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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Visit 1: Comparator Product; Visit 2: Investigational Product |
|
| Arm 2 | Other | Visit 1: Investigational Product; Visit 2: Comparator Product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Product (IP) | Other | 1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Small bowel water content | Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL*min) at 45 minutes of interval | 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 | 0-315 minutes after IP or CP intake |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | Time to empty half of the stomach contents (T1/2) (min) after product consumption assessed via MRI every 45 min | 0-315 minutes after IP or CP intake |
| Retention rate of gastric content volumes |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite | 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 | 0-315 minutes after IP or CP intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irma Silva Zolezzi | Societé des Produits Nestlé SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Nottingham | United Kingdom |
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Double-blind, randomized, 2x2 cross-over study
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Single coding
| Comparator Product (CP) | Other | 1 single dose of CP consisting in 400 mL of milk with lactose |
|
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
| 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 | 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 | 0-315 minutes after IP or CP intake |
| Colonic volume | Colonic volume measured by MRI every 45 min after product consumption (mL*min) | 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) | 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) | 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) | 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) | 0-315 minutes after IP or CP intake |
| Bristol stool | Bowel movements & stool consistency measured using a Bristol stool diary | 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) | 0-315 minutes after IP or CP intake |