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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.
1 single dose of CP consisting in 400 mL of milk with lactose
University of Nottingham
Nottingham, United Kingdom
Small bowel water content
Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL\*min) at 45 minutes of interval
Time frame: 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
Time frame: 0-315 minutes after IP or CP intake
Gastric emptying
Time to empty half of the stomach contents (T1/2) (min) after product consumption assessed via MRI every 45 min
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0-315 minutes after IP or CP intake
Colonic volume
Colonic volume measured by MRI every 45 min after product consumption (mL\*min)
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Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 0-315 minutes after IP or CP intake
Bristol stool
Bowel movements \& stool consistency measured using a Bristol stool diary
Time frame: 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)
Time frame: 0-315 minutes after IP or CP intake