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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 = Test Product normal dose | Active Comparator | Fermented dairy product containing probiotics - normal dose |
|
| 2 = Test Product high dose | Active Comparator | Fermented dairy product containing probiotics - high dose |
|
| 3 = Control Product normal dose | Sham Comparator | Non-fermented dairy product - normal dose |
|
| 4 = Control Product high dose | Sham Comparator | Non-fermented dairy product - high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented dairy product | Other |
| ||
| milk-based non-fermented dairy product |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrison Clinical Research Clinical Unit, Hilblestrasse 54 | München | D-80636 | Germany |
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| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Other |
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| 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. |
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. |
| D000074421 |
| Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |