The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 8
- 主要终点
- Difference in body fat mass from baseline to end-of-treatment (6 months)
研究概览
简要总结
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The supplement is ingested once per day for the duration of six months, and participants will attend a follow-up visit one month after the end of the intervention. The study will enroll 232 participants (58 per study arm) in four research centers in southern Finland.
详细描述
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. Preclinical studies have shown that weight gain and insulin resistance may be prevented by oral administration of the probiotic Bifidobacterium animalis ssp. lactis 420. Furthermore, the prebiotic polydextrose has shown efficacy on satiety in clinical settings. The purpose of this study is to investigate the effects of these products, individually and combined, on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The study is conducted at four research clinics in southern Finland. The supplement is provided in a sachet, mixed into a fruit smoothie and ingested once per day for the duration of six months. One month from the end of the intervention participants will attend a follow-up visit. The study will enroll 232 participants, who will be randomized into blocks using a computerized procedure.
After the screening visit, there will be seven study visits (once per month) and one follow-up visit. Visits at months 0, 2, 4, 6 and follow-up are clinic visits, and visits at months 1, 3 and 5 are phone contacts to check compliance and any adverse events.
Clinic visits include the following measurements and samples:
- weight
- blood pressure and heart rate
- blood samples
- returning of food diaries (only during intervention)
- returning of exercise questionnaires and food choice questionnaires (only beginning and end of treatment)
- returning of fecal samples, taken at home by participant
- DXA for body composition analysis
- hip and waist circumference
- brief physical examination (only beginning and end of treatment)
- recording of adverse events and concomitant medication
For compliance check, unused sachets are returned to the clinic and counted. At the follow-up visit participants will receive guidance on exercise and a healthy diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 28.0-34.9
- •Waist to hip ratio: males ≥0.88, females ≥0.83
- •Age 18-65 years
- •Signed informed consent
- •Available for all study visits and phone calls
- •Follows a regular diet that is in agreement with the national dietary recommendations
排除标准
- •Diagnosed type 1 or type 2 diabetes (i.e. fasting plasma glucose ≥ 7 mmol/l and HbA1C ≥ 6.5%)
- •Use of medication for diabetes, dyslipidemia or hypertension
- •Use of laxatives or fiber supplements in the past 6 weeks
- •History of diagnosed coronary heart disease, other significant cardiovascular disease or artificial heart valve
- •History of chronic active inflammatory disorders
- •History of bariatric surgery
- •Use of anti-obesity drugs in the last 3 months
- •Use of anticoagulants
- •Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs
- •Recent (last 2 months) or ongoing antibiotic use
- •Immunosuppression or ongoing therapy causing immunosuppression
- •Use of probiotics more than once a week during the previous 6 weeks
- •Use of vitamin D supplementation:
- •> 50 - <100 µg/day during the previous 2 weeks
- •≥ 100 - <150 µg/day during the previous 2 months
- •≥150 µg/day or above during the previous 12 months
- •Active or recent (last 3 months) participation in a weight loss program or weight change (increase or loss) of 3 kg during the past 3 months
- •Pregnant or planning pregnancy within 6 months or breastfeeding women
- •Participation in a clinical trial with an investigational product or drug within 60 days prior to screening
- •Likeliness to be noncompliant with the protocol
- •Drug or alcohol abuse
- •Allergy to any of the ingredients used in the study
- •Other reasons that, in the opinion of the Investigator makes the subject unsuitable for enrolment
结局指标
主要结局
Difference in body fat mass from baseline to end-of-treatment (6 months)
时间窗: From baseline to end of intervention (6 months)
Measured with dual-energy x-ray absorptiometry (DXA)
次要结局
- Change in BMI (absolute and relative)(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in lean body mass(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in fasting insulin levels(Months 0, 2, 4, 6 and 7 (follow-up))
- Hip Change in waist and/or hip circumference (absolute and relative)(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in inflammatory markers(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in insulin resistance(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in LPS/sCD14 ratio(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in blood lipids(Months 0, 2, 4, 6 and 7 (follow-up))
- Analytical description of faecal microbiota(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in weight (absolute and relative)(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in fasting glucose levels(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in blood pressure(Months 0, 2, 4, 6 and 7 (follow-up))
- Absolute change in body fat mass(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in glycated haemoglobin (HbA1c) in blood(Months 0, 2, 4, 6 and 7 (follow-up))
- Body fat mass in individual regions of the body(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14)(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase(Months 0, 2, 4, 6 and 7 (follow-up))
- Change in energy, fat and fiber intake(Months 0, 2, 4, 6 and 7 (follow-up))