EXploratory Study on Postprandial Energy Metabolism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-70
SponsorLallemand Health Solutions
About this trial
This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.
Eligibility criteria
Qualifiers
Man or woman;
Age between 50 and 70 years old (inclusively);
Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
BMI between 27 and 34.9 kg/m2 (inclusively);
Disqualifiers
Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be non-compliant or uncooperative during the study or that could compromise the safety or participation in the study (according to articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code);
Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
Tobacco consumption (or vaping equivalent) > to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided for in the protocol;
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lallemand Health Solutions
Lead sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborator
Source ClinicalTrials.gov