Healthy
Conditions
Keywords
Lactose, GOS, Digestive response, Gut comfort
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.
Interventions
1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.
OTHERComparator Product (CP)
1 single dose of CP consisting in 400 mL of milk with lactose
Sponsors
University of Nottingham
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Single coding
Intervention model description
Double-blind, randomized, 2x2 cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut motility | 0-315 minutes after IP or CP intake | Maximum gut motility after product consumption (arbitrary unit) assessed via MRI performed every 45 min |
| Small bowel water content | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol stool | 3 days before and after after IP or CP intake | Bowel movements & stool consistency measured using a Bristol stool diary |
| Gastric emptying | 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 |
| Retention rate of gastric content volumes | 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 |
| Oro-caecal transit | 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 |
| H2 levels | 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 |
| Colonic gas production via MRI | 0-315 minutes after IP or CP intake | Colonic gas measured by MRI every 45 min after product consumption (arbitrary unit) |
| Colonic gas production via breath test | 0-315 minutes after IP or CP intake | Breath gas measurements (H2 and CH4) measured every 45 min after product consumption (ppm\*min) |
| Colonic water content | 0-315 minutes after IP or CP intake | Colonic water content measured via MRI every 45 minutes after product consumption (mL\*min) |
| GI symptoms | 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) |
| Colonic volume | 0-315 minutes after IP or CP intake | Colonic volume measured by MRI every 45 min after product consumption (mL\*min) |
| T1 relaxation time | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Appetite | 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 |
Countries
United Kingdom
Outcome results
None listed