RL, Søvik, TT, Sandbu, R, Mala, T, Hjelmesæth, J
Obesity surgery. 2018;28(3):606-614
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Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.
Abstract
BACKGROUND The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION Clinical Trials.gov number NCT00821197.
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Phase I/II multicenter ketogenic diet study for adult superrefractory status epilepticus.
Cervenka, MC, Hocker, S, Koenig, M, Bar, B, Henry-Barron, B, Kossoff, EH, Hartman, AL, Probasco, JC, Benavides, DR, Venkatesan, A, et al
Neurology. 2017;88(10):938-943
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Superrefractory status epilepticus (SRSE) is a neurologic emergency that persists despite anti-seizure medication. The ketogenic diet (KD) has been shown to be successful for treating epilepsy and recent retrospective studies suggest KD may be effective for treating SRSE. The aim of this clinical trial was to investigate the feasibility, safety and efficacy of a ketogenic diet on SRSE in adults. After screening, this prospective multi-centre study enrolled 15 participants with SRSE. Participants received a classic ketogenic diet via gastronomy tube. Of the 14 participants whom completed KD treatment SRSE resolved in 11 participants. Five patients ultimately died. This study found KD is feasible in adults with SRSE, and further randomised controlled trials are required to establish comparative safety and efficacy.
Abstract
OBJECTIVE To investigate the feasibility, safety, and efficacy of a ketogenic diet (KD) for superrefractory status epilepticus (SRSE) in adults. METHODS We performed a prospective multicenter study of patients 18 to 80 years of age with SRSE treated with a KD treatment algorithm. The primary outcome measure was significant urine and serum ketone body production as a biomarker of feasibility. Secondary measures included resolution of SRSE, disposition at discharge, KD-related side effects, and long-term outcomes. RESULTS Twenty-four adults were screened for participation at 5 medical centers, and 15 were enrolled and treated with a classic KD via gastrostomy tube for SRSE. Median age was 47 years (interquartile range [IQR] 30 years), and 5 (33%) were male. Median number of antiseizure drugs used before KD was 8 (IQR 7), and median duration of SRSE before KD initiation was 10 days (IQR 7 days). KD treatment delays resulted from intravenous propofol use, ileus, and initial care received at a nonparticipating center. All patients achieved ketosis in a median of 2 days (IQR 1 day) on KD. Fourteen patients completed KD treatment, and SRSE resolved in 11 (79%; 73% of all patients enrolled). Side effects included metabolic acidosis, hyperlipidemia, constipation, hypoglycemia, hyponatremia, and weight loss. Five patients (33%) ultimately died. CONCLUSIONS KD is feasible in adults with SRSE and may be safe and effective. Comparative safety and efficacy must be established with randomized placebo-controlled trials. CLASSIFICATION OF EVIDENCE This study provides Class IV evidence that in adults with SRSE, a KD is effective in inducing ketosis.
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Association Between Single Gene Polymorphisms and Bone Biomarkers and Response to Calcium and Vitamin D Supplementation in Young Adults Undergoing Military Training.
Gaffney-Stomberg, E, Lutz, LJ, Shcherbina, A, Ricke, DO, Petrovick, M, Cropper, TL, Cable, SJ, McClung, JP
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2017;32(3):498-507
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The risk of stress fracture is increased in initial military training (IMT) largely because of unaccustomed activity, resulting in a change in calcium and vitamin D levels. Genetic polymorphisms are variations in a gene that affect the level of gene expression, and bone metabolism and absorption is impacted by this. The primary aim of this randomised, double-blind, placebo controlled trial was to determine whether genes related to Calcium and vitamin D were associated with markers of bone metabolism in 748 young adults entering military training. Participants were randomised to consume bars between meals that were either supplemented with Calcium and vitamin D or placebo that were matched in taste and appearance. Fasting blood samples were taken before and after the 7- to 9-week IMT programme to assess circulating biomarkers and genes. This study found that genetic polymorphisms related to Calcium and vitamin D were associated with vitamin D status and markers of bone metabolism. It also found that genes could predict change in vitamin D absorption levels. Based on these results, the authors conclude this study provides novel insight that helps further understanding between genetics, environment and bone metabolism.
