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Completed

NCT Number: NCT06598124

Effects of Low Lactose Milk Containing GOS 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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Gastric emptying

    Time frame: 0-315 minutes after IP or CP intake

    Time to empty half of the stomach contents (T1/2) (min) after product consumption assessed via MRI every 45 min

  2. Retention rate of gastric content volumes

    Time frame: 0-315 minutes after IP or CP intake

    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

  3. Oro-caecal transit

    Time frame: 0-315 minutes after IP or CP intake

    Time at appearance of a food bolus in the caecum (min) measured via MRI every 54 min

  4. H2 levels

    Time frame: 0-315 minutes after IP or CP intake

    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

  5. Colonic volume

    Time frame: 0-315 minutes after IP or CP intake

    Colonic volume measured by MRI every 45 min after product consumption (mL*min)

  6. Colonic gas production via MRI

    Time frame: 0-315 minutes after IP or CP intake

    Colonic gas measured by MRI every 45 min after product consumption (arbitrary unit)

  7. Colonic gas production via breath test

    Time frame: 0-315 minutes after IP or CP intake

    Breath gas measurements (H2 and CH4) measured every 45 min after product consumption (ppm*min)

  8. Colonic water content

    Time frame: 0-315 minutes after IP or CP intake

    Colonic water content measured via MRI every 45 minutes after product consumption (mL*min)

  9. T1 relaxation time

    Time frame: 0-315 minutes after IP or CP intake

    T1 relaxation time of ascending colon measured measured every 45 min via MRI after product consumption (ms)

  10. Bristol stool

    Time frame: 3 days before and after after IP or CP intake

    Bowel movements & stool consistency measured using a Bristol stool diary

  11. GI symptoms

    Time frame: 0-315 minutes after IP or CP intake

    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)

Other outcomes

  1. Appetite

    Time frame: 0-315 minutes after IP or CP intake

    Appetite composite score calculated using answer to a VAS appetite questionnaire (4 questions) administrated every 45 min after product consumption. Scores go from 1 to 5, with higher scores meaning a worse outcome

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • University of Nottingham

Registry information

Official study title

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

Acronym: MilkRI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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