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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108419

Enrollment

Registered

2010-04-22

Start date

2010-03-31

Completion date

2012-06-30

Last updated

2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy adults

Brief summary

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.

Interventions

OTHERFermented dairy product

OTHERmilk-based non-fermented dairy product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Effect of 1 bottle/day of test versus control product on adverse events.	During the 4-week period of product consumption.	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.
Effect of 1 bottle/day of test versus control product vital signs.	During the 4-week period of product consumption.	Systolic/diastolic blood pressure (mmHg).
Effect of 1 bottle/day of test versus control product on hematology.	During the 4-week period of product consumption.	Hemoglobin (mmol/L).
Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.	During the 4-week period of product consumption.	blood glucose (mmol/L), lipids \[total cholesterol, HDL, LDL, triglycerides\] (mmol/L).
Effect of 1 bottle/day of test versus control product on liver function.	During the 4-week period of product consumption.	Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).
Effect of 1 bottle/day of test versus control product on kidney function.	During the 4-week period of product consumption.	Blood creatinin (μmol/L).
Effect of 1 bottle/day of test versus control product on thyroid function.	During the 4-week period of product consumption.	Blood thyroid stimulating hormone (mU/L).
Effect of 1 bottle/day of test versus control product on blood marker of inflammation.	During the 4-week period of product consumption.	Blood C-reactive protein (mmol/L)
Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.	During the 4-week period of product consumption.	Fecal calprotectin (μg/g)
Effect of 1 bottle/day of test versus control product on bowel habits.	During the 4-week period of product consumption.	Stool frequency and consistency (Bristol Stool Scale from 1 \[hard stools\] to 7 \[watery stools\]).
Effect of 1 bottle/day of test versus control product on digestive symptoms.	During the 4-week period of product consumption.	Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.

Secondary

Measure	Time frame	Description
Effect of 1 bottle/day of test versus control product on adverse events.	During the 4-week follow-up period and the 8-week entire study period.	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.
Effect of 1 bottle/day of test versus control product vital signs.	During the 4-week follow-up period and the 8-week entire study period.	Systolic/diastolic blood pressure (mmHg).
Effect of 1 bottle/day of test versus control product on hematology.	During the 4-week follow-up period and the 8-week entire study period.	Hemoglobin (mmol/L).
Effect of 3 bottles/day of test versus control product vital signs.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Systolic/diastolic blood pressure (mmHg).
Effect of 3 bottles/day of test versus control product on test product strains detection and quantification in feces.	During the 4-week period of product consumption and after 4-week follow-up period.	Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces).
Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.	During the 4-week follow-up period and the 8-week entire study period.	blood glucose (mmol/L), lipids \[total cholesterol, HDL, LDL, triglycerides\] (mmol/L).
Effect of 1 bottle/day of test versus control product on liver function.	During the 4-week follow-up period and the 8-week entire study period.	Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).
Effect of 1 bottle/day of test versus control product on kidney function.	During the 4-week follow-up period and the 8-week entire study period.	Blood creatinin (μmol/L).
Effect of 1 bottle/day of test versus control product on thyroid function.	During the 4-week follow-up period and the 8-week entire study period.	Blood thyroid stimulating hormone (mU/L).
Effect of 1 bottle/day of test versus control product on blood marker of inflammation.	During the 4-week follow-up period and the 8-week entire study period.	Blood C-reactive protein (mmol/L)
Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.	During the 4-week follow-up period and the 8-week entire study period.	Fecal calprotectin (μg/g)
Effect of 1 bottle/day of test versus control product on bowel habits.	During the 4-week follow-up period and the 8-week entire study period.	Stool frequency and consistency (Bristol Stool Scale from 1 \[hard stools\] to 7 \[watery stools\]).
Effect of 1 bottle/day of test versus control product on digestive symptoms.	During the 4-week follow-up period and the 8-week entire study period.	Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.
Effect of 3 bottles/day of test versus control product on adverse events.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	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.
Effect of 3 bottles/day of test versus control product on hematology.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Hemoglobin (mmol/L).
Effect of 3 bottles/day of test versus control product on glucose and lipids metabolism.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	blood glucose (mmol/L), lipids \[total cholesterol, HDL, LDL, triglycerides\] (mmol/L).
Effect of 3 bottles/day of test versus control product on liver function.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).
Effect of 3 bottles/day of test versus control product on kidney function.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Blood creatinin (μmol/L).
Effect of 3 bottles/day of test versus control product on thyroid function.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Blood thyroid stimulating hormone (mU/L).
Effect of 3 bottles/day of test versus control product on blood marker of inflammation.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Blood C-reactive protein (mmol/L)
Effect of 3 bottles/day of test versus control product on fecal marker of inflammation.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Fecal calprotectin (μg/g)
Effect of 3 bottles/day of test versus control product on bowel habits.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Stool frequency and consistency (Bristol Stool Scale from 1 \[hard stools\] to 7 \[watery stools\]).
Effect of 3 bottles/day of test versus control product on digestive symptoms.	During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.	Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.
Effect of 1 bottle/day of test versus control product on test product strains detection and quantification in feces.	During the 4-week period of product consumption and after 4-week follow-up period.	Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces).
Effect of 1 bottle/day of test versus control product on microbiota analysis in feces.	During the 4-week period of product consumption and after 4-week follow-up period.	Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance).
Effect of 3 bottles/day of test versus control product on microbiota analysis in feces.	During the 4-week period of product consumption and after 4-week follow-up period.	Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026