An interventional study of Fermented dairy product and milk-based non-fermented dairy product in Healthy, sponsored by Danone Global Research & Innovation Center. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Danone Global Research & Innovation Center · Not applicable, Interventional, and Other
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.
Danone Global Research & Innovation Center is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fermented dairy product containing probiotics - normal dose
Other: Fermented dairy product
Fermented dairy product containing probiotics - high dose
Other: Fermented dairy product
Non-fermented dairy product - normal dose
Other: milk-based non-fermented dairy product
Non-fermented dairy product - high dose
Other: milk-based non-fermented dairy product
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).
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.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danone Global Research & Innovation Center