NCT03934229已完成不适用
The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention: A Randomized, Double-blind, Placebo-controlled, Multi-center Study
Danisco France SAS13 个研究点 分布在 2 个国家目标入组 418 人开始时间: 2019年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 13
- 主要终点
- Total body fat mass relative change
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary, written, signed, informed consent to participate in the study
- •Male or female, age between 20 to 65 (inclusive)
- •BMI between 28.0 and 34.9 (inclusive), of which 1:1 overweight (28.0-29.9):obese (30-34.9)
- •Waist circumference for men of > 102 cm or for women of > 88 cm
- •Agreement to comply with the protocol and study restrictions
- •Access to Internet in addition to willingness and ability to use web-based questionnaires
- •Available for all study visits
- •Females of child-bearing potential required to provide a negative urine pregnancy test and agree to use a medically-approved method of birth control, eg. all of the following are approved: birth control pill, patch, shot, vaginal ring, mini pill, long-acting reversible contraception (LARC) meaning hormonal intrauterine device, nonhormonal intrauterine device with copper, subdermal contraceptive implant, condoms, cervical cap, diaphragm.
- •Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
排除标准
- •Diagnosed and pharmacologically-treated type 1 and type 2 diabetes (fasting blood glucose ≥ 7 mmol/l)
- •Use of medication/supplements for blood glucose control
- •Pharmacologically-treated (medication/supplements) hypertension or dyslipidemia
- •Cardiovascular disease, hypertensive retinopathy, left ventricular dysfunction, secondary hypertension, liver dysfunction/disease, kidney dysfunction/disease, dementia, thyroid disease, pancreatic disease, history of cancer within past 5 years (excluding basal cell carcinoma), anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject
- •Use of drugs or supplements to manage body weight or body fat in the last 3 months
- •Use of laxatives or fiber supplements in the past 6 weeks.
- •History of chronic active inflammatory disorders
- •History of bariatric surgery
- •History of any chronic gastrointestinal disease (e.g. IBD) or disorders (e.g. IBS, constipation, diarrhea), or gastrointestinal reflux disease
- •Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs
- •Regular (more than once per week) use of proton pump inhibitors
- •Recent (last 3 months) or ongoing antibiotic use
- •Immunosuppression or ongoing therapy causing immunosuppression
- •Use of probiotic supplements during the previous 6 weeks
- •Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past 3 months or planned cessation of the use of these products during the trial
- •Use of vitamin D supplementation of ≥100 µg/day
- •Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise)
- •Weight change (increase or loss) of 3 kg during the past 3 months
- •Pregnant or planning pregnancy during the study or breastfeeding
- •Participation in a clinical trial with an investigational product or drug within 60 days prior to screening
- •Likeliness to be noncompliant with the protocol
- •No possibility of contact in case of emergency
- •Illicit drug users
- •Alcohol abusers
- •Administrative or legal supervision
- •Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study
- •Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
- •Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
结局指标
主要结局
Total body fat mass relative change
时间窗: Change from baseline at 6 months
Difference in total body fat mass relative change from baseline (Visit 2) to 6 months of product intake (Visit 5) between the active vs. placebo group
次要结局
- Trunk fat mass change(Change from baseline at 2 months, 4 months and 6 months)
- Android fat mass change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Waist circumference change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Lean body mass change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Energy intake change(Change from baseline at 6 months)
- Total fat mass absolute change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Body weight change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Fat mass change in individual body regions(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- BMI change(Change from baseline at 6 months)
- Hip circumference change(Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5))
- Total fat mass relative change(Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4))
研究者
研究点 (13)
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