Adults, Female, Gut Microbiota Modulation, Healthy, Male, Overweight (BMI > 25), Overweight , Obesity, Satiety and Food Intake
Conditions
Keywords
Probiotics, Overweight, Obesity, Adults, Healthy, Satiety, Food intake, Gut microbiota, Gut microbiota composition, Gut microbiota modulation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbiotic supplementation
16-week consumption of 6 g/day of probiotic supplement
OTHERPlacebo
16-week consumption of 6 g/day of placebo
Sponsors
Maastricht University Medical Center
Winclove Probiotics B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum food intake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety hormones | 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. |
| Subjective Appetite Sensation | 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. |
| Fecal microbial composition | 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. |
| Diet | 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. |
| Physical Activity | 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. |
| Insulin resistance | From enrolment to the end of the 16-week intervention | 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. |
| Blood pressure | 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). |
| Heart rate | 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). |
| Lipids | From enrolment to the end of the 16-week intervention | Fasting and postprandial serum triacylglycerol (TAG) and total cholesterol (TC) and HDL-C concentrations will be measured. |
| Inflammatory markers | From enrolment to the end of the 16-week intervention | Plasma markers related to systemic inflammation will be measured in the blood to assess low-grade systemic inflammatory responses. |
| Body Composition | From enrolment to the end of the 16-week intervention | Measurement of body composition is done by BodPod in a fasted state. |
| Anthropometric measurements - Body weight | From enrolment to the end of the 16-week intervention | Body weight will be measured in kilograms before the measurements without shoes and heavy clothing. |
| Anthropometric measurements - length | From enrolment to the end of the 16-week intervention | Length will be measured in centimeters before the measurements without shoes and heavy clothing. |
| Anthropometric measurements - waist and hip circumferences | 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 |
| Mental health | 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). |
| Mood | From enrolment to the end of the 16-week intervention | Mood will be tested using the widely-applied Profile of Mood States (POMS). |
| Stress | From enrolment to the end of the 16-week intervention | Stress will be assessed using the Perceived Stress Scale (PSS). |
| Sleep characteristics | From enrolment to the end of the 16-week intervention | Sleep characteristics will be assessed at the end of the interventions using the Pittsburgh Sleep Quality Index (PSQI). |
| Cognitive restrained | From enrolment to the end of the 16-week intervention | Cognitive restrained, disinhibition and hunger will be assessed using the Dutch three factor eating questionnaire |
| Disinhibition | 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 |
| Hunger | 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 |
| Quality of life assessment | 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. |
Countries
Netherlands
Contacts
CONTACTTanja Adam, PhD
CONTACTIris Boelen, MSc
Outcome results
None listed