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

NCT06598124 | Completed

• 1 other identifier: 2314NR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Lactose; GOS; Digestive response; Gut comfort

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Gastric emptying

  0-315 minutes after IP or CP intake

• Retention rate of gastric content volumes

  0-315 minutes after IP or CP intake

• Oro-caecal transit

  0-315 minutes after IP or CP intake

• H2 levels

  0-315 minutes after IP or CP intake

• Colonic volume

  0-315 minutes after IP or CP intake

Other Outcomes (1)

• Appetite

  0-315 minutes after IP or CP intake

Study Arms (2)

Arm 1

OTHER

Visit 1: Comparator Product; Visit 2: Investigational Product

Other: Investigational Product (IP); Other: Comparator Product (CP)

Arm 2

OTHER

Visit 1: Investigational Product; Visit 2: Comparator Product

Other: Investigational Product (IP); Other: Comparator Product (CP)

Interventions

Investigational Product (IP) OTHER

1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.

Arm 1; Arm 2

Comparator Product (CP) OTHER

1 single dose of CP consisting in 400 mL of milk with lactose

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medically diagnosed milk allergy
• Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
• Diagnosed with any gastrointestinal disorders
• History of claustrophobia
• Pregnant (defined by pregnancy test) or breast feeding
• History or current psychiatric illness
• History or current neurological condition (e.g. epilepsy)
• 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)
• Currently smoking (as declared by participant)
• Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
• Antibiotic use within the 4 weeks preceding the intervention
• Probiotic \& prebiotics use within the 2 weeks preceding the intervention

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• University of Nottingham: collaborator

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Study Officials

• Irma Silva Zolezzi

  Societé des Produits Nestlé SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single coding
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, 2x2 cross-over study

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion: April 21, 2025
• Study Completion: June 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)