Clinical trial NCT05207839: Impact of Galacto-Oligosaccharides on Adult Microbiome
Official title: Randomized, Double-blind Trial Evaluating the Impact of the Consumption of GOS (Galacto Oligosacharides) on the Adult Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Proportion of Bifidobacteria in the stools
timeFrame: Throughout 14 days of product intake
Secondary outcomes:
measure: Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)
timeFrame: Throughout 14 days of product intake
measure: Change in Short Chain Fatty Acids (SCFA) in the plasma
timeFrame: Throughout 14 days of product intake
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Throughout 14 days of product intake
measure: Change in Short Chain Fatty Acids (SCFA) in the stool
timeFrame: Throughout 14 days of product intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab
state: Vaud
Study officials:
References: