LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
This study will investigate a compound of probiotics and prebiotics in females and males with overweight with the aim to evaluate the effect on weight and metabolic markers.
The design is a three month randomized doubled-blinded, three-armed placebo-controlled trial of probiotics for weight loss. Normal dose (2 capsules á 0.4g per day) doubled dose (4 capsules á 0.4g per day), or placebo.
A second, non-blinded, phase with only the compound of probiotics and prebiotics, with tripple dose (6 capsuled á 0.4g per day), will be performed for individuals who had the compound in the first phase.
详细描述
Participants Total number of study participants will be 75-90, consisting of overweight men and women, 18-45 years of age.
Treatment Dietary supplement consisting of probiotic capsules called LB001. It contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram. The placebo is made of rice flour.
Since one of the inclusion criteria is "willingness to lose weight", all study participants, regardless of randomized treatment, will receive general advice regarding healthy lifestyle habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 26.0 - 29,99 kg/m2
- •18-45 years old
- •Willingness to lose weight
排除标准
- •Active weight loss in the last three months
- •The desire for or planned pregnancy upcoming months
- •Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disorder (IBD), gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease)
- •Allergies with previous anaphylactic reactions
- •Abdominal surgery six months prior to inclusion
- •Current or history of eating disorders
- •Extreme or unusual diets for the last three months, which the investigator considers could negatively affect the outcome of the study
- •Psychiatric disorders (e.g., schizophrenia, and other diagnoses that may influence compliance)
- •Drug or alcohol abuse
- •Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study
- •Present or recent usage of other probiotic agents
- •Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance
研究组 & 干预措施
Double dose
Four capsules of probiotics daily. Probiotic capsules contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram.
干预措施: LB001 (Dietary Supplement)
Single dose
Two capsules of probiotics and two capsules of placebo daily. Probiotic capsules contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram.
The placebo is made of rice flour.
干预措施: LB001 (Dietary Supplement)
Placebo
Four capsules containing rice flour will be given to the placebo group daily.
干预措施: LB001 (Dietary Supplement)
结局指标
主要结局
Weight change
时间窗: Baseline, 6-month follow-up
Weight will be measured in kilograms using a scale.
Weight change
时间窗: Baseline, 3-month follow-up
Weight will be measured in kilograms using a scale.
次要结局
- Waist circumference(Baseline, 6-month follow-up)
- HDL(Baseline, 6-month follow-up)
- Triglycerides(Baseline, 9-month follow-up)
- HbA1c(Baseline, 6-month follow-up)
- Waist circumference(Baseline, 3-month follow-up)
- HbA1c(Baseline, 3-month follow-up)
- HDL(Baseline, 3-month follow-up)
- Triglycerides(Baseline, 3-month follow-up)
研究者
Emilia Hagman
Principal Investigator
Karolinska Institutet