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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo.
This double-blind, placebo-controlled trial aims to assess the efficacy of collagen peptides in addressing gastrointestinal discomfort, gut microbiota composition, gut permeability, mood, anxiety, perceived stress, quality of life and cognitive function. The study will include healthy adults experiencing gastrointestinal symptoms while excluding individuals with chronic illnesses or recent infections that might impact the results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | single dose |
|
| Collagen Peptide | Active Comparator | Dissolve in water, single dose, 10 g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Peptide | Dietary Supplement | 10g Collagen Hydrolysate per sachet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo | Gastrointestinal Symptom Rating Scale (GSRS) total score (From 1-7). A higher score is a worse outcome. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of the TP on perceived GI symptoms in healthy adults compared to a placebo | GSRS dimension scores of reflux, diarrhea, abdominal pain, indigestion and constipation. Score (From 1-7). A higher score is a worse outcome. | Baseline to Week 8 |
| To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of the TP | Vital Signs : Heart rate (beats per minute) | Baseline to Week 8 |
| To assess the safety of the TP | Vital Signs: Blood pressure (mmhg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Virgilio | Rousselot BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource Site (Apex Trials) | Guelph | Ontario | N1G 0B4 | Canada |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Randomized, Double-Blind, placebo-controlled
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| Placebo |
| Other |
Placebo - active ingredients: N/A |
|
GSRS total score and dimension scores of reflux, diarrhea, abdominal pain, indigestion and constipation. Score (From 1-7). A higher score is a worse outcome. |
| Baseline to Week 4 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bifidobacteriaceae (B. longum) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bifidobacteriaceae (B. bifidum) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Pevotellaceae (P. copri) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Pevotellaceae (P. Stercorea) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bacteroides (B. Cellulosilyticus) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bacteroides (B. thetaiotaomicron) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bacteroides (B. intestinalis) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bacteroides (B. caecimuris) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Bacteroides (B. fragilis) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Lactobacillaceae (L. salivarus) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Lactobacillaceae (L. paracasei) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Ruminococccaceae (F. prausnitzii) in the stool sample as assessed by qPCR | Baseline to Week 8 |
| To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo | Change in the abundance of Lachnospiraceae (R. hominis) in the stool sample as assessed by qPCR. | Baseline To Week 8 |
| To assess the effect of the TP on mood/anxiety in healthy adults compared to a placebo | Change in Brunnel Mood Scale questionnaire scores or anger, confusion, depression, fatigue, tension and vigour. The Scale is from 0-16, a higher score is worse. | Baseline to Week 8 |
| To assess the effect of the TP on perceived stress in healthy adults compared to a placebo | Change in Perceived Stress Scale -10 score - The score is from 0-40, a higher score is worse. | Baseline to Week 8 |
| To assess the effect of the TP on quality of life in healthy adults compared to a placebo | Change in Research and Development Short Form - 36 score. The score is from 0-100, a higher score is better. | Baseline to Week 8 |
| To assess the effect of the TP on cognitive function in healthy adults compared to a placebo | Change from baseline to Week 8 in Trail Making Test score. Time is recorded in seconds to complete the test, a higher time is worse. | Baseline to Week 8 |
| To assess the effect of the TP on cognitive function in healthy adults compared to a placebo | Change in Dimensional Change Card Sort Test score of executive function. The score is from 0-12, a higher score is better.. | Week 8 |
| To assess the effect of the TP on cognitive function in healthy adults compared to a placebo | Change in Flanker Inhibitory Control and Attention Test score of executive function. The test measures time in milliseconds, a higher time is worse. | Baseline to Week 8 |
| To assess the effect of the TP on cognitive function in healthy adults compared to a placebo | Change in Stroop Colour and Word Test score of executive function. The test measures time in milliseconds, a higher time is worse. | Baseline to Week 8 |
| To assess the effect of the TP on intestinal permeability in healthy adults compared to a placebo | Change in serum LPS levels | Baseline to Week 8 |
| Baseline to Week 8 |
| To assess the safety of the TP | Anthropometrics: Weight (kilograms) | Baseline to Week 8 |
| To assess the safety of the TP | Anthropometrics: BMI (Body Mass Index) in body weight (kilograms) divided by the square of their height (meters) | Baseline to Week 8 |
| To assess the safety of the TP | Report Adverse Events | Baseline to Week 8 |