Status:
COMPLETED
Impact of Galacto-Oligosaccharides on Adult Microbiome
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.
Eligibility Criteria
Inclusion
- Age 18-55 years,
- Healthy participants, both male and female
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2
- Able to understand and to sign a written informed consent prior to study enrolment
Exclusion
- Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- Known food allergy and intolerance e.g. lactose intolerance,
- Habitually, have \< 5 spontaneous bowel movements on average per week,
- Chronic or recurrent diarrhoea with spontaneous bowel movements \> 2 per day
- Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
- Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
- Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
- Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
- Currently participating in another interventional clinical trial or research project,
- Alcohol intake \> 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
- Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
- Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
- Artificially sweetened beverage intake \>1000 ml/ per day,
- Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
- Subject having a hierarchical or family link with the research team members,
- Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05207839
Start Date
October 27 2021
End Date
December 9 2021
Last Update
May 25 2022
Active Locations (1)
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1
Clinical Innovation Lab
Lausanne, Canton of Vaud, Switzerland, 1000