Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
研究概览
简要总结
The objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.
详细描述
A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age between 20 and 65 years, nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2). Over a 12 week test period, the probiotic group consumed 2 g of powder twice a day containing L. curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product without probiotics for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Age between 20 and 65 years
- •Nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL)
- •Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)
排除标准
- •Constant consumption of any probiotics products within 1 month before screening
- •Unstable body weight (body weight change > 1 kg within 3 months before screening)
- •Hypertension
- •Type 2 diabetes
- •Cardiovascular disease
- •Cerebrovascular disease
- •Thyroid disease
- •Dietary supplementation within 6 months before screening
- •Pregnancy or breast-feeding
- •Medication affecting body weight, energy expenditure, glucose control or antibiotic treatment within 3 months before screening
- •Acute or chronic infections
- •Liver disease
- •Kidney disease
- •Gastrointestinal disease
- •Medication or alcohol abuse
- •Any other acute or chronic disease requiring treatment
研究组 & 干预措施
Probiotic group
consumed 2 g of powder of a dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032, twice a day after breakfast and dinner.
干预措施: Probiotic group (Dietary Supplement)
Placebo group
consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner.
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
时间窗: 12-week follow-up
Fat percentage (%)
Fat mass by DEXA at baseline and 12-week follow-up
时间窗: 12-week follow-up
Fat mass (g)
Lean body mass by DEXA at baseline and 12-week follow-up
时间窗: 12-week follow-up
Lean body mass (g)
Fat area by computed tomography (CT) at baseline and 12-week follow-up
时间窗: 12-week follow-up
Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra
次要结局
- LDL Cholesterol at baseline and 12-week follow-up(12-week follow-up)
- High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up(12-week follow-up)
- Total Cholesterol at baseline and 12-week follow-up(12-week follow-up)
- Triglyceride at baseline and 12-week follow-up(12-week follow-up)
- HDL Cholesterol at baseline and 12-week follow-up(12-week follow-up)