Impact of Galacto-Oligosaccharides on Adult Microbiome

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Milk powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT05207839

2106NRC1

Details and patient eligibility

About

The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.