Health TrialsbyHealthPanel

EXploratory Study on Postprandial Energy Metabolism

ConditionsObesity and OverweightModerately Obese
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    After randomization, participants will consume the probiotic for 3 months.

  • Placebo

    Dietary supplement

    After randomization, participants will consume the placebo for 3 months.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in postprandial triglyceridemia after 3 months

The difference (delta) from baseline in the area under the incremental curve (AUCi (0-300 min)) of postprandial triglyceridemia in response to a test meal after 12 weeks of probiotic supplementation versus placebo.

Time frame
12 weeks

Secondary outcomes

1

Change in vital parameter

Changes in pulse measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.

Time frame
12 weeks
2

Change in vital parameter

Change in blood pressure measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.

Time frame
12 weeks
3

Change in anthropometric measurement

BMI calculated in kg/m\^2 by measuring the weight and height at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.

Time frame
12 weeks
4

Change in anthropometric measurement

Waist-to-hip ratio calculated by measuring the waist and hip circumference at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lallemand Health Solutions

Lead sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Collaborator

Source ClinicalTrials.gov
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