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

Nestlé

Status: Enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06598124

2314NR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Arm 1

Other group

Description:

Visit 1: Comparator Product; Visit 2: Investigational Product

Treatment:

Other: Investigational Product (IP)

Other: Comparator Product (CP)

Arm 2

Other group

Description:

Visit 1: Investigational Product; Visit 2: Comparator Product

Treatment:

Other: Investigational Product (IP)

Other: Comparator Product (CP)