Evaluation of Dose-effect of a New Fermented Food in Healthy Adults

Study Overview
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Brief Summary
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The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.

Official Title
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Evaluation of the Safety and Tolerance of a New Fermented Food in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Other: Fermented dairy product
* Other: milk-based non-fermented dairy product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects after receiving a full description of the study, provide written informed consent to take part in the study. Free-living subject, as evaluated during the clinical examination. Male/female subjects aged between 18 to 55 years (bounds included). Subjects with a body mass index (BMI) between 18.5 ≤ BMI < 30kg/m². Healthy subjects (as determined by a medical examination) Exclusion Criteria: Subjects with any allergy (food, respiratory…). Subjects that have had any surgery or intervention requiring general anaesthesia in the last 4 weeks. Subjects with a history of chronic metabolic or gastrointestinal disease with the exception of appendectomy. Subjects with chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV). Subjects presenting a severe evolutive or chronic pathology (e.g. cancer,tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis, Type I diabetes…). Subject with eating disorders. Subjects with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever. Subjects with special medicated diet (for obesity, anorexia, metabolic pathology…). For female subjects: pregnancy, breast-feeding or not willing to use/not using an acceptable method of contraception Subject, in the Investigator's opinion, should not be randomised.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Test Product normal dose<br>Fermented dairy product containing probiotics - normal dose | Other: Fermented dairy product<br> <br> |
| Active Comparator: 2 = Test Product high dose<br>Fermented dairy product containing probiotics - high dose | Other: Fermented dairy product<br> <br> |
| Sham Comparator: 3 = Control Product normal dose<br>Non-fermented dairy product - normal dose | Other: milk-based non-fermented dairy product<br> <br> |
| Sham Comparator: 4 = Control Product high dose<br>Non-fermented dairy product - high dose | Other: milk-based non-fermented dairy product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of 1 bottle/day of test versus control product on adverse events. | Number of Adverse events, number of AE related to product, number of emergent AE, number of mild/moderate and severe AE, number of serious AE. | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Systolic/diastolic blood pressure (mmHg). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Heart rate (bpm). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Weight (kg). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Body mass index (kg/m²). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Temperature (°C). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Hemoglobin (mmol/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Hematocrit (L/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Red blood cell, white blood cell, platelets (count/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism. | blood glucose (mmol/L), lipids [total cholesterol, HDL, LDL, triglycerides] (mmol/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on liver function. | Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on kidney function. | Blood creatinin (μmol/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on thyroid function. | Blood thyroid stimulating hormone (mU/L). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on blood marker of inflammation. | Blood C-reactive protein (mmol/L) | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on fecal marker of inflammation. | Fecal calprotectin (μg/g) | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on bowel habits. | Stool frequency and consistency (Bristol Stool Scale from 1 [hard stools] to 7 [watery stools]). | During the 4-week period of product consumption. | 
| Effect of 1 bottle/day of test versus control product on digestive symptoms. | Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling. | During the 4-week period of product consumption. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of 1 bottle/day of test versus control product on adverse events. | Number of Adverse events, number of AE related to product, number of emergent AE, number of mild/moderate and severe AE, number of serious AE. | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Systolic/diastolic blood pressure (mmHg). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Heart rate (bpm). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Weight (kg). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Body mass index (kg/m²). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product vital signs. | Temperature (°C). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Hemoglobin (mmol/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Hematocrit (L/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on hematology. | Red blood cell, white blood cell, platelets (count/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism. | blood glucose (mmol/L), lipids [total cholesterol, HDL, LDL, triglycerides] (mmol/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on liver function. | Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on kidney function. | Blood creatinin (μmol/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on thyroid function. | Blood thyroid stimulating hormone (mU/L). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on blood marker of inflammation. | Blood C-reactive protein (mmol/L) | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on fecal marker of inflammation. | Fecal calprotectin (μg/g) | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on bowel habits. | Stool frequency and consistency (Bristol Stool Scale from 1 [hard stools] to 7 [watery stools]). | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on digestive symptoms. | Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling. | During the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on adverse events. | Number of Adverse events, number of AE related to product, number of emergent AE, number of mild/moderate and severe AE, number of serious AE. | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product vital signs. | Systolic/diastolic blood pressure (mmHg). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product vital signs. | Heart rate (bpm). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product vital signs. | Weight (kg). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product vital signs. | Body mass index (kg/m²). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product vital signs. | Temperature (°C). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on hematology. | Hemoglobin (mmol/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on hematology. | Hematocrit (L/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on hematology. | Red blood cell, white blood cell, platelets (count/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on glucose and lipids metabolism. | blood glucose (mmol/L), lipids [total cholesterol, HDL, LDL, triglycerides] (mmol/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on liver function. | Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on kidney function. | Blood creatinin (μmol/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on thyroid function. | Blood thyroid stimulating hormone (mU/L). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on blood marker of inflammation. | Blood C-reactive protein (mmol/L) | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on fecal marker of inflammation. | Fecal calprotectin (μg/g) | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on bowel habits. | Stool frequency and consistency (Bristol Stool Scale from 1 [hard stools] to 7 [watery stools]). | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 3 bottles/day of test versus control product on digestive symptoms. | Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling. | During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period. | 
| Effect of 1 bottle/day of test versus control product on test product strains detection and quantification in feces. | Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces). | During the 4-week period of product consumption and after 4-week follow-up period. | 
| Effect of 1 bottle/day of test versus control product on microbiota analysis in feces. | Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance). | During the 4-week period of product consumption and after 4-week follow-up period. | 
| Effect of 1 bottle/day of test versus control product on microbiota analysis in feces. | Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): relative abundance of bacterial genera (%) and metabolic pathways (%). | During the 4-week period of product consumption and after 4-week follow-up period. | 
| Effect of 3 bottles/day of test versus control product on test product strains detection and quantification in feces. | Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces). | During the 4-week period of product consumption and after 4-week follow-up period. | 
| Effect of 3 bottles/day of test versus control product on microbiota analysis in feces. | Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance). | During the 4-week period of product consumption and after 4-week follow-up period. | 
| Effect of 3 bottles/day of test versus control product on microbiota analysis in feces. | Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): relative abundance of bacterial genera (%) and metabolic pathways (%). | During the 4-week period of product consumption and after 4-week follow-up period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy adults