Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults (MilkRI)

Assessing the Effects of Low Lactose Milk Containing GOS (Galactooligosaccharides) on Digestive Response in Healthy Chinese Adults

We are aiming to assess the effects of low lactose milk containing galactooligosaccharides (GOS) on digestive response in healthy Chinese adults in comparison with a matching milk containing lactose.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Investigational Product (IP); Other: Comparator Product (CP)

Detailed Description

This is planned to be single-center, double-blind, randomized, 2x2 cross-over study.

24 healthy participants of Chinese ethnicity are planned to be enrolled. Participants will be invited to three visit days at the research site: a screening visit and two test days, 3 to 28 days apart.

During the test days, participants will be requested, after overnight fasting, to consume either the investigational product (IP), a skimmed milk powder with low lactose content and GOS, or the comparator product (CP) a matching skimmed milk powder, both reconstituted in water. Participants will then undergo a series of tests to compare the effects of these two drinks on gastrointestinal fluid retention and motility as well as on gut comfort.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants declare that they are of Chinese ethnicity as well as both of their biological parents
2. Women and men aged between 18 and 60 years
3. Body mass index (BMI ≥ 18.5 & <30 kg/m2)
4. Healthy: no medical conditions or previous gastrointestinal surgery which might affect study measurements (as declared by the participant)
5. Able to understand and to sign written informed consent prior to study entry
6. Informed consent signed
7. Meets all the criteria for MRI Scan
8. Can read and speak English

Exclusion Criteria:

1. Medically diagnosed milk allergy
2. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
3. Diagnosed with any gastrointestinal disorders
4. History of claustrophobia
5. Pregnant (defined by pregnancy test) or breast feeding
6. History or current psychiatric illness
7. History or current neurological condition (e.g. epilepsy)
8. Consumption of > 21 alcoholic drinks in a typical week (one serving is 0.4 dl of spirits, 1 dl of wine, or 3 dl of beer as declared by participant)
9. Currently smoking (as declared by participant)
10. Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
11. Antibiotic use within the 4 weeks preceding the intervention
12. Probiotic & prebiotics use within the 2 weeks preceding the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Visit 1: Comparator Product; Visit 2: Investigational Product	Other: Investigational Product (IP); 1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.; Other: Comparator Product (CP); 1 single dose of CP consisting in 400 mL of milk with lactose
Other: Arm 2; Visit 1: Investigational Product; Visit 2: Comparator Product	Other: Investigational Product (IP); 1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.; Other: Comparator Product (CP); 1 single dose of CP consisting in 400 mL of milk with lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small bowel water content	Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL*min) at 45 minutes of interval	0-315 minutes after investigational product (IP) or comparator product (CP) intake
Gut motility	Maximum gut motility after product consumption (arbitrary unit) assessed via MRI performed every 45 min	0-315 minutes after IP or CP intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying	Time to empty half of the stomach contents (T1/2) (min) after product consumption assessed via MRI every 45 min	0-315 minutes after IP or CP intake
Retention rate of gastric content volumes	Retention rate (RR) of gastric content volumes (GCV) calculated as the percentage of GCV in the stomach at each time point relative to the GCV measured at time 0 (%) measured via MRI every 45 min	0-315 minutes after IP or CP intake
Oro-caecal transit	Time at appearance of a food bolus in the caecum (min) measured via MRI every 54 min	0-315 minutes after IP or CP intake
H2 levels	Time at which the level of breath H2 shows a sustained (3 consecutive measurements) rise > 20ppm over baseline after product consumption (min) measured every 22 min	0-315 minutes after IP or CP intake
Colonic volume	Colonic volume measured by MRI every 45 min after product consumption (mL*min)	0-315 minutes after IP or CP intake
Colonic gas production via MRI	Colonic gas measured by MRI every 45 min after product consumption (arbitrary unit)	0-315 minutes after IP or CP intake
Colonic gas production via breath test	Breath gas measurements (H2 and CH4) measured every 45 min after product consumption (ppm*min)	0-315 minutes after IP or CP intake
Colonic water content	Colonic water content measured via MRI every 45 minutes after product consumption (mL*min)	0-315 minutes after IP or CP intake
T1 relaxation time	T1 relaxation time of ascending colon measured measured every 45 min via MRI after product consumption (ms)	0-315 minutes after IP or CP intake
Bristol stool	Bowel movements & stool consistency measured using a Bristol stool diary	3 days before and after after IP or CP intake
GI symptoms	Ordinal scoring of digestive symptoms rating via GI questionnaire composed of eight questions (score) administrated every 45 min after product consumption. Scores go from 0 to 3, 0 = not at all; 1 = mild (distinct but negligible); 2 = moderate (annoying); 3 = severe (disabling)	0-315 minutes after IP or CP intake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite	Appetite composite score calculated using answer to a VAS appetite questionnaire (4 questions) administrated every 45 min after product consumption. Scores go from 1 to 5, with higher scores meaning a worse outcome	0-315 minutes after IP or CP intake

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: University of Nottingham
• Investigators: Study Director: Irma Silva Zolezzi, Societé des Produits Nestlé SA

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): April 21, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: GOS; Lactose; Gut comfort; Digestive response
• Other Study ID Numbers: 2314NR

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