Abstract
Initial military training (IMT) is associated with increased stress fracture risk. In prior studies, supplemental calcium (Ca) and vitamin D provided daily throughout IMT reduced stress fracture incidence, suppressed parathyroid hormone (PTH), and improved measures of bone health compared with placebo. Data were analyzed from a randomized, double-blind, placebo-controlled trial to determine whether single-nucleotide polymorphisms (SNPs) in Ca and vitamin D-related genes were associated with circulating biomarkers of bone metabolism in young adults entering IMT, and whether responses to Ca and vitamin D supplementation were modulated by genotype. Associations between SNPs, including vitamin D receptor (VDR), vitamin D binding protein (DBP), and 1-alpha-hydroxylase (CYP27B1), and circulating biomarkers were measured in fasting blood samples from volunteers (n = 748) starting IMT. Volunteers were block randomized by race and sex to receive Ca (2000 mg) and vitamin D (1000 IU) or placebo daily throughout Army or Air Force IMT (7 to 9 weeks). Total Ca and vitamin D intakes were calculated as the sum of supplemental intake based on intervention compliance and dietary intake. Relationships between SNPs, Ca, and vitamin D intake tertile and change in biomarkers were evaluated in trial completers (n = 391). At baseline, the minor allele of a DBP SNP (rs7041) was positively associated with both 25OHD (B = 4.46, p = 1.97E-10) and 1,25(OH)2 D3 (B = 9.63, p < 0.001). Combined genetic risk score (GRS) for this SNP and a second SNP in the VDR gene (rs1544410) was inversely associated with baseline 25OHD (r = -0.28, p < 0.001) and response to Ca and vitamin D intake differed by GRS (p < 0.05). In addition, presence of the minor allele of a second VDR SNP (rs2228570) was associated with lower P1NP (B = -4.83, p = 0.04) and osteocalcin (B = -0.59, p = 0.03). These data suggest that VDR and DBP SNPs are associated with 25OHD status and bone turnover and those with the highest GRS require the greatest vitamin D intake to improve 25OHD during IMT. © 2016 American Society for Bone and Mineral Research.
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Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial.
Stenman, LK, Lehtinen, MJ, Meland, N, Christensen, JE, Yeung, N, Saarinen, MT, Courtney, M, Burcelin, R, Lähdeaho, ML, Linros, J, et al
EBioMedicine. 2016;13:190-200
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The gut microbiota is associated with obesity but direct evidence of effects of its modulation on body fat mass is meagre. To investigate the effects of a probiotic and a prebiotic intervention on weight management on adult obese between the ages of 16-65. This is a randomized, double-blind, placebo-controlled clinical intervention trial in overweight and obese adults looking extensively into the clinical markers to assess the potential benefits of the probiotics and prebiotics. This clinical trial demonstrates that a probiotic product with or without dietary fiber may help in managing body fat mass and may also reduce waist circumference but prebiotics on its own had no effect on the measured outcomes.
Abstract
BACKGROUND The gut microbiota is interlinked with obesity, but direct evidence of effects of its modulation on body fat mass is still scarce. We investigated the possible effects of Bifidobacterium animalisssp. lactis 420 (B420) and the dietary fiber Litesse® Ultra polydextrose (LU) on body fat mass and other obesity-related parameters. METHODS 225 healthy volunteers (healthy, BMI 28-34.9) were randomized into four groups (1:1:1:1), using a computer-generated sequence, for 6months of double-blind, parallel treatment: 1) Placebo, microcrystalline cellulose, 12g/d; 2) LU, 12g/d; 3) B420, 1010CFU/d in microcrystalline cellulose, 12g/d; 4) LU+B420, 12g+1010CFU/d. Body composition was monitored with dual-energy X-ray absorptiometry, and the primary outcome was relative change in body fat mass, comparing treatment groups to Placebo. Other outcomes included anthropometric measurements, food intake and blood and fecal biomarkers. The study was registered in Clinicaltrials.gov (NCT01978691). FINDINGS There were marked differences in the results of the Intention-To-Treat (ITT; n=209) and Per Protocol (PP; n=134) study populations. The PP analysis included only those participants who completed the intervention with >80% product compliance and no antibiotic use. In addition, three participants were excluded from DXA analyses for PP due to a long delay between the end of intervention and the last DXA measurement. There were no significant differences between groups in body fat mass in the ITT population. However, LU+B420 and B420 seemed to improve weight management in the PP population. For relative change in body fat mass, LU+B420 showed a-4.5% (-1.4kg, P=0.02, N=37) difference to the Placebo group, whereas LU (+0.3%, P=1.00, N=35) and B420 (-3.0%, P=0.28, N=24) alone had no effect (overall ANOVA P=0.095, Placebo N=35). A post-hoc factorial analysis was significant for B420 (-4.0%, P=0.002 vs. Placebo). Changes in fat mass were most pronounced in the abdominal region, and were reflected by similar changes in waist circumference. B420 and LU+B420 also significantly reduced energy intake compared to Placebo. Changes in blood zonulin levels and hsCRP were associated with corresponding changes in trunk fat mass in the LU+B420 group and in the overall population. There were no differences between groups in the incidence of adverse events. DISCUSSION This clinical trial demonstrates that a probiotic product with or without dietary fiber controls body fat mass. B420 and LU+B420 also reduced waist circumference and food intake, whereas LU alone had no effect on the measured outcomes.