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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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The goal of this clinical trial is to evaluate the effects of 45 days daily administration of three different doses (2.5g, 5g, and 10g) of collagen peptide in healthy adults as compared to a Placebo on intestinal permeability following an acute aspirin challenge. The main question it aims to answer is change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide, respectively as compared to a Placebo on intestinal permeability measured by the urinary lactulose : mannitol ratio (test collected over a period of 5 hours).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP GUT collagen peptides 2.5 g | Experimental | 2.5 g AP GUT collagen peptides |
|
| AP GUT collagen peptides 5 g | Experimental | 5 g AP GUT collagen peptides |
|
| AP GUT collagen peptides 10 g | Experimental | 10 g AP GUT collagen peptides |
|
| Placebo Product | Placebo Comparator | Placebo Product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP GUT collagen peptides | Dietary Supplement | AP GUT collagen peptides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide respectively as compared to a Placebo on intestinal permeability measured by the urinary lactulose : mannitol ratio (test collected over a period of 5 hours | Day 42 to Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability | Change from Day 42 to day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion | Day 42 to day 45 |
| Intestinal permeability |
| Measure | Description | Time Frame |
|---|---|---|
| Composition of the gut microbiome | To evaluate the effects of 45 days daily administration of three different doses (2.5g, 5g, and 10g) of collagen peptide in healthy adults as compared to a Placebo on Gut microbiome | Baseline to Day 45 |
| Concentration of plasma GLP-2 |
Inclusion Criteria:
Exclusion Criteria:
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
DASS-21 Depression score of >21 at screening.
Has a history of drug and/or alcohol abuse. (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); alcohol/substance abuse disorder).
Has food allergies or other issues with foods that would preclude intake of the Study Products
Lactose intolerance
Vegetarians not willing to consume animal-based food supplement.
Intolerant to aspirin.
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:
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 study.
Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Doolan | Contact | +353 21 430 7442 | adoolan@atlantiatrials.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Recruiting | Cork | Ireland | T23 R50R | Ireland |
Individual participant data will not be shared due to confidentiality, participant consent limitations, and data protection requirements.
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| Placebo | Dietary Supplement | Placebo |
|
Change from Day 42 to day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary mannitol excretion |
| Day 42 to day 45 |
| Gastrointestinal symptoms | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo as measured by Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) -Irritable Bowel Syndrome (IBS) Total score. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable. | Day 42 to Day 45 |
| Concentration of bacterial endotoxins | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Bacterial endotoxins (LPS-binding protein (LBP)) | Day 42 to Day 45 |
| Concentration of intestinal permeability markers/ tight junction dysfunction Markers | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin) | Day 42 to Day 45 |
| Concentration of an intestinal damage marker | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP)) | Day 42 to Day 45 |
| Concentration of cytokines | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10) | Day 42 to Day 45 |
| Concentration of an Inflammation marker | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Inflammation marker (Calprotectin) | Day 42 to Day 45 |
| Quality of life Physical Component Summary | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 Physical Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. | Day 42 to Day 45 |
| Quality of Life Mental Component Summary | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 Mental Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. | Day 42 to Day 45 |
| Stress | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Stress as assessed by DASS-21 - Stress scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms. | Day 42 to Day 45 |
| Anxiety | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Anxiety as assessed by DASS-21 - Anxiety scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms. | Day 42 to Day 45 |
| Intestinal permeability | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by Lactulose:Mannitol ratio | Baseline to Day 42 |
| Percentage urinary lactulose excretion | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion | Baseline to Day 42 |
| Intestinal permeability | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary mannitol excretion | Baseline to Day 42 |
| Gastrointestinal symptoms | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo as measured by Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) -Irritable Bowel Syndrome (IBS) Total score. | Baseline to Day 42 |
| Concentration of bacterial endotoxins | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Bacterial endotoxins (LPS-binding protein (LBP)) | Baseline to Day 42 |
| Concentration of intestinal permeability markers | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin) | Baseline to Day 42 |
| Concentration if intestinal damage marker | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP)) | Baseline to Day 42 |
| Concentration of Cytokines | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10) | Baseline to Day 42 |
| Concentration of an inflammation marker | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Inflammation marker (Calprotectin) | Baseline to Day 42 |
| Quality of life as assessed by SF-12- Physical Component Summary | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 PCS (Physical Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. | Baseline to Day 42 |
| Quality of life - Mental Component Summary | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 MCS (Mental Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. | Baseline to Day 42 |
| Stress | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Stress as assessed by DASS-21 - Stress scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms. | Baseline to Day 42 |
| Anxiety | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on anxiety as assessed by DASS-21 - Anxiety scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms | Baseline to Day 42 |
To evaluate the effects of 45 days daily administration of three different doses (2.5g, 5g, and 10g) of collagen peptide in healthy adults as compared to a Placebo on Plasma GLP-2 |
| Baseline to Day 45 |
| Occurrence of any Adverse Events (AEs/SAEs) |
| Baseline to Day 45 |