A Randomized, Double Blind, Placebo Controlled Trial Design For A Period Of 12 Months

703 Words Apr 26th, 2016 3 Pages
This study will employ a randomized, double-blind, placebo-controlled trial design for a period of 12 weeks with one treatment and one control group. The sample for this study will be recruited from obesity clinic. Participants will include both male and female, aged between 18 and 50 years, with a Body Mass Index or BMI of 30 kg/m2 or above. Participants with hypertension, type 2 diabetes, cardiovascular disease, dyslipidemia, or abnormal thyroid hormone levels will be excluded. Also, Participants who use tobacco, vitamin and mineral supplementation, medication affecting body weight, energy expenditure, or glucose control, or antibiotic treatment for the last 3 months will be excluded. In addition, women with pregnancy, breast-feeding or menopause will be excluded. Demographic information that includes age, gender, weight, height, health conditions will be extracted from the clinic’s medical records. The study will conduct according to the guidelines for human subject research. Written informed consent will be obtained from all the participants.
Participants will randomly divide to two groups. Intervention group will take lactobacillus gasseri supplementation, and control group will take placebo supplements. Intervention’s capsules will compose of 108 CFU of lactobacillus gasseri. All participants have to ingest one capsule 30 min before breakfast and one capsule 30 min before dinner. Participants will receive information about the protocol and explanations about the…

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