HealthyMilkRINCT06598124
Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults
A study testing Investigational Product (IP) and Comparator Product (CP) in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Investigational Product (IP) and Comparator Product (CP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Investigational Product (IP), Comparator Product (CP)
- Keywords
- Lactose, GOS, Digestive response, Gut comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product (IP)Other
1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.
Comparator Product (CP)Other
1 single dose of CP consisting in 400 mL of milk with lactose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Visit 1: Comparator Product; Visit 2: Investigational Product Receives: Other: Investigational Product (IP); Other: Comparator Product (CP) |
| Arm 2 | Other | Visit 1: Investigational Product; Visit 2: Comparator Product Receives: Other: Investigational Product (IP); Other: Comparator Product (CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel water content
Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL*min) at 45 minutes of interval
Measured: 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
Measured: 0-315 minutes after IP or CP intake
Secondary outcomes (11)
Gastric emptying
Time to empty half of the stomach contents (T1/2) (min) after product consumption assessed via MRI every 45 min
Measured: 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
Measured: 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
Measured: 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
Measured: 0-315 minutes after IP or CP intake
Colonic volume
Colonic volume measured by MRI every 45 min after product consumption (mL*min)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 0-315 minutes after IP or CP intake
Bristol stool
Bowel movements \& stool consistency measured using a Bristol stool diary
Measured: 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)
Measured: 0-315 minutes after IP or CP intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Aug 2024
- Primary completion21 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, 2x2 cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Irma Silva Zolezzi, Study director, Societé des Produits Nestlé SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598124
- Sponsor's protocol ID
- 2314NR
- Acronym
- MilkRI
- Status last verified
- Nov 2025
- First submitted
- 15 Aug 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Low Lactose Milk Containing GOS (Galactooligosaccharides) on Digestive Response in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT06598124
- Acronym / sponsor ID
- MilkRI / 2314NR
- Conditions
- Healthy
- Keywords
- Lactose, GOS, Digestive response, Gut comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, 2x2 cross-over study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Investigational Product (IP), Other: Comparator Product (CP)Visit 1: Comparator Product; Visit 2: Investigational Product |
| Arm 2 | Other | Other: Investigational Product (IP), Other: Comparator Product (CP)Visit 1: Investigational Product; Visit 2: Comparator Product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Product (IP)1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS. | Other | Arm 1, Arm 2 |
| Comparator Product (CP)1 single dose of CP consisting in 400 mL of milk with lactose | Other | Arm 1, Arm 2 |
Primary outcome
Small bowel water content
Time frame: 0-315 minutes after investigational product (IP) or comparator product (CP) intake
Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL*min) at 45 minutes of interval
Gut motility
Time frame: 0-315 minutes after IP or CP intake
Maximum gut motility after product consumption (arbitrary unit) assessed via MRI performed every 45 min
11 secondary outcomes
Gastric emptying
Time frame: 0-315 minutes after IP or CP intake
Retention rate of gastric content volumes
Time frame: 0-315 minutes after IP or CP intake
Oro-caecal transit
Time frame: 0-315 minutes after IP or CP intake
H2 levels
Time frame: 0-315 minutes after IP or CP intake
Colonic volume
Time frame: 0-315 minutes after IP or CP intake
Colonic gas production via MRI
Time frame: 0-315 minutes after IP or CP intake
Colonic gas production via breath test
Time frame: 0-315 minutes after IP or CP intake
Colonic water content
Time frame: 0-315 minutes after IP or CP intake
T1 relaxation time
Time frame: 0-315 minutes after IP or CP intake
Bristol stool
Time frame: 3 days before and after after IP or CP intake
GI symptoms
Time frame: 0-315 minutes after IP or CP intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma Silva Zolezzi study director
Societé des Produits Nestlé SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Product (IP) and Comparator Product (CP) in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel water content (time frame: 0-315 minutes after investigational product (IP) or comparator product (CP) intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.