Riedel Sylvia, de Buys Keren, Tshivhase Abegail M, Mendham Amy E, Venter Pieter, Hoosen Fatima, Dugas Lara R, D'Alton Caroline, Rusch Jody A, Southon Bianca, Pheiffer Carmen P, Johnson Rabia, Reddy Tarylee, Yende-Zuma Nonhlanhla, Muller Christo J F, Dave Joel A, Goedecke Julia H
Biomedical Research and Innovation Platform, South African Medical Research Council, Tygerberg, South Africa.
Centre for Cardio-metabolic Research in Africa, Division of Medical Physiology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
PLoS One. 2025 Aug 13;20(8):e0328774. doi: 10.1371/journal.pone.0328774. eCollection 2025.
Despite its commercial availability, its high fibre, vitamin C and polyphenol content, there are limited scientific studies exploring the cardiometabolic effects of Baobab fruit powder (BFP) in humans. Due to its high fibre content, BFP may offer a potential intervention to reduce intestinal barrier dysfunction and therefore mitigate cardiometabolic risk. A randomized, double-blind, placebo-controlled trial will be conducted with 50 apparently healthy participants living with obesity. Participants will consume either 16 g of BFP or an isocaloric placebo daily for 45 days. The primary outcome will be intestinal permeability determined using the urinary lactulose/mannitol test. Secondary outcomes include blood biomarkers in intestinal permeability (lipopolysaccharide (LPS), intestinal fatty acid binding protein (IFABP), soluble cluster of differentiation 14 (sCD14) and LPS-binding protein (LBP)), microbiota diversity and composition and cardiometabolic risk markers including glucose levels, blood lipid profiles and blood pressure. Liver and kidney function will be monitored at baseline, after 2 weeks and following 45 days of consumption as safety outcomes. The study protocol ensures rigorous, weekly monitoring of participant compliance and tolerability, along with careful tracking of potential adverse events. Intention-to-treat analysis and mixed effects models will be employed for statistical analyses. Potential selection bias and participant dropout are addressed through thorough recruitment strategies and predefined sample size calculations. This research will contribute to the growing body of knowledge on dietary interventions in the context of cardiometabolic risk, particularly in populations at risk for developing metabolic disease. South African Clinical Trial Registry - SANCTR, DOH-27-062024-8061; Pan African Clinical Trial Registry - PACTR202308727853680.
尽管猴面包果粉(BFP)已商业化可得,且其纤维、维生素C和多酚含量较高,但探索其对人体心脏代谢影响的科学研究却很有限。由于BFP纤维含量高,它可能提供一种潜在的干预措施,以减少肠道屏障功能障碍,从而降低心脏代谢风险。将对50名明显健康的肥胖参与者进行一项随机、双盲、安慰剂对照试验。参与者将每天食用16克BFP或等热量的安慰剂,持续45天。主要结局将通过尿乳果糖/甘露醇试验测定肠道通透性。次要结局包括肠道通透性的血液生物标志物(脂多糖(LPS)、肠道脂肪酸结合蛋白(IFABP)、可溶性分化簇14(sCD14)和LPS结合蛋白(LBP))、微生物群多样性和组成以及心脏代谢风险标志物,包括血糖水平、血脂谱和血压。作为安全性结局,将在基线、食用2周后和45天后监测肝肾功能。研究方案确保每周严格监测参与者的依从性和耐受性,并仔细跟踪潜在的不良事件。将采用意向性分析和混合效应模型进行统计分析。通过全面的招募策略和预先定义的样本量计算来解决潜在的选择偏倚和参与者退出问题。这项研究将有助于增加关于心脏代谢风险背景下饮食干预的知识体系,特别是在有患代谢疾病风险的人群中。南非临床试验注册中心 - SANCTR,DOH - 27 - 062024 - 8061;泛非临床试验注册中心 - PACTR202308727853680。
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