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Completed

NCT Number: NCT01108419

Evaluation of Dose-effect 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harrison Clinical Research Clinical Unit, Hilblestrasse 54

München, D-80636, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fermented dairy product

Other

milk-based non-fermented dairy product

Other

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. Effect of 1 bottle/day of test versus control product vital signs.

    Time frame: During the 4-week period of product consumption.

    Weight (kg).

  5. 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).

  6. Effect of 1 bottle/day of test versus control product vital signs.

    Time frame: During the 4-week period of product consumption.

    Temperature (°C).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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)

  15. 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)

  16. 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]).

  17. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Systolic/diastolic blood pressure (mmHg).

  3. 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.

    Heart rate (bpm).

  4. 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.

    Weight (kg).

  5. 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.

    Body mass index (kg/m²).

  6. 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.

    Temperature (°C).

  7. 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.

    Hemoglobin (mmol/L).

  8. 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.

    Hematocrit (L/L).

  9. 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.

    Red blood cell, white blood cell, platelets (count/L).

  10. 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.

    blood glucose (mmol/L), lipids [total cholesterol, HDL, LDL, triglycerides] (mmol/L).

  11. 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.

    Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).

  12. 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.

    Blood creatinin (μmol/L).

  13. 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.

    Blood thyroid stimulating hormone (mU/L).

  14. 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.

    Blood C-reactive protein (mmol/L)

  15. 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.

    Fecal calprotectin (μg/g)

  16. 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.

    Stool frequency and consistency (Bristol Stool Scale from 1 [hard stools] to 7 [watery stools]).

  17. 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.

    Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.

  18. 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.

    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.

  19. 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.

    Systolic/diastolic blood pressure (mmHg).

  20. 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.

    Heart rate (bpm).

  21. 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.

    Weight (kg).

  22. 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.

    Body mass index (kg/m²).

  23. 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.

    Temperature (°C).

  24. 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.

    Hemoglobin (mmol/L).

  25. 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.

    Hematocrit (L/L).

  26. 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.

    Red blood cell, white blood cell, platelets (count/L).

  27. 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.

    blood glucose (mmol/L), lipids [total cholesterol, HDL, LDL, triglycerides] (mmol/L).

  28. 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.

    Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).

  29. 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.

    Blood creatinin (μmol/L).

  30. 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.

    Blood thyroid stimulating hormone (mU/L).

  31. 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.

    Blood C-reactive protein (mmol/L)

  32. 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.

    Fecal calprotectin (μg/g)

  33. 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.

    Stool frequency and consistency (Bristol Stool Scale from 1 [hard stools] to 7 [watery stools]).

  34. 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.

    Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.

  35. 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.

    Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces).

  36. 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.

    Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance).

  37. 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.

    Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): relative abundance of bacterial genera (%) and metabolic pathways (%).

  38. 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.

    Concentration of test product bacterial strains in feces by quantitative PCR (bacterial cells/g of feces).

  39. 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.

    Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): Alpha (index) and beta-diversity (distance).

  40. 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.

    Gut microbiota analysis by sequencing approaches (16S rRNA and shotgun sequencing): relative abundance of bacterial genera (%) and metabolic pathways (%).

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Apr 22, 2010
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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