Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.
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ABSTRACT: Objectives
To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.Methods
240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.Conclusions
If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.
SUBMITTER: Palacios C
PROVIDER: S-EPMC7484365 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundRecruitment and retention in longitudinal nutrition intervention studies among children is challenging and scarcely reported. This paper describes the strategies and lessons learned from a 1-year randomized double-blind placebo-controlled trial among pre-adolescent children on the effects of soluble corn fiber (SCF) on bone indices (PREBONE-Kids).MethodsParticipants (9-11 years old) were recruited and randomized into 4 treatment groups (600 mg calcium, 12 g SCF, 12 g SCF plus 600 mg calcium and placebo). Interventions were consumed as a fruit-flavored powdered drink for 1-year. School-based recruitment was effective due to support on study benefits from parents and teachers, peer influence and a 2-weeks study run-in for participants to assess their readiness to commit to the study protocol. Retention strategies focused on building rapport through school-based fun activities, WhatsApp messaging, providing health screening and travel reimbursements for study measurements. Compliance was enhanced by providing direct on-site school feeding and monthly non-cash rewards. Choice of 2 flavors for the intervention drinks were provided to overcome taste fatigue. Satisfaction level on the manner in which the study was conducted was obtained from a voluntary sub-set of participants.ResultsThe study successfully enrolled 243 participants within 6 months and retained 82.7% of the participants at the end of 1 year, yielding a drop-out rate of 17.3%. Compliance to the intervention drink was 85% at the start and remained at 78.7% at the end of 1 year. More than 95% of the participants provided good feedback on intervention drinks, rapport building activities, communication and overall study conduct.ConclusionSuccessful strategies focused on study benefits, rapport building, frequent communication using social media and non-cash incentives helped improved compliance and retention rate. The lessons learned to maintain a high retention and compliance rate in this study provide valuable insights for future studies in a similar population.
| S-EPMC8233130 | biostudies-literature
Project description: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.
| S-EPMC7231297 | biostudies-literature
Project description:ObjectiveTo determine the effectiveness of vitamin D supplementation for improving bone mineral density in children and adolescents and if effects vary with factors such as vitamin D dose and vitamin D status.DesignSystematic review and meta-analysis.Data sourcesCochrane Central Register of Controlled Trials, Medline (1966 to present), Embase (1980 to present), CINAHL (1982 to present), AMED (1985 to present), and ISI Web of Science (1945 to present), last updated on 9 August 2009, and hand searching of conference abstracts from key journals. Study selection Placebo controlled randomised controlled trials of vitamin D supplementation for at least three months in healthy children and adolescents (aged 1 month to <20 years) with bone density outcomes. Two authors independently assessed references for inclusion and study quality and extracted data.Data synthesisStandardised mean differences of the percentage change from baseline in bone mineral density of the forearm, hip, and lumbar spine and total body bone mineral content in treatment and control groups. Subgroup analyses were carried out by sex, pubertal stage, dose of vitamin D, and baseline serum vitamin D concentration. Compliance and allocation concealment were also considered as possible sources of heterogeneity.ResultsFrom 1653 potential references, six studies, totalling 343 participants receiving placebo and 541 receiving vitamin D, contributed data to meta-analyses. Vitamin D supplementation had no statistically significant effects on total body bone mineral content or on bone mineral density of the hip or forearm. There was a trend to a small effect on lumbar spine bone mineral density (standardised mean difference 0.15, 95% confidence interval -0.01 to 0.31; P=0.07). Effects were similar in studies of participants with high compared with low serum vitamin D levels, although there was a trend towards a larger effect with low vitamin D for total body bone mineral content (P=0.09 for difference). In studies with low serum vitamin D, significant effects on total body bone mineral content and lumbar spine bone mineral density were roughly equivalent to a 2.6% and 1.7% percentage point greater change from baseline in the supplemented group.ConclusionsIt is unlikely that vitamin D supplements are beneficial in children and adolescents with normal vitamin D levels. The planned subgroup analyses by baseline serum vitamin D level suggest that vitamin D supplementation of deficient children and adolescents could result in clinically useful improvements, particularly in lumbar spine bone mineral density and total body bone mineral content, but this requires confirmation.
| S-EPMC3026600 | biostudies-literature
Project description:ObjectivesTo assess the effectiveness of calcium supplementation for improving bone mineral density in healthy children and to determine if any effect is modified by other factors and persists after supplementation stops.DesignMeta-analysis.Data sourcesElectronic bibliographic databases, hand searching of conference proceedings, and contacting authors for unpublished data.Review methodsWe included randomised placebo controlled trials of calcium supplementation in healthy children that lasted at least three months and had bone outcomes measured after at least six months of follow-up. Two reviewers independently extracted data and assessed quality. Meta-analyses predominantly used fixed effects models with outcomes given as standardised mean differences.ResultsWe included 19 studies involving 2859 children. Calcium supplementation had no effect on bone mineral density at the femoral neck or lumbar spine. There was a small effect on total body bone mineral content (standardised mean difference 0.14, 95% confidence interval 0.01 to 0.27) and upper limb bone mineral density (0.14, 0.04 to 0.24). This effect persisted after the end of supplementation only at the upper limb (0.14, 0.01 to 0.28). There was no evidence that sex, baseline calcium intake, pubertal stage, ethnicity, or level of physical activity modified the effect.ConclusionsThe small effect of calcium supplementation on bone mineral density in the upper limb is unlikely to reduce the risk of fracture, either in childhood or later life, to a degree of major public health importance.
| S-EPMC1602024 | biostudies-literature
Project description:BackgroundPostmenopausal women exhibit higher rates of disability and cardiovascular disease (CVD) with aging compared to men. Whereas habitual exercise training is a known strategy to enhance physiologic function in men and premenopausal women, exercise-related adaptations are often modest in postmenopausal women. We propose dietary nitrate (beetroot juice) administered prior to exercise training may be a feasible approach to improve mobility and cardio-metabolic health outcomes in postmenopausal women.MethodsOur randomized, placebo-controlled study aims to determine preliminary effects sizes for changes in functional mobility and endothelium-dependent vasodilation across three study arms: exercise only (EX), exercise + placebo (EX + PL), and exercise + beetroot (EX + BR). Thirty-six postmenopausal women are recruited in small cohorts wherein group exercise is implemented to facilitate social support and adherence to an 8-week training progression. Participants are randomized to one of three study arms (n = 12 per group) following baseline assessments. Post-intervention assessments are used to determine pre-post changes in outcome measures including distance covered during a 6 min walk test, walking economy, muscle speed and power, and endothelial-dependent vasodilation as determined by flow-mediated dilation. Measures of feasibility include recruitment, retention, adherence to exercise prescription, perceived exercise session difficulty, and adverse event rates.DiscussionEvidence-based, translational strategies are needed to optimize exercise training-related adaptations in postmenopausal women. Findings will inform larger randomized clinical trials to determine if pre-exercise consumption of beetroot juice is an efficacious strategy to promote mobility and attenuate CVD disease risk.
| S-EPMC7773568 | biostudies-literature
Project description:The use of non-pharmacological alternatives to pharmacological interventions, e.g., nutritional therapy, to improve or maintain bone mineral density (BMD) in postmenopausal women has gained traction over the past decade, but limited data exist regarding its efficacy. This paper describes the design of the Prune Study, a randomized controlled trial (RCT) that explored the effectiveness of a 12-month intervention of daily prune consumption on bone density, bone structure and strength estimates, bone turnover, various biomarkers of immune function, inflammation, and cardiovascular health, as well as phenolic and gut microbiota analyses. Postmenopausal women between the ages of 55-75 years were randomized into either control group (no prune consumption; n = 78), 50g prune (50g prune/day; n = 79), or 100g prune (100g prune/day; n = 78). All participants received 1200 mg calcium +800 IU vitamin D3 daily as standard of care. The Prune Study is the largest and most comprehensive investigation of a dose response of prune consumption on bone health, biomarkers of immune function, inflammation, and cardiovascular health, as well as detailed phenolic and gut microbiota analyses in postmenopausal women. 235 women were randomized and 183 women completed the entire study. The findings of this study will help expand our current understanding of clinical implications and mechanisms underlying the resultant health effects of prune as a functional food therapy.
