Impact of Galacto-Oligosaccharides on Adult Microbiome

NCT ID: NCT05207839

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2021-12-09

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Milk powder without GOS

Group Type: PLACEBO_COMPARATOR

Milk powder

Intervention Type: DIETARY_SUPPLEMENT

one sachet per day dissolved in 200 ml of water

Milk powder with GOS

Group Type: ACTIVE_COMPARATOR

Milk powder

Intervention Type: DIETARY_SUPPLEMENT

one sachet per day dissolved in 200 ml of water

Interventions

Milk powder

one sachet per day dissolved in 200 ml of water

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Innovation Lab

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Siegwald L, Cherta-Murillo A, Christen S, Boulange CL, Chou CJ, Foata F, Lahiry A, Frezal A, Giner MP, Godin JP, Sakwinska O. The Impact of Low-Lactose, High Galacto-Oligosaccharides Milk on Gut Microbiome and Plasma Metabolome in Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial Complemented by Ex Vivo Experiments. Curr Dev Nutr. 2025 Jul 24;9(9):107506. doi: 10.1016/j.cdnut.2025.107506. eCollection 2025 Sep.

Reference Type: DERIVED

PMID: 40909168 (View on PubMed)

Other Identifiers

2106NRC1

Identifier Type: -

Identifier Source: org_study_id