Clinical trial NCT06598124: Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults
Official title: Assessing the Effects of Low Lactose Milk Containing GOS (Galactooligosaccharides) on Digestive Response in Healthy Chinese Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Lactose
GOS
Digestive response
Gut comfort
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University of Nottingham
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomized, 2x2 cross-over study
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Small bowel water content
timeFrame: 0-315 minutes after investigational product (IP) or comparator product (CP) intake
measure: Gut motility
timeFrame: 0-315 minutes after IP or CP intake
Secondary outcomes:
measure: Gastric emptying
timeFrame: 0-315 minutes after IP or CP intake
measure: Retention rate of gastric content volumes
timeFrame: 0-315 minutes after IP or CP intake
measure: Oro-caecal transit
timeFrame: 0-315 minutes after IP or CP intake
measure: H2 levels
timeFrame: 0-315 minutes after IP or CP intake
measure: Colonic volume
timeFrame: 0-315 minutes after IP or CP intake
measure: Colonic gas production via MRI
timeFrame: 0-315 minutes after IP or CP intake
measure: Colonic gas production via breath test
timeFrame: 0-315 minutes after IP or CP intake
measure: Colonic water content
timeFrame: 0-315 minutes after IP or CP intake
measure: T1 relaxation time
timeFrame: 0-315 minutes after IP or CP intake
measure: Bristol stool
timeFrame: 3 days before and after after IP or CP intake
measure: GI symptoms
timeFrame: 0-315 minutes after IP or CP intake
Other outcomes:
measure: Appetite
timeFrame: 0-315 minutes after IP or CP intake
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Societé des Produits Nestlé SA
name: Irma Silva Zolezzi
role: STUDY_DIRECTOR
References: