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Efficacy of Mobile-Based Cognitive Behavioral Therapy on Lowering Low-density Lipoprotein Cholesterol Levels in Patients With Atherosclerotic Cardiovascular Disease: Multicenter, Prospective Randomized Controlled Trial.
Li, D, Xu, T, Xie, D, Wang, M, Sun, S, Wang, M, Zhang, S, Yang, X, Zhang, Z, Wang, S, et al
Journal of medical Internet research. 2023;:e44939
Abstract
BACKGROUND Elevated low-density lipoprotein cholesterol (LDL-C) is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). However, low adherence to medication and lifestyle management has limited the benefits of lowering lipid levels. Cognitive behavioral therapy (CBT) has been proposed as a promising solution. OBJECTIVE This trial aimed to evaluate the efficacy of mobile-based CBT interventions in lowering LDL-C levels in patients with ASCVD. METHODS This multicenter, prospective, randomized controlled trial enrolled 300 patients with ASCVD, who were randomly assigned to the mobile-based CBT intervention group and the control group in a ratio of 1:1. The intervention group received CBT for ASCVD lifestyle interventions delivered by WeChat MiniApp: "CBT ASCVD." The control group only received routine health education during each follow-up. The linear regression and logistic regression analyses were used to determine the effects of a mobile-based CBT intervention on LDL-C, triglyceride, C-reactive protein, the score of General Self-Efficacy Scale (GSE), quality of life index (QL-index), and LDL-C up-to-standard rate (<1.8 mmol/L) at the first, third, and sixth months. RESULTS Finally, 296 participants completed the 6-month follow-up (CBT group: n=148; control group: n=148). At baseline, the mean LDL-C level was 2.48 (SD 0.90) mmol/L, and the LDL-C up-to-standard rate (<1.8 mmol/L) was 21.3%. Mobile-based CBT intervention significantly increased the reduction of LDL-C change (%) at the 6-month follow-up (β=-10.026, 95% CI -18.111 to -1.940). In addition, this benefit remained when baseline LDL-C <1.8 mmol/L (β=-24.103, 95% CI -43.110 to -5.095). Logistic regression analysis showed that mobile-based CBT intervention moderately increased the LDL-C up-to-standard rates (<1.8 mmol/L) in the sixth month (odds ratio 1.579, 95% CI 0.994-2.508). For GSE and QL-index, mobile-based CBT intervention significantly increased the change of scores (%) at the 1-, 3-, and 6-month follow-up (all P values <.05). CONCLUSIONS In patients with ASCVD, mobile-based CBT is effective in reducing LDL-C levels (even for those who already had a standard LDL-C) and can improve self-efficacy and quality of life. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100046775; https://www.chictr.org.cn/showproj.aspx?proj=127140.
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Ca:Mg ratio, medium-chain fatty acids, and the gut microbiome.
Fan, L, Zhu, X, Sun, S, Yu, C, Huang, X, Ness, R, Dugan, LL, Shu, L, Seidner, DL, Murff, HJ, et al
Clinical nutrition (Edinburgh, Scotland). 2022;(11):2490-2499
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BACKGROUND & AIMS Ketogenic medium-chain fatty acids (MCFAs) with profound health benefits are commonly found in dairy products, palm kernel oil and coconut oil. We hypothesize that magnesium (Mg) supplementation leads to enhanced gut microbial production of MCFAs and, in turn, increased circulating MCFAs levels. METHODS We tested this hypothesis in the Personalized Prevention of Colorectal Cancer Trial (PPCCT) (NCT01105169), a double-blind 2 × 2 factorial randomized controlled trial enrolling 240 participants. Six 24-h dietary recalls were performed for all participants at the baseline and during the intervention period. Based on the baseline 24-h dietary recalls, the Mg treatment used a personalized dose of Mg supplementation that would reduce the calcium (Ca): Mg intake ratio to around 2.3. We measured plasma MCFAs, sugars, ketone bodies and tricarboxylic acid cycle (TCA cycle) metabolites using the Metabolon's global Precision Metabolomics™ LC-MS platform. Whole-genome shotgun metagenomics (WGS) sequencing was performed to assess microbiota in stool samples, rectal swabs, and rectal biopsies. RESULTS Personalized Mg treatment (mean dose 205.58 mg/day with a range from 77.25 to 389.55 mg/day) significantly increased the plasma levels of C7:0, C8:0, and combined C7:0 and C8:0 by 18.45%, 25.28%, and 24.20%, respectively, compared to 14.15%, 10.12%, and 12.62% decreases in the placebo arm. The effects remain significant after adjusting for age, sex, race and baseline level (P = 0.0126, P = 0.0162, and P = 0.0031, respectively) and FDR correction at 0.05 (q = 0.0324 for both C7:0 and C8:0). Mg treatment significantly reduced the plasma level of sucrose compared to the placebo arm (P = 0.0036 for multivariable-adjusted and P = 0.0216 for additional FDR correction model) whereas alterations in daily intakes of sucrose, fructose, glucose, maltose and C8:0 from baseline to the end of trial did not differ between two arms. Mediation analysis showed that combined C7:0 and C8:0 partially mediated the effects of Mg treatment on total and individual ketone bodies (P for indirect effect = 0.0045, 0.0043, and 0.03, respectively). The changes in plasma levels of C7:0 and C8:0 were significantly and positively correlated with the alterations in stool microbiome α diversity (r = 0.51, p = 0.0023 and r = 0.34, p = 0.0497, respectively) as well as in stool abundance for the signatures of MCFAs-related microbiota with acyl-ACP thioesterase gene producing C7:0 (r = 0.46, p = 0.0067) and C8:0 (r = 0.49, p = 0.003), respectively, following Mg treatment. CONCLUSIONS Optimizing Ca:Mg intake ratios to around 2.3 through 12-week personalized Mg supplementation leads to increased circulating levels of MCFAs (i.e. C7:0 and C8:0), which is attributed to enhanced production from gut microbial fermentation and, maybe, sucrose consumption.
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White common bean extract remodels the gut microbiota and ameliorates type 2 diabetes and its complications: A randomized double-blinded placebo-controlled trial.
Feng, Y, Zhu, J, Wang, Q, Cao, H, He, F, Guan, Y, Li, D, Yan, J, Yang, J, Xia, Y, et al
Frontiers in endocrinology. 2022;13:999715
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Patients with type 2 diabetes (T2D) have a higher risk of macrovascular complications. Intensive glycaemic control reduces microvascular complications and exerts a modest improved effect on macrovascular outcomes. The main aim of this study was to explore the effects of white common bean extract (WCBE) on glucose metabolism and diabetic complications in patients with T2D. This study was a randomised double-blind placebo-controlled trial which enrolled ninety-six patients with T2D aged between 35 and 75 years. Participants were randomly assigned in a 1:2 ratio to the control group and WCBE group. Results showed that WCBE alleviated glucose metabolism dysbiosis and diabetic complication indices. In fact, after 2 months of an intense intervention with a WCBE treatment and in the following two-month maintenance period, the improvements to glycaemic metabolism were preserved. Furthermore, there was notable improvement of the structure of the gut microbiota, especially the enrichment of short-chain fatty acid-producing bacteria and inhibition of opportunistic pathogens. Authors conclude that WCBE may be considered as a novel prebiotic antidiabetic agent for the regulation of glucose metabolism and gut microbiota homeostasis and may slightly ameliorate diabetic complications in patients with T2D.
Abstract
OBJECTIVE Excessive carbohydrate intake is a high risk factor for increased morbidity of type 2 diabetes (T2D). A novel regimen for the dietary care of diabetes that consists of a highly active α-amylase inhibitor derived from white common bean extract (WCBE) and sufficient carbohydrates intake was applied to attenuate T2D and its complications. Furthermore, the role of gut microbiota in this remission was also investigated. METHODS We conducted a 4-month randomized double-blinded placebo-controlled trial. During the intense intervention period, ninety subjects were randomly assigned to the control group (Group C) and WCBE group (Group W). Subjects in Group C were supplemented with 1.5 g of maltodextrin as a placebo. Subjects in Group W took 1.5 g of WCBE half an hour before a meal. Fifty-five participants continued the maintenance intervention receiving the previous dietary intervention whereas less frequent follow-up. The variation in biochemical, vasculopathy and neuropathy indicators and the structure of the fecal microbiota during the intervention was analyzed. RESULT Glucose metabolism and diabetic complications showed superior remission in Group W with a 0.721 ± 0.742% decline of glycosylated hemoglobin after 4 months. The proportion of patients with diabetic peripheral neuropathy (Toronto Clinical Scoring System, TCSS ≥ 6) was significantly lower in Group W than in Group C. Both the left and right sural sensory nerve conduction velocity (SNCV-left sural and SNCV-right sural) slightly decreased in Group C and slightly increased in Group W. Additionally, the abundances of Bifidobacterium, Faecalibacterium and Anaerostipes were higher in Group W, and the abundances of Weissella, Klebsiella, Cronobacter and Enterobacteriaceae_unclassified were lower than those in Group C at month 2. At the end of month 4, Bifidobacterium remained more abundant in Group W. CONCLUSION To our knowledge, this is the first report of improvement to diabetes complications by using a dietary supplement in such a short-term period. The enrichment of SCFA-producing bacteria might be responsible for the attenuation of T2D and its complications. CLINICAL TRIAL REGISTRATION NUMBER http://www.chictr.org.cn/edit.aspx?pid=23309&htm=4, identifier ChiCTR-IOR-17013656.
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Lower Insulin Sensitivity in Newborns With In Utero HIV and Antiretroviral Exposure Who Are Uninfected in Botswana.
Jao, J, Sun, S, Bonner, LB, Legbedze, J, Mmasa, KN, Makhema, J, Mmalane, M, Kgole, S, Masasa, G, Moyo, S, et al
The Journal of infectious diseases. 2022;(11):2002-2009
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BACKGROUND Few data exist on early-life metabolic perturbations in newborns with perinatal HIV and antiretroviral (ARV) exposure but uninfected (HEU) compared to those perinatally HIV unexposed and uninfected (HUU). METHODS We enrolled pregnant persons with HIV (PWH) receiving tenofovir (TDF)/emtricitabine or lamivudine (XTC) plus dolutegravir (DTG) or efavirenz (EFV), and pregnant individuals without HIV, as well as their liveborn infants. Newborns were randomized to receive either zidovudine (AZT) or nevirapine (NVP) postnatal prophylaxis. Preprandial homeostasis model assessment for insulin resistance (HOMA-IR) was assessed at birth and 1 month. Linear mixed models were fit to assess the association between in utero HIV/ARV exposure and average HOMA-IR from birth to 1 month, adjusting for confounders. RESULTS Of 450 newborns, 306 were HEU. HOMA-IR was higher in newborns HEU versus HUU after adjusting for confounders (mean difference of 0.068 in log HOMA-IR, P = .037). Among newborns HEU, HOMA-IR was not significantly different between TDF/XTC/DTG versus TDF/XTC/EFV in utero ARV exposure and between AZT versus NVP newborn postnatal prophylaxis arms. CONCLUSIONS Newborns HEU versus HUU had lower insulin sensitivity at birth and at 1 month of life, raising potential concern for obesity and other metabolic perturbations later in life for newborns HEU. CLINICAL TRIALS REGISTRATION NCT03088410.
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Effects of fructose from apple and honey on serum uric acid in young Chinese: Randomized crossover trials.
Cheng, Y, Zhang, H, Zhu, Y, Xue, Z, Yan, M, Wang, H, Sun, S, Zhang, X
Asia Pacific journal of clinical nutrition. 2022;(1):87-96
Abstract
BACKGROUND AND OBJECTIVES Overconsumption of drinks containing fructose increases the risk for hyperuricemia and gout. Comparative analysis evaluating the indicators of serum uric acid (SUA) load caused by natural food-derived fructose and pure fructose in sweeteners is lacking. We aimed to uncover the effect of fructose from apple and honey and pure fructose powder on the SUA concentration of healthy young Chinese individuals. METHODS AND STUDY DESIGN Two randomized crossover trials were performed. The participants were randomly assigned to consume apple or honey (test food) or pure fructose powder (reference food); one week later, the groups' dietary intervention was switched. Blood samples were collected at 0, 30, 60, and 120 min after meal to measure the SUA and blood glucose concentrations. RESULTS At 30 and 60 min, the SUA concentration in participants consuming apple or honey was lower than in those consuming fructose powder. At 120 min, the SUA concentration of participants consuming apple returned to baseline. The areas under the curve (AUC) within 2 h (2h- AUCs) of SUA exhibited the trend of fructose >honey >apple. The 2h-AUC ratio between test food and reference food was determined using the uric acid index to assess the efficiency of food-derived fructose in increasing the SUA concentration. The uric acid index of honey was higher than that of apple. Men had higher postprandial SUA concentration than women. CONCLUSIONS Food-derived fructose caused a lighter load on uric acid metabolism than pure fructose. Uric acid index can be useful for distinguishing fructose-containing foods.
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Traditional Chinese medicine shenhuang granule in patients with severe/critical COVID-19: A randomized controlled multicenter trial.
Zhou, S, Feng, J, Xie, Q, Huang, T, Xu, X, Zhou, D, Zhang, W, Sun, S, Liu, X, Wu, X, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153612
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BACKGROUND Coronavirus disease 2019 (COVID-19) is still a pandemic, with a high mortality rate in severe/critical cases. Therapies based on the Shenghuang Granule have proved helpful in viral infection and septic shock. HYPOTHESIS/PURPOSE The objective of the current study was to compare the efficacy and safety of the traditional Chinese medicine, Shenhuang Granule, with standard care in hospitalized patients with severe/critical COVID-19. STUDY DESIGN AND METHODS This was an open-label, multicenter, randomized, controlled clinical trial. At 4 medical centers, a total of 111 severe/critical patients were randomly assigned to receive Shenhuang Granule (SHG group) twice a day for 14 days, in addition to standard care, or to receive standard care alone (Control group). The maximal follow up time was 75 days. The clinical endpoint was clinical improvement and mortality. RESULTS 54 patients were assigned to the control group and 57 to the SHG group. The overall mortality was 75.9% (41/54) in the control group, and 38.6% (22/57) in the SHG group (p < 0.01 vs. control). The post hoc analysis showed that in the severe category, the mortality of the control group vs. the SHG group was 58.8% (10/17) vs. 5.3% (1/19) (p < 0.01); while in the critical category, it was 83.8% (31/37) vs. 55.3% (21/38) (p < 0.05). In the severe category, the mortality of patients who eventually received an invasive ventilator in the control vs. the SHG group was 58.8% (10/17) vs. 0 (0/19) (p < 0.01). Administration of SHG was associated with increased lymphocytes and decreased adverse events. CONCLUSION Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
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Non-Energy-Restricted Low-Carbohydrate Diet Combined with Exercise Intervention Improved Cardiometabolic Health in Overweight Chinese Females.
Sun, S, Kong, Z, Shi, Q, Hu, M, Zhang, H, Zhang, D, Nie, J
Nutrients. 2019;(12)
Abstract
This study aimed to examine the effects of four weeks of a low-carbohydrate diet (LC) and incorporated exercise training on body composition and cardiometabolic health. Fifty-eight overweight/obese Chinese females (age: 21.2 ± 3.3 years, body mass index (BMI): 25.1 ± 2.8 kg/m2) were randomly assigned to the control group (CON, n = 15), the LC control group (LC-CON, n = 15), the LC and high-intensity interval training group (LC-HIIT, n = 15), or the LC and moderate-intensity continuous training group (LC-MICT, n = 13). Subjects consumed a four week LC, whereas LC-HIIT and LC-MICT received extra training 5 d/week (LC-HIIT: 10 × 6 s cycling interspersed with 9 s rest, MICT 30 min continuous cycling at 50-60% VO2peak). After intervention, the three LC groups demonstrated significant reductions in body weight (-2.85 kg in LC-CON, -2.85 kg in LC-HIIT, -2.56 kg in LC-MICT, p < 0.001, η2 = 0.510), BMI (p < 0.001, η2 = 0.504) and waist-to-hip ratio (p < 0.001, η2 = 0.523). Groups with extra training (i.e., LC-HIIT and LC-MICT) improved VO2peak by 14.8 and 17.3%, respectively. However, fasting glucose and blood lipid levels remained unchanged in all groups. Short-term LC is a useful approach to improve body composition in overweight/obese Chinese females. Incorporated exercise training has no additional effects on weight loss, but has additional benefits on cardiorespiratory fitness, and HIIT is more time efficient than the traditional MICT (2.5 min vs. 30 min).
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The Effects of High-Intensity Interval Exercise and Hypoxia on Cognition in Sedentary Young Adults.
Sun, S, Loprinzi, PD, Guan, H, Zou, L, Kong, Z, Hu, Y, Shi, Q, Nie, J
Medicina (Kaunas, Lithuania). 2019;(2)
Abstract
Background and Objectives: Limited research has evaluated the effects of acute exercise on cognition under different conditions of inspired oxygenation. Thus, the purpose of this study was to examine the effects of high-intensity interval exercise (HIE) under normoxia (inspired fraction of oxygen (FIO₂): 0.209) and moderate hypoxia (FIO₂: 0.154) on cognitive function. Design: A single-blinded cross-over design was used to observe the main effects of exercise and oxygen level, and interaction effects on cognitive task performance. Methods: Twenty inactive adults (10 males and 10 females, 19⁻27 years old) performed a cognitive task (i.e., the Go/No-Go task) before and immediately after an acute bout of HIE under normoxic and hypoxic conditions. The HIE comprised 10 repetitions of 6 s high-intensity cycling against 7.5% body weight interspersed with 30 s passive recovery. Heart rate, peripheral oxygen saturation (SpO₂) and rating of perceived exertion were monitored. Results: The acute bout of HIE did not affect the reaction time (p = 0.204, η² = 0.083) but the accuracy rate decreased significantly after HIE under both normoxic and hypoxic conditions (p = 0.001, η² = 0.467). Moreover, moderate hypoxia had no influence either on reaction time (p = 0.782, η² = 0.004) or response accuracy (p = 0.972, η² < 0.001). Conclusions: These results indicate that an acute session of HIE may impair response accuracy immediately post-HIE, without sacrificing reaction time. Meanwhile moderate hypoxia was found to have no adverse effect on cognitive function in inactive young adults, at least in the present study.
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Inter-niche and inter-individual variation in gut microbial community assessment using stool, rectal swab, and mucosal samples.
Jones, RB, Zhu, X, Moan, E, Murff, HJ, Ness, RM, Seidner, DL, Sun, S, Yu, C, Dai, Q, Fodor, AA, et al
Scientific reports. 2018;(1):4139
Abstract
The purpose of this study is to evaluate similarities and differences in gut bacterial measurements and stability in the microbial communities of three different types of samples that could be used to assess different niches of the gut microbiome: rectal swab, stool, and normal rectal mucosa samples. In swab-stool comparisons, there were substantial taxa differences with some taxa varying largely by sample type (e.g. Thermaceae), inter-individual subject variation (e.g. Desulfovibrionaceae), or by both sample type and participant (e.g. Enterobacteriaceae). Comparing all three sample types with whole-genome metagenome shotgun sequencing, swab samples were much closer to stool samples than mucosa samples although all KEGG functional Level 1 and Level 2 pathways were significantly different across all sample types (e.g. transcription and environmental adaptation). However, the individual signature of participants was also observed and was largely stable between two time points. Thus, we found that while the distribution of some taxa was associated with these different sampling techniques, other taxa largely reflected individual differences in the microbial community that were insensitive to sampling technique. There is substantial variability in the assessment of the gut microbial community according to the type of sample.
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The CLIMB (Complex Lipids In Mothers and Babies) study: protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring.
Huang, S, Mo, TT, Norris, T, Sun, S, Zhang, T, Han, TL, Rowan, A, Xia, YY, Zhang, H, Qi, HB, et al
BMJ open. 2017;(10):e016637
Abstract
INTRODUCTION Complex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes. METHODS AND ANALYSIS We aim to recruit approximately 1500 pregnant women in the first trimester (11-14 weeks) and randomise them into one of the three treatment groups: standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I). ETHICS AND DISSEMINATION This project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER ChiCTR-IOR-16007700; Pre-results.