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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Fermented dairy product; Other: milk-based non-fermented dairy product

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • München, Germany, D-80636
    • Harrison Clinical Research Clinical Unit, Hilblestrasse 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Danone Research

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 29, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: healthy adults
• Other Study ID Numbers: NU327