Randomized, Parallel, Double Blinded, Placebo-controlled Study for the Evaluation of the Effectiveness on Visceral Fat Accumulation in Individuals With Abdominal Obesity of a Specific Probiotic Compound
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Change of abdominal visceral fat
研究概览
简要总结
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
详细描述
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
Participants: 129 men and women with a waist circumference ≥102 cm (men) or ≥88 cm (women), randomly assigned to one of 3 treatment groups in parallel: one group (43 members) with active probiotic, another one with the probiotic inactivated by heat, and the last group with the placebo.
Treatment consists of product consumption study for 12 weeks, taking 1 capsule per day. 4 visits during the study, a pre-inclusion visit and 3 study visits (weeks 1, 6, and 12) will be scheduled.
Secondary objectives are to asses the probiotic's effects on:
- the accumulation of subcutaneous body fat and body weight, body mass index (BMI) and waist circumference.
- glucose metabolism and insulin resistance.
- blood lipid profile.
- blood pressure.
- inflammation.
- circulating levels of adiponectin and leptin.
- changes in the intestinal microbiome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults men or women (>18 years old)
- •Waist circumference ≥102 cm (men) or ≥88 cm (women) and <150cm
- •Written informed consent provided before the initial screening visit.
排除标准
- •Use of antibiotics within 30-days period before the study
- •Waist circumference other than those specified in inclusion criteria
- •Body mass index (BMI) ≥ 40 kg/m2
- •Glucose (fasting state) ≥ 126 mg/dL
- •Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
- •Suffer from claustrophobia (to the extent that precludes NMR).
- •Wear pacemakers, electrical stimulators or cochlear implants (NMR contraindications)
- •Following a hypocaloric diet and/or receiving pharmacologic treatment for weight loss
- •Having eating disorders.
- •Use of medication, antioxidant, or multi-vitamin supplements interfering with the study
- •Chronic gastrointestinal pathology
- •Being intolerant or suffer from allergy to any of the products of the study.
- •Pregnant or intending to become pregnant
- •Being in breastfeeding period.
- •Chronic alcoholism
- •Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- •Failing to follow study guidelines.
结局指标
主要结局
Change of abdominal visceral fat
时间窗: Change from 0 weeks (V1) to 12 weeks (V3)
abdominal visceral fat will be measured by Nuclear Magnetic Resonance (NMR). The study will be conducted in 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
次要结局
- Change of Waist circumference(Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3))
- Change of BMI(Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3))
- Change of Abdominal subcutaneous fat(Change from 0 weeks (V1) to 12 weeks (V3))
- Change of body weight(Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3))