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

NCT ID: NCT06598124

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Visit 1: Comparator Product; Visit 2: Investigational Product

Group Type: OTHER

Investigational Product (IP)

Intervention Type: OTHER

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

Comparator Product (CP)

Intervention Type: OTHER

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

Arm 2

Visit 1: Investigational Product; Visit 2: Comparator Product

Group Type: OTHER

Investigational Product (IP)

Intervention Type: OTHER

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

Comparator Product (CP)

Intervention Type: OTHER

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

Interventions

Investigational Product (IP)

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

Intervention Type: OTHER

Comparator Product (CP)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irma Silva Zolezzi

Role: STUDY_DIRECTOR

Societé des Produits Nestlé SA

Locations

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2314NR

Identifier Type: -

Identifier Source: org_study_id