| S-EPMC9163423 | biostudies-literature
Project description:INTRODUCTION:Our previous study-level (aggregate data) meta-analysis suggested that vitamin D supplements may be beneficial for bone density specifically in children with vitamin D deficiency. However, the misclassification of vitamin D status inherent in study-level data means that the results are not definitive and cannot provide an accurate assessment of the size of any effect. Therefore, we propose to undertake an individual patient data (IPD) meta-analysis to determine whether the effect of vitamin D supplementation on bone density in children differs according to baseline vitamin D status, and to specifically estimate the effect of vitamin D in children who are vitamin D deficient. METHODS AND ANALYSIS:This study has been designed to adhere to the Preferred Reporting Items for Systematic Review and Meta-Analyses of IPD statement. We will include randomised placebo-controlled trials of vitamin D supplementation reporting bone density outcomes at least 6 months after the study commenced in children and adolescents (aged <20 years) without coexistent medical conditions or treatments causing osteoporosis. We will update the search of the original review to cover the period 2009-2017, using the same methods as the original review. Fully anonymised data on all randomised patients will be requested. Outcomes will be femoral neck, total hip, lumbar spine and proximal and distal forearm bone mineral density, and total body bone mineral content. A two-stage IPD meta-analysis will be used to examine the effect of baseline serum 25-hydroxyvitamin D (25(OH)D) on treatment effect for each bone density outcome. Restricted maximum likelihood will be used to estimate the random-effects meta-analysis models, with 95% CI for summary effects. Heterogeneity will be assessed by I2 and potential publication bias (small-study effects) and availability bias by funnel plots, Egger's test and Peter's test. ETHICS AND DISSEMINATION:Ethics approval will not be required as the data are to be used for the primary purpose for which they were collected and all original individual studies had ethics approval. Results of the IPD meta-analysis will be submitted for publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42017068772.
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Project description:This research tested the hypothesis that xylanase modulates microbial communities within the large intestine of growing pigs fed corn-based fiber through a stimbiotic mechanism(s) of action (MOA). Sixty gilts were blocked by initial body weight, individually housed, and randomly assigned to one of four dietary treatments (n = 15): a low-fiber (LF) control, a high-fiber (HF) control containing 30% corn bran, HF+100 mg/kg xylanase (HF+XY), and HF+50 mg/kg arabinoxylan-oligosaccharide (HF+AX). Pigs were fed dietary treatments for 46 days. On day 46, pigs were euthanized, and mucosa and lumen contents were collected from the cecum and the colon. The V4 region of 16S rRNA genes was sequenced and clustered into 5,889, 4,657, 2,822, and 4,516 operational taxonomic units (OTUs), in the cecal contents and mucosa and colonic contents and mucosa, respectively. In cecal contents, HF+XY increased measures of α-diversity compared to LF (p < 0.001). Relative to LF, HF increased the prevalence of 44, 36, 26, and 8, and decreased 19, 9, 21, and 10, of the 200 most abundant OTUs from the cecal contents and mucosa and colonic contents and mucosa, respectively (Q < 0.05). Compared to LF, HF increased the abundance of OTUs from the Treponema_2, Ruminococcus_1 genera, from the Lachnospiraceae, Ruminococcaceae, and Prevotellaceae families. In contrast, relative to LF, HF decreased Turicibacter and Lactobacillus in the cecal contents, and Megasphaera and Streptococcus in the mucosa. Relative to HF, HF+XY increased 32, 16, 29, and 19 and decreased 27, 11, 15, and 10 of the 200 most abundant OTUs from the cecal contents and mucosa and colonic contents and mucosa, respectively (Q < 0.05). The addition of xylanase to HF further increased the abundance of OTUs from the Lachnospiraceae and Ruminococcaceae families across the large intestine. Compared to HF, HF+XY increased the abundance of Lactobacillus, Bifidobacterium, and Faecalibacterium among all locations (Q < 0.05). However, HF+AX did not increase the prevalence of these genera in the large intestine. Supplementing xylanase to HF increased hidden-state predictions of microbial enzymes associated with arabinoxylan degradation, xylose metabolism, and short-chain fatty acid production. These data suggest xylanase elicits a stimbiotic MOA in the large intestine of pigs fed corn-based fiber.
