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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
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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.
This study will focus on adults (men and postmenopausal women) aged 50 to 70 years who are overweight or moderately obese (BMI between 27 and 34.9 kg/m2) and considered metabolically healthy.
66 participants will be recruited according to the following inclusion and exclusion criteria. There will be a total of 5 visits and the study participation will last about 3.5 months.
The main hypothesis is that daily supplementation of the probiotics for 3 months in the defined population will improve certain parameters related to the cardiometabolic profile such as glucose tolerance and lipemia during the postprandial phase, compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | The product contains the probiotic strain and no other ingredients. |
|
| Placebo | Placebo Comparator | The control product is a placebo with the same characteristics of appearance and packaging as the tested product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | After randomization, participants will consume the probiotic for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Change in vital parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystèle Hogue, MSc | Contact | +1 514 223 5565 | chogue@lallemand.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA) | Recruiting | Pierre-Bénite | Auvergne-Rhône-Alpes | 69310 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | After randomization, participants will consume the placebo for 3 months. |
|
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.
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Change in blood lipid concentrations from baseline | Blood samples will be collected at each visit to report lipid concentrations such as plasma/serum triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol and non-esterified fatty acids. | 12 weeks |
| Change in blood metabolic parameters from baseline | Blood samples will be collected at each visit to report metabolic parameters such as glucose, insulin, Hba1c and ApoB. | 12 weeks |
| Change in body composition | Changes in body composition at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals to monitor progress. It is measured using multifrequency bio-impedancemetry which quantifies the total body water and the percentages of lean and fat mass. | 12 weeks |
| Change in inflammatory parameters | Changes in the plasma concentrations of TNF-α, IL6, and CRP measured at baseline and at the end of intervention, with additional measurements at 1-month and 2-month intervals for CRP. | 12 weeks |
| Change in intestinal barrier integrity biomarker | Change in the plasma concentration of Zonuline measured at baseline and at the end of intervention. | 12 weeks |
| Change in safety plasma concentration | Blood samples will be taken each visit in order to report safety plasma concentration, which includes the measurements of creatinine, GFR, urea, AST, ALT, gamma GT, bilirubin, albumin, and PAL. | 12 weeks |
| Change in fasting exhaled gases | Changes in the levels of CO2, H2, and CH4 measured at baseline and at the end of intervention. | 12 weeks |
| Change in complete blood count | Changes in the complete blood count measured throughout the intervention period. | 12 weeks |
| Change in gut microbiota | Collected stool samples will be used for microbiota analysis, which allows to assess changes in the composition and diversity of the gut microbiota throughout the intervention period, as well as probiotic strain detection. | 12 weeks |
| Change in postprandial kinetics of metabolic parameters | Changes in the maximum and minimum values during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min). | 12 weeks |
| Change in postprandial kinetics of metabolic parameters | Changes in the peak or nadir times during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min). | 12 weeks |
| Change in postprandial kinetics of metabolic parameters | Changes in the total and incremental AUCs 0-120 min, 120-300 min, and 0-300 min during the postprandial period for the following parameters: glucose (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (time t0, 30, 60, 120, 180, 240, 300 min). | 12 weeks |
| Change in postprandial kinetics of metabolic parameters | Changes in kinetics of the following parameters measured at specific time points: glucose (t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), insulin (t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 min), and total cholesterol (t0, 30, 60, 120, 180, 240, 300 min). | 12 weeks |
| Change in postprandial triglyceride levels and kinetics | Change in the maximum and minimum values as well as times at peak or nadir, total AUC 0-120 min, 120-300 min, 0-300 min during the postprandial period and triglyceride kinetics (time t0, 30, 60, 120, 180, 240, 300 min). | 12 weeks |
| Change in plasma metabolome | Change in the plasma metabolome (about 1000 metabolites from 39 different classes) measured throughout the intervention period. | 12 weeks |
| Assessment of average daily food intake | Assessing the average daily food intake of macronutrients and micronutrients using 3-day dietary surveys of the week prior to a visit. | 12 weeks |
| Change in resting energy metabolism | Change in resting energy metabolism measured by indirect calorimetry at baseline and at the end of intervention. | 12 weeks |
| Assessment of digestive tolerance | Evaluation of digestive tolerance via Gastrointestinal Symptom Assessment Scale throughout the intervention period. | 12 weeks |
| Evaluation of changes in stool assessment | Evaluation of the change in stool consistency and frequency reported via Bristol and Likert scale throughout the intervention period. | 12 weeks |
| Physical Activity Assessment | Physical activity assessed throughout the intervention period using International Physical Activity Questionnaire (IPAQ). | 12 weeks |
| Evaluation of eating behaviour | Eating behaviour and satietogenic effect will be assessed throughout the intervention period using Three-Factor Eating Questionnaire (TFEQ-R21) and Food Cravings Questionnaires (FCQ-T and FCQ-S). | 12 weeks |
| Assessment of general well-being | General well-being assessed throughout the intervention period using 36-Item Short Form Health Survey (SF-36) questionnaire. | 12 weeks |
| Assessment of stress level | General stress level assessed throughout the intervention period using Perceived Stress Scale (PSS) questionnaire. | 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |