NCT02962583已完成2 期
The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants: A Randomized, Double-blind, Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change from Baseline body weight at 12 weeks
研究概览
简要总结
Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. The purpose of this study is to evaluate the effects of addition of a probiotic supplementation to a weight loss intervention on body weight, body composition and overall health in overweight adults.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 55 years
- •BMI between 27.0 and 39.9 kg/m2
- •Sedentary to moderate active (less than 30 minutes of physical activity, 3 times per week)
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits
- •Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substance for body weight control
- •Willingness and ability to provide informed consent in French
- •Willingness to receive random assignment to probiotic or placebo supplementation
- •Committed to losing weight over the 12-week study period
排除标准
- •Use of another investigational product within three months of the pre-baseline period.
- •Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
- •Women of child-bearing potential not using effective contraception which include:
- •Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants
- •Intrauterine devices (IUD) or Intrauterine system (IUS)
- •Tubal ligation
- •Vasectomy of partner
- •Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- •Positive pregnancy test in women of child-bearing potential
- •Menopausal women
- •Allergic to milk, soy, or yeast
- •Weight gain or loss of at least 10 lbs in previous three months
- •Inflammatory bowel syndrome, celiac disease, short bowel syndrome, or any other malabsorptive syndrome
- •Uncontrolled angina within the past six months
- •Insulin-dependent diabetes (oral medications are not exclusionary)
- •Serious and/or unstable medical conditions (e.g. cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.)
- •Cancer treatment (radiation, chemotherapy, surgery) within past six months or any other treatment or condition known to weaken the immune system (such as systemic corticosteroids or HIVIAIDS).
- •Any physical condition deemed likely to significantly interfere with individuals' ability to participate in a nutritional intervention.
- •Currently or at any point during the study participating in Weight Watcher's or another weight loss program or taking a medication for weight loss.
- •Under antibiotics or treatments (medication or nutritional program) affecting body weight Intake and/or energy expenditure
- •History of drug or alcohol (> 9 drinks weekly) abuse
- •Abnormal thyroid hormone levels
- •Immune-compromised conditions
- •Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
研究组 & 干预措施
Probiotic
Experimental
Daily probiotic consumption
干预措施: Weight loss (Other)
Probiotic
Experimental
Daily probiotic consumption
干预措施: Probiotic Formula (Drug)
Placebo
Placebo Comparator
Daily placebo consumption
干预措施: Weight loss (Other)
Placebo
Placebo Comparator
Daily placebo consumption
干预措施: Placebos (Drug)
结局指标
主要结局
Change from Baseline body weight at 12 weeks
时间窗: 12 weeks
次要结局
- Change from Baseline lipopolysaccharide (LPS) at 12 weeks(12 weeks)
- Change from Baseline interleukin-6 at 12 weeks(12 weeks)
- Change from Baseline BMI at 12 weeks(12 weeks)
- Change from Baseline waist circumference data at 12 weeks(12 weeks)
- Change from Baseline sagittal abdominal diameter data at 12 weeks(12 weeks)
- Change from Baseline body composition at 12 weeks(12 weeks)
- Change from Baseline stress level at 12 weeks(12 weeks)
- Change from Baseline anxiety level at 12 weeks(12 weeks)
- Change from Baseline depression symptoms at 12 weeks(12 weeks)
- Change from Baseline sleeping habits at 12 weeks(12 weeks)
- Change from Baseline intestinal microbiota composition at 12 weeks(12 weeks)
- Change from Baseline C-reactive protein at 12 weeks(12 weeks)
- Change from Baseline TNF-a at 12 weeks(12 weeks)
研究者
研究点 (1)
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