Obesity, metabolic disease, food intake regulation, gut dysbiosis Obesity, food intake regulation
Conditions
Interventions
Study participants will receive a 
daily dose of 
6 g of a newly composed probiotic supplement (packed in sachets of 3 g) 
or placebo for 16 weeks.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men en women aged between 20-70 yearsBMI at least 25 or higher (weight/ (length x length))Fasting plasma glucose < 7.0mmol/LStable 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 studyNo difficult venipuncture as evidenced during the screening visit
Exclusion criteria
Exclusion criteria: Diabetic patients (type 1 and type 2)Abuse of drugsMore than 2 units alcoholic consumptions per day for women and 3 for menUse 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 investigatorsGastrointestinal disease (including IBD and IBS) Use of an investigational product within another biomedical intervention trial within the previous 1-monthSevere 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 arthritisActive cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accidentuse of lipid- and glucose lowering medication, corticosteroid usePsychiatric diagnoses including clinical depressionIntolerances or dietary habits that might interfere with the study (i.e. lactose intolerance or veganism)pregnancysmoking, vapinguse of antibiotics up to 3 months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are related to changes in satiety hormones (including GLP-1), perceived satiety, faecal microbiota analysis, insulin sensitivity (HOMA-IR), and lipid metabolism | — |
Countries
Netherlands
Contacts
Public ContactTCM Adam
Universiteit Maastricht
Outcome results
None listed