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.
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
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
Parallel
Probiotic supplementation
Dietary supplement16-week consumption of 6 g/day of probiotic supplement
Placebo
Other intervention16-week consumption of 6 g/day of placebo
Ad libitum food intake
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.
Satiety hormones
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
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
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
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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Maastricht University Medical Center
Lead sponsor
Winclove Probiotics B.V.
Collaborator
