Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation on Body Composition, Hunger Sensation, Pro/Antioxidant Ratio, Inflammation and Hormonal Lipo-metabolic Biomarkers in Obese Adults: a Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption
研究概览
简要总结
In animals it has been demonstrated that Saccharomyces boulardii decrease low-grade inflammation and fat mass; also Superoxide Dismutase (SOD) decrease low-grade inflammation. Therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the effect of a 60-days S. boulardii and SOD supplementation on circulating markers of inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid profile, glucose, insulin and HOMA-IR, in obese adults (BMI 30-35 kg/m2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •I class of obesity (BMI: 30-35 Kg/m2)
排除标准
- •evidence of heart, kidney or liver disease
- •diagnosis of major depressive disorder
- •current medications for weight loss, for control of cholesterol and triglycerides
- •anti-inflammatory treatments
- •pregrancy of lactation
- •type 1 diabetes mellitus, intestinal inflammatory bowel disease, celiac disease, chronic pancreatitis
- •probiotic/prebiotic treatment in the last 4 weeks
- •antibiotic use within the last 3 months
结局指标
主要结局
Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption
时间窗: Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks
Eating motivation Visual Analogue Scale (pt): a scale from 0 to 10 points. The scale of hunger (question: "how hungry are you?") ranged from the answer "not at all" to "as hungry as I have ever felt"; the scale of fullness (question: "how full are you?") ranged from the answer "not at all" to "as full as I ever felt"; the scale of satiety (question: "how satiated are you?") ranged from "not at all" to "extremely"; the scale of desire (question: "how strong is your desire to eat?") ranged from "very weak" to "very strong"; the scale of prospective consumption (question: "how much do you think you could (or would want to) eat right now) ranged from "nothing at all" to "a very large amount"
Change on concentration of biochemical parameters for hunger sensation and hormonal status
时间窗: Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks
Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml)
Change on concentration of biochemical parameters for glico-metabolic status
时间窗: Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks
Total cholesterol (mg/dL), Low Density Lipoprotein cholesterol (mg/dL), HDL cholesterol (mg/dL), Triglycerides (mg/dL), Apolipoprotein A (mg/dL), Apolipoprotein B (mg/dL), Glycemia (mg/dL), Uric acid (mg/dL)
次要结局
- Change on concentration of biochemical parameters for hormonal status(Changes from baseline biochemical parameters for hormonal status at 8 weeks)
- Change on status of mood assessment(Changes from baseline mood assessment at 8 weeks)
- Change on status of assessment of food preferences(Changes from baseline assessment of food preferences at 8 weeks)
- Change on concentration of biochemical parameters for nutritional status(Changes from baseline biochemical parameters for nutritional status at 8 weeks)
- Change on concentration of biochemical parameters for inflammation and cardiovascular risk(Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks)
- Change on concentration of biochemical parameters for safety(Changes from baseline biochemical parameters for safety at 8 weeks)
- Change on rate of anthropometric measures(Changes from baseline anthropometric measures at 8 weeks)
- Change on rate of body composition(Changes from baseline body composition at 8 weeks)
研究者
Mariangela Rondanelli
Professor
Azienda di Servizi alla Persona di Pavia