Impact of Galacto-Oligosaccharides on Adult Microbiome

NCT05207839 | Completed

• 1 other identifier: 2106NRC1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Bifidobacteria in the stools

  Measured by Next Generation Sequencing (NGS)

  Throughout 14 days of product intake

Secondary Outcomes (4)

• Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)

  Throughout 14 days of product intake

• Change in Short Chain Fatty Acids (SCFA) in the plasma

  Throughout 14 days of product intake

• Gastrointestinal Symptom Rating Scale (GSRS)

  Throughout 14 days of product intake

• Change in Short Chain Fatty Acids (SCFA) in the stool

  Throughout 14 days of product intake

Study Arms (2)

Milk powder without GOS

PLACEBO COMPARATOR

Dietary Supplement: Milk powder

Milk powder with GOS

ACTIVE COMPARATOR

Dietary Supplement: Milk powder

Interventions

Milk powder DIETARY_SUPPLEMENT

one sachet per day dissolved in 200 ml of water

Milk powder with GOS; Milk powder without GOS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40909168 DERIVED

MeSH Terms

Interventions

Refit milk powder

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: January 26, 2022
• Study Start: October 27, 2021
• Primary Completion: December 8, 2021
• Study Completion: December 9, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)