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The primary objective of this study is to determine the tolerability of two polyglycan food ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator in this study will be Inulin FOS, a commercially available glycan supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluco-Galacto-Oligosaccharide (GOS) | Experimental | Subjects randomized to this treatment arm will ingest GOS once per day for a total of 14 days. One level of GOS will be taken during Phase I and 2 levels of GOS will be taken during Phase II. |
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| Gluco-Oligosaccharide (GLOS) | Experimental | Subjects randomized to this treatment arm will ingest GLOS once per day for a total of 14 days. One level of GLOS will be taken during Phase I and 2 levels of GLOS will be taken during Phase II. |
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| FructoOligosaccharide (FOS) | Active Comparator | Subjects randomized to this treatment arm will ingest FOS once per day for a total of 14 days. One level of FOS will be taken during Phase I and 2 levels of FOS will be taken during Phase II. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GOS | Dietary Supplement |
| ||
| GLOS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events in each group | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
Are less than 18 and greater than 40 years of age,
Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
Are hypersensitive to any of the components of the test product,
Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days,
Unwilling to avoid probiotics/prebiotics supplements for the duration of the study
Subject has taken antibiotics in the previous 3 months,
Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
Subject is a smoker,
Subject has a history of drug and/or alcohol abuse at the time of enrolment,
Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
Subjects may not be receiving treatment involving experimental drugs,
If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study,
Have a malignant disease or any concomitant end-stage organ disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials/ University Cork College | Cork | Ireland |
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| FOS | Dietary Supplement |
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