NCT05440630撤回不适用
Efficacy and Safety of Probiotic Strain Bifidobacterium Animalis Subsp. Lactis CECT 8145 Probiotic in the Reduction of Abdominal/Visceral Fat in Overweight and Obese Patients: Double-blind, Randomised, Placebo-controlled Trial
The Archer-Daniels-Midland Company2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Change in abdominal/visceral fat area
研究概览
简要总结
The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
详细描述
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects from 18 to 65 years old.
- •Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)
- •Waist circumference ≥ 102 cm for men
- •Waist circumference ≥ 88 cm for women
- •Signature of the informed consent letter.
- •Agreement to comply with the protocol and study restrictions
排除标准
- •Diagnosed and pharmacologically-treated type 1 or type 2 diabetes
- •Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease
- •Immunosuppression or ongoing therapy causing immunosuppression
- •Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia
- •Subjects consuming antibiotics in the previous 2 months
- •Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
- •History of chronic active inflammatory disorders
- •History of bariatric surgery
- •History of any chronic gastrointestinal disease (e.g. IBD).
- •Known hypersensitivity to any ingredients in the active or placebo products.
结局指标
主要结局
Change in abdominal/visceral fat area
时间窗: 0 week to 16 week
Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups.
次要结局
- Change in lipid profile(week 0, week 16)
- Change in systolic and diastolic blood pressure(week 0, week 4, week 8, week 16)
- Change in cortisol levels(week 0, week 16)
- Change in abdominal subcutaneous fat area(0 week to 16 week)
- Changes in glucose profile(week 0, week 16)
- Change in body composition(0 week to 16 week)
- Change in body weight(week 0, week 4, week 8, week 16)
- Change in hip circumference(week 0, week 4, week 8, week 16)
- Change in BMI(week 0, week 4, week 8, week 16)
- Change in waist circumference(week 0, week 4, week 8, week 16)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Probiotics Effects to Initial Periodontal TreatmentChronic PeriodontitisNCT05408364Marmara University30
招募中
4 期
Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)IBS - Irritable Bowel SyndromeNCT05509725Lallemand Health Solutions162
已完成
不适用
Effect of probiotics in the primary prevention of atopic eczemaAtopic dermatitisISRCTN26134979Ministry for Health, Welfare and Family Affairs (South Korea)112
已完成
4 期
Probiotics at the Treatment of Antibiotic Associated DiarrheaAntibiotic-Associated DiarrheaNCT00700557Federal University of Uberlandia70
已完成
不适用
Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac DiseaseCeliac DiseaseNCT01257620Bai, Julio M.D.22