HealthyNCT01108419
Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
A study testing Fermented dairy product and milk-based non-fermented dairy product in people with Healthy, run by Danone Global Research & Innovation Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented dairy product and milk-based non-fermented dairy product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Harrison Clinical Research Clinical Unit, Hilblestrasse 54
München, D-80636
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Fermented dairy product, milk-based non-fermented dairy product
- Keywords
- healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented dairy productOther
milk-based non-fermented dairy productOther
| Study group | Role | What they receive |
|---|---|---|
| 1 = Test Product normal dose | Active comparator | Fermented dairy product containing probiotics - normal dose Receives: Other: Fermented dairy product |
| 2 = Test Product high dose | Active comparator | Fermented dairy product containing probiotics - high dose Receives: Other: Fermented dairy product |
| 3 = Control Product normal dose | Sham comparator | Non-fermented dairy product - normal dose Receives: Other: milk-based non-fermented dairy product |
| 4 = Control Product high dose | Sham comparator | Non-fermented dairy product - high dose Receives: Other: milk-based non-fermented dairy product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Heart rate (bpm).
Measured: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Weight (kg).
Measured: 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).
Measured: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product vital signs.
Temperature (°C).
Measured: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product on hematology.
Hemoglobin (mmol/L).
Measured: During the 4-week period of product consumption.
Effect of 1 bottle/day of test versus control product on hematology.
Hematocrit (L/L).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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]).
Measured: 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.
Measured: During the 4-week period of product consumption.
Secondary outcomes (40)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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]).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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]).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: During the 4-week period of product consumption and after 4-week follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108419
- Sponsor's protocol ID
- NU327
- Status last verified
- Dec 2020
- First submitted
- 29 Mar 2010
- Last updated
- 23 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Tolerance of a New Fermented Food in Healthy Adults
- ClinicalTrials.gov ID
- NCT01108419
- Acronym / sponsor ID
- NU327
- Conditions
- Healthy
- Keywords
- healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 = Test Product normal dose | Active comparator | Other: Fermented dairy productFermented dairy product containing probiotics - normal dose |
| 2 = Test Product high dose | Active comparator | Other: Fermented dairy productFermented dairy product containing probiotics - high dose |
| 3 = Control Product normal dose | Sham comparator | Other: milk-based non-fermented dairy productNon-fermented dairy product - normal dose |
| 4 = Control Product high dose | Sham comparator | Other: milk-based non-fermented dairy productNon-fermented dairy product - high dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented dairy product | Other | 1 = Test Product normal dose, 2 = Test Product high dose |
| milk-based non-fermented dairy product | Other | 3 = Control Product normal dose, 4 = Control Product high dose |
Primary outcome
Effect of 1 bottle/day of test versus control product on adverse events.
Time frame: 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.
Time frame: During the 4-week period of product consumption.
Systolic/diastolic blood pressure (mmHg).
Effect of 1 bottle/day of test versus control product vital signs.
Time frame: During the 4-week period of product consumption.
Heart rate (bpm).
Effect of 1 bottle/day of test versus control product vital signs.
Time frame: During the 4-week period of product consumption.
Weight (kg).
Effect of 1 bottle/day of test versus control product vital signs.
Time frame: During the 4-week period of product consumption.
Body mass index (kg/m²).
Effect of 1 bottle/day of test versus control product vital signs.
Time frame: During the 4-week period of product consumption.
Temperature (°C).
Effect of 1 bottle/day of test versus control product on hematology.
Time frame: During the 4-week period of product consumption.
Hemoglobin (mmol/L).
Effect of 1 bottle/day of test versus control product on hematology.
Time frame: During the 4-week period of product consumption.
Hematocrit (L/L).
Effect of 1 bottle/day of test versus control product on hematology.
Time frame: During the 4-week period of product consumption.
Red blood cell, white blood cell, platelets (count/L).
Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the 4-week period of product consumption.
Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.
40 secondary outcomes
Effect of 1 bottle/day of test versus control product on adverse events.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: During the 4-week period of product consumption and after 4-week follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented dairy product and milk-based non-fermented dairy product in people with Healthy, run by Danone Global Research & Innovation Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 1 bottle/day of test versus control product on adverse events. (time frame: During the 4-week period of product consumption.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.