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Bifidobacterium strains with potential health benefits can contribute to the gastrointestinal wellbeing. However, the ability of these strains to survive gastro-intestinal tract stress and their impact on gut microbiome remains to be clarified. Moreover, prebiotic fibres, such as galacto-oligosaccharides (GOS) can promote the proliferation of Bifidobacteria. This is why the current study aims to assess the impact of Bifidobacteria consumption on human gut microbiome with or without GOS compared to control product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral administration of experimental product A | Experimental | Test product A: fermented dairy product containing Bifidobacterium strains |
|
| Oral administration of experimental product B | Experimental | Test product B: product A with galacto-oligosaccharides (GOS) |
|
| Oral administration of Control product | Placebo Comparator | Control product: commercially available yoghurt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 28-days consumption of Product A in 45 to 60-year-old healthy subjects. | Other | 48 healthy volunteers will consume Product A twice per day during 28 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species. | After 28 days of study product consumption |
| Measure | Description | Time Frame |
|---|---|---|
| The changes from baseline after 28-days product consumption in detection and quantification of viable bacteria (i.e. with intact cell membrane) for the Bifidobacterium strains. | After 28 days of study product consumption | |
| The change from baseline after 28-days product consumption of Bifidobacterium diversity indices. |
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Inclusion Criteria:
Male and female subjects aged between 45 and 60 years old.
BMI between 18.5 kg/m2 and 30 kg/m2.
Subjects who are overtly healthy as determined by the investigator.
Willing and/or able to:
Willing to limit alcohol consumption and not to smoke or consume any soft or hard drug during the study.
Having access to adequate space to store the investigational products in their own fridge at home.
Having regular bowel movements.
Signed written informed consent by the participant.
Female subjects must either be postmenopausal for at least 12 months or have undergone specific surgical procedures resulting in sterility or they are using one of the medically approved contraceptive methods.
Subject is covered by French health insurance.
Subject agrees to be registered in the national database of subjects participating in clinical research.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN | Dijon | France | ||||
| Biofortis |
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| 28-days consumption of Product B in 45 to 60-year-old healthy subjects. | Other | 48 healthy volunteers will consume Product B twice per day during 28 consecutive days. |
|
| 28-days consumption of Control product in 45 to 60-year-old healthy subjects. | Other | 48 healthy volunteers will consume Control product twice per day during 28 consecutive days. |
|
| After 28 days of study product consumption |
| Paris |
| France |
| Biofortis | Saint-Herblain | France |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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