Probiotic Regulation of Food Intake Through Satiety Stimulation and Gut Microbiota Modulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Ad libitum food intake
研究概览
简要总结
The goal of this 16-week randomised, placebo-controlled parallel study is to investigate the effect of a newly formed probiotic supplement on satiety and gut microbiota composition in healthy men and women with overweight or obesity form 20-70 years old. The main question it aims to answer is:
Does the probiotic supplement increase feelings of satiety and alter gut microbiota composition?
Participants will:
- Receive a daily dose of 6 g probiotic supplement (packed in sachets of 3 g) or placebo for 16 weeks.
- Visit the research unit 3 times at baseline, week 8 and week 16 of the intervention for blood draws and delivering fecal samples.
- Keep a study diary to report deviations from their daily habits and fill in food questionnaires.
详细描述
Rationale: Satiety hormones, including glucagon-like peptide-1 (GLP-1), are key regulators of food intake. Deficiencies in the release of satiety hormones as well as alterations in the composition and the function of the gut microbiota are hallmarks of overweight and obesity. Probiotics can improve the overall structure of the gut microbiota, and show strain-specific differences with regard to their ability to stimulate satiety hormones. Those animal-based findings, if confirmed in human studies, may pose a gateway for decreased food intake, weight management, and ultimately weight loss. The investigators hypothesise that a newly developed combination of probiotic strains, specifically selected for their potential to (in vitro) influence pathways related to weight management, will decrease food intake through increased release of satiety hormones (i.e. GLP-1) and beneficial alteration of the gut microbiota in humans.
Objective: The primary objective of the study is to investigate the effects of a combination of specifically selected probiotic strains in a new probiotic formulation on ad libitum food intake, in individuals with overweight and/or obesity. The investigators will address this objective firstly with an acute study followed by a proof-of-concept 4-months intervention study comparing a total of 98 individuals in a 16-week randomised, placebo-controlled parallel study (49 participants probiotic/ 49 participants placebo).
Study design: This intervention study will have a randomised, controlled parallel design. The total study duration will be 16 weeks.
Study population: A total of 98 men and women between the ages of 20-70 years old, with overweight/obesity (BMI: 26-40 kg/m2) will be recruited, accounting for a drop-out rate of 20%.
Intervention: Study participants will receive a daily dose of 6 g probiotic supplement (packed in sachets of 3 g) or placebo for 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, aged between 20-70 years
- •BMI ³ 25 kg/m2
- •Stable body weight (weight gain or loss < 3 kg in the past three months)
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- •No difficult venipuncture as evidenced during the screening visit
排除标准
- •Diabetic patients (type 1 and type 2)
- •Abuse of drugs
- •More than 2 units alcoholic consumptions per day for women and 3 for men
- •Use of products or dietary supplements known to interfere with the main outcomes 3 months prior to the start of the study as judged by the principal investigators
- •Gastrointestinal disease (including IBD and IBS)
- •Use of an investigational product within another biomedical intervention trial within the previous 1-month
- •Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, autoimmune disease and rheumatoid arthritis
- •Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- •use of lipid- and glucose lowering medication, corticosteroid use
- •Psychiatric diagnoses including clinical depression
- •Intolerances or dietary habits that might interfere with the study (i.e. lactose intolerance or veganism)
- •pregnancy
- •smoking, vaping
- •use of antibiotics up to 3 months prior to the study
研究组 & 干预措施
Placebo
6g of placebo daily
干预措施: Placebo (Other)
Probiotic supplement
6g of probiotic supplement daily
干预措施: Probiotic supplementation (Dietary Supplement)
结局指标
主要结局
Ad libitum food intake
时间窗: From enrolment to the end of the 16-week intervention
The primary objective of the study is to investigate the effects of a combination of specifically selected probiotic strains in a new probiotic formulation on ad libitum food intake, in individuals with overweight and/or obesity. The primary endpoint is the difference in satiety measured by ad libitum food intake comparing the probiotic and control intervention.
次要结局
- Satiety hormones(From enrolment to the end of the 16-week intervention)
- Subjective Appetite Sensation(From enrolment to the end of the 16-week intervention)
- Fecal microbial composition(From enrolment to the end of the 16-week intervention)
- Diet(From enrolment to the end of the 16-week intervention)
- Physical Activity(From enrolment to the end of the 16-week intervention)
- Insulin resistance(From enrolment to the end of the 16-week intervention)
- Blood pressure(From enrolment to the end of the 16-week intervention)
- Heart rate(From enrolment to the end of the 16-week intervention)
- Lipids(From enrolment to the end of the 16-week intervention)
- Inflammatory markers(From enrolment to the end of the 16-week intervention)
- Body Composition(From enrolment to the end of the 16-week intervention)
- Anthropometric measurements - Body weight(From enrolment to the end of the 16-week intervention)
- Anthropometric measurements - length(From enrolment to the end of the 16-week intervention)
- Anthropometric measurements - waist and hip circumferences(From enrolment to the end of the 16-week intervention)
- Cognitive restrained(From enrolment to the end of the 16-week intervention)
- Disinhibition(From enrolment tot he end of the 16-week intervention)
- Hunger(From enrolment tot he end of the 16-week intervention)
- Quality of life assessment(From enrolment to the end of the 16-week intervention)
- Mental health(From enrolment to the end of the 16-week intervention)
- Mood(From enrolment to the end of the 16-week intervention)
- Stress(From enrolment to the end of the 16-week intervention)
- Sleep characteristics(From enrolment to the end of the 16-week intervention)