Effect of Probiotics on Appetite Regulation in Adults With Overweight/Obesity (ProBiSat)
Probiotic Regulation of Food Intake Through Satiety Stimulation and Gut Microbiota Modulation
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.
研究概览
地位
详细说明
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.
Main study parameters/endpoints: At baseline and after 16 weeks, participants will visit the research facilities for assessments. The primary endpoint is the difference in satiety measured by ad libitum food intake comparing the probiotic and control intervention. Secondary outcome parameters are related to changes in satiety hormones (including GLP-1), fecal microbiota analysis, insulin sensitivity (HOMA-IR), inflammatory markers and lipid metabolism.
Exploratory outcomes concern perceived satiety, body composition and mental health. This study will provide insight into the potential beneficial effect of a newly composed probiotic supplement on satiety in overweight/obese adults.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tanja Adam, PhD
- 电话号码：+31433882123
- 邮箱：t.adam@maastrichtuniversity.nl
研究联系人备份
- 姓名：Iris Boelen, MSc
- 电话号码：+31433883644
- 邮箱：iris.boelen@maastrichtuniversity.nl
学习地点
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Limburg
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Maastricht、Limburg、荷兰、6200MD
- 招聘中
- Maastricht University, Department of Nutrition and Movement Sciences
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首席研究员：
- Tanja Adam, PhD
-
接触：
- Tanja Adam, PhD
- 电话号码：+31433882123
- 邮箱：t.adam@maastrichtuniversity.nl
-
接触：
- Iris Boelen, MSc
- 电话号码：+31 (0)433883644
- 邮箱：iris.boelen@maastrichtuniversity.nl
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Probiotic supplement
6g of probiotic supplement daily
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16-week consumption of 6 g/day of probiotic supplement
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|
安慰剂比较：Placebo
6g of placebo daily
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16-week consumption of 6 g/day of placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ad libitum food intake
大体时间：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.
|
From enrolment to the end of the 16-week intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satiety hormones
大体时间：From enrolment to the end of the 16-week intervention
|
Satiety hormones, GLP-1, PYY, and ghrelin, will be measured in the blood by taking fasted and postprandial blood samples at multiple timepoints.
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From enrolment to the end of the 16-week intervention
|
|
Subjective Appetite Sensation
大体时间：From enrolment to the end of the 16-week intervention
|
Visual Analogue Scales (VAS) will be used to register different aspects of appetite, thirst, and well-being during the test days.
The questions concern hunger, satiety, fullness, thirst, prospective food consumption, and desire to eat.
Using a validated, 100-mm line, participants place a mark on the line between anchors like "not at all" (0 mm) and "extremely" (100 mm).
Appetite sensation will be assessed at 30-minute intervals starting at time -30 until the ad libitum lunch for a total of 240 minutes.
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From enrolment to the end of the 16-week intervention
|
|
Fecal microbial composition
大体时间：From enrolment to the end of the 16-week intervention
|
Stool samples will be collected at home and immediately stored in the freezer at -20°C.
Participants will bring the stool sample to the laboratory, while preserving the cold chain, where samples will be kept in a -80°C freezer until further analysis.
We will profile the gut microbiota composition at baseline and after treatment using 16S rRNA gene amplicon sequencing techniques.
Sequencing data will be processed using our validated in-house Bio-IT pipeline and microbial richness, diversity, community structure and taxonomic composition will be linked to the probiotic intervention as well as treatment outcomes.
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From enrolment to the end of the 16-week intervention
|
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Diet
大体时间：From enrolment to the end of the 16-week intervention
|
Participants will be instructed to continue their usual dietary pattern throughout the intervention period to study the isolated effect of probiotic supplementation.
Before, at week 8 and in the last week of the intervention period, participants' dietary pattern will be assessed by means of a FFQ.
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From enrolment to the end of the 16-week intervention
|
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Physical Activity
大体时间：From enrolment to the end of the 16-week intervention
|
Participants will be instructed to continue their usual physical activity pattern throughout the intervention period to study the isolated effect of probiotic supplementation.
Before, at week 8 and in the last week of the intervention period, participants' physical acitivity pattern will be assessed by means of the SQUASH questionnaire.
|
From enrolment to the end of the 16-week intervention
|
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Insulin resistance
大体时间：From enrolment to the end of the 16-week intervention
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Fasted blood samples for glucose and insulin will be taken to determine the homeostatic model assessment of insulin resistance (HOMA-IR) and beta-cell function.
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From enrolment to the end of the 16-week intervention
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Blood pressure
大体时间：From enrolment to the end of the 16-week intervention
|
Office BP (SBP and DBP) will be determined in four-fold (the first measurement will be discarded, and the last three measurements will be averaged) using a semi continuous blood pressure monitoring device (Omron M7, CEMEX Medische Techniek, Nieuwegein, The Netherlands).
|
From enrolment to the end of the 16-week intervention
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Heart rate
大体时间：From enrolment to the end of the 16-week intervention
|
Heart rate (HR) will be determined in four-fold (the first measurement will be discarded, and the last three measurements will be averaged) using a semi continuous blood pressure monitoring device (Omron M7, CEMEX Medische Techniek, Nieuwegein, The Netherlands).
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From enrolment to the end of the 16-week intervention
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Lipids
大体时间：From enrolment to the end of the 16-week intervention
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Fasting and postprandial serum triacylglycerol (TAG) and total cholesterol (TC) and HDL-C concentrations will be measured.
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From enrolment to the end of the 16-week intervention
|
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Inflammatory markers
大体时间：From enrolment to the end of the 16-week intervention
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Plasma markers related to systemic inflammation will be measured in the blood to assess low-grade systemic inflammatory responses.
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From enrolment to the end of the 16-week intervention
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Body Composition
大体时间：From enrolment to the end of the 16-week intervention
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Measurement of body composition is done by BodPod in a fasted state.
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From enrolment to the end of the 16-week intervention
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Anthropometric measurements - Body weight
大体时间：From enrolment to the end of the 16-week intervention
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Body weight will be measured in kilograms before the measurements without shoes and heavy clothing.
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From enrolment to the end of the 16-week intervention
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Anthropometric measurements - length
大体时间：From enrolment to the end of the 16-week intervention
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Length will be measured in centimeters before the measurements without shoes and heavy clothing.
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From enrolment to the end of the 16-week intervention
|
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Anthropometric measurements - waist and hip circumferences
大体时间：From enrolment to the end of the 16-week intervention
|
Waist and hip circumferences will be measured in centimeters before the measurements using a SECA tape measure
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From enrolment to the end of the 16-week intervention
|
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Cognitive restrained
大体时间：From enrolment to the end of the 16-week intervention
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Cognitive restrained, disinhibition and hunger will be assessed using the Dutch three factor eating questionnaire
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From enrolment to the end of the 16-week intervention
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Disinhibition
大体时间：From enrolment tot he end of the 16-week intervention
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Cognitive restrained, disinhibition and hunger will be assessed using the Dutch three factor eating questionnaire
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From enrolment tot he end of the 16-week intervention
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Hunger
大体时间：From enrolment tot he end of the 16-week intervention
|
Cognitive restrained, disinhibition and hunger will be assessed using the Dutch three factor eating questionnaire
|
From enrolment tot he end of the 16-week intervention
|
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Quality of life assessment
大体时间：From enrolment to the end of the 16-week intervention
|
The quality of life will be assessed at the end of the interventions using a 32-item questionnaire.
This measure will quantify quality of life on different dimensions: social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life.
|
From enrolment to the end of the 16-week intervention
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Mental health
大体时间：From enrolment to the end of the 16-week intervention
|
Mental health will be assessed using the validated Beck Depression (BDI) and State-Trait Anxiety Inventories (STAI).
|
From enrolment to the end of the 16-week intervention
|
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Mood
大体时间：From enrolment to the end of the 16-week intervention
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Mood will be tested using the widely-applied Profile of Mood States (POMS).
|
From enrolment to the end of the 16-week intervention
|
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Stress
大体时间：From enrolment to the end of the 16-week intervention
|
Stress will be assessed using the Perceived Stress Scale (PSS).
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From enrolment to the end of the 16-week intervention
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Sleep characteristics
大体时间：From enrolment to the end of the 16-week intervention
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Sleep characteristics will be assessed at the end of the interventions using the Pittsburgh Sleep Quality Index (PSQI).
|
From enrolment to the end of the 16-week intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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