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Project description:BackgroundGestational diabetes mellitus (GDM) is a growing public health concern and maternal obesity and poor dietary intakes could be implicated. Dietary polyphenols and fiber mitigate the risk of diabetes and its complications, but little is known about their efficacy in preventing GDM.ObjectivesWe examined the effects of whole blueberry and soluble fiber supplementation on primary outcomes of cardiometabolic profiles in women at high risk of developing GDM.MethodsWomen (n = 34; mean ± SD age: 27 ± 5 y; BMI: 35.5 ± 4.0 kg/m2; previous history of GDM ∼56%; Hispanic ∼79%) were recruited in early pregnancy (<20 weeks of gestation) and randomly assigned to 1 of the following 2 groups for 18 wk: intervention (280 g whole blueberries and 12 g soluble fiber per day) and standard prenatal care (control). Both groups received nutrition education and maintained 24-h food recalls throughout the study. Data on anthropometrics, blood pressure, and blood samples for biochemical analyses were collected at baseline (<20 weeks), midpoint (24-28 weeks), and end (32-36 weeks) of gestation. Diagnosis of GDM was based on a 2-step glucose challenge test (GCT). Data were analyzed using a mixed-model ANOVA.ResultsMaternal weight gain was significantly lower in the dietary intervention than in the control group at the end of the trial (mean ± SD: 6.8 ± 3.2 kg compared with 12.0 ± 4.1 kg, P = 0.001). C-reactive protein was also lower in the intervention than in the control group (baseline: 6.1 ± 4.0 compared with 6.8 ± 7.2 mg/L; midpoint: 6.1 ± 3.7 compared with 7.5 ± 7.3 mg/L; end: 5.5 ± 2.2 compared with 9.5 ± 6.6 mg/L, respectively, P = 0.002). Blood glucose based on GCT was lower in the intervention than in the control (100 ± 33 mg/dL compared with 131 ± 40 mg/dL, P < 0.05). Conventional lipids (total, LDL, and HDL cholesterol and triglycerides) did not differ between groups over time. No differences were noted in infant birth weight.ConclusionsWhole blueberry and soluble fiber supplementation may prevent excess gestational weight gain and improve glycemic control and inflammation in women with obesity.This trial was registered at clinicaltrials.gov as NCT03467503.
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Project description:Supplemental n-3 polyunsaturated fatty acids (PUFA) on bone metabolism have yielded inconsistent results. This study aimed to examine the effects of n-3 PUFA supplementation on bone metabolism markers and bone mineral density through a meta-analysis of randomized controlled trials. A systematic literature search was conducted using the PubMed, Web of Science, and EBSCO databases, updated to 1 March 2023. The intervention effects were measured as standard mean differences (SMD) and mean differences (MD). Additionally, n-3 PUFA with the untreated control, placebo control, or lower-dose n-3 PUFA supplements were compared, respectively. Further, 19 randomized controlled trials (RCTs) (22 comparisons, n = 2546) showed that n-3 PUFA supplementation significantly increased blood n-3 PUFA (SMD: 2.612; 95% CI: 1.649 to 3.575). However, no significant effects were found on BMD, CTx-1, NTx-1, BAP, serum calcium, 25(OH)D, PTH, CRP, and IL-6. Subgroup analyses showed significant increases in femoral neck BMD in females (0.01, 95% CI: 0.01 to 0.02), people aged <60 years (0.01, 95% CI: 0.01 to 0.01), and those people in Eastern countries (0.02, 95% CI: 0.02 to 0.03), and for 25(OH)D in people aged ≥60 years (0.43, 95% CI: 0.11 to 0.74), treated with n-3 PUFA only (0.36, 95% CI: 0.06 to 0.66), and in studies lasting ≤6 months (0.29, 95% CI: 0.11 to 0.47). NTx-1 decreased in both genders (-9.66, 95% CI: -15.60 to -3.71), and serum calcium reduction was found in studies lasting >6 months (-0.19, 95% CI: -0.37 to -0.01). The present study demonstrated that n-3 PUFA supplementation might not have a significant effect on bone mineral density or bone metabolism markers, but have some potential benefits for younger postmenopausal subjects in the short term. Therefore, additional high-quality, long-term randomized controlled trials (RCTs) are warranted to fully elucidate the potential benefits of n-3 PUFA supplementation, as well as the combined supplementation of n-3 PUFA, on bone health.
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