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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
96
Harrison Clinical Research Clinical Unit, Hilblestrasse 54
München, Germany
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.
Time frame: 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).
Time frame: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Heart rate (bpm).
Time frame: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Weight (kg).
Time frame: 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).
Time frame: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Temperature (°C).
Time frame: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product on hematology.
Hemoglobin (mmol/L).
Time frame: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product on hematology.
Hematocrit (L/L).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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 \[watery stools\]).
Time frame: 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.
Time frame: During the 4-week period of product consumption.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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 \[watery stools\]).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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 \[watery stools\]).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: During the 4-week period of product consumption and after 4-week follow-up period.