Impact of Galacto-Oligosaccharides on Adult Microbiome

Randomized, Double-blind Trial Evaluating the Impact of the Consumption of GOS (Galacto Oligosacharides) on the Adult Microbiome

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Milk powder

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Clinical Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Milk powder without GOS	Dietary supplement: Milk powder; one sachet per day dissolved in 200 ml of water
Active Comparator: Milk powder with GOS	Dietary supplement: Milk powder; one sachet per day dissolved in 200 ml of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Bifidobacteria in the stools	Measured by Next Generation Sequencing (NGS)	Throughout 14 days of product intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status).	Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the plasma	The SFCA are measured in the plasma using Liquid Chromatography with tandem mass spectrometry (LC-MSMS)	Throughout 14 days of product intake
Gastrointestinal Symptom Rating Scale (GSRS)	Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.	Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool	Measured using Gas Chromatography (GC)	Throughout 14 days of product intake

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2106NRC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No