Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Visceral Fat
研究概览
简要总结
Purpose: To evaluate the influence of probiotic supplementation on body composition and other markers of health in occupational shift-workers.
Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a shift-working schedule.
Procedures (methods): In a randomized, placebo-controlled intervention, subjects will complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as well as a 6-week intervention period. Prescreening will include written informed consent, a health history questionnaire, baseline anthropometric measures, assessment of resting heart rate, and exercise protocol familiarization. Baseline testing will involve body composition, a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of supplementation that includes 2 electronic contacts, followed by post-testing that will occur in the same fashion as baseline testing.
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
- 22 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, pre-menopausal women
- •Currently employed on a shift-working (rotating, evening, or night) schedule and has maintained this schedule ≥ 6 months prior to enrollment
- •Participant agrees to maintain usual activity lifestyle
- •Participant has a body mass index of ≥25 kg/m2
- •Participant has provided written and dated informed consent to participate in the study
- •Participant is willing and able to comply with the protocol
- •Participant is apparently healthy and free from disease, as determined by a health history questionnaire
- •Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
- •Participant is not currently pregnant and does not desire to become pregnant in the next 8 weeks.
排除标准
- •Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
- •Participant is using, or has used a probiotic supplements within 8 weeks prior to enrollment
- •Participant has lost or gained greater than 8 pounds within the previous 2 months
- •Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
- •Participant had or currently has a self-identified eating disorder
- •Participant is pregnant or plans on becoming pregnant
- •Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)
研究组 & 干预措施
Probiotic
Multi-strain probiotic
干预措施: Probiotic (Dietary Supplement)
Placebo
Maltodextrin placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Visceral Fat
时间窗: 6 weeks
measured by ultrasound
次要结局
- Body Fat(6 weeks)
- Ratio of fat in the abdominal region vs. hip region(6 weeks)
- Lean body mass(6 weeks)