Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females (NCT NCT03535571)
NCT ID: NCT03535571
Last Updated: 2019-08-19
Results Overview
This questionnaire consists of a total of 30 questions that assess vitality and quality of life. The responses for these questions range from 1 to 7, where 1 indicates "never" or "not at all true" 4 indicates "sometimes" or "somewhat true" and 7 indicates "always" or "very true" depending on the item that is assessed by the question. 15 of the 30 questions are positively keyed in which a higher score indicates a better outcome and remaining 15 questions are negatively keyed where a lower score indicates a better outcome. The responses on the negatively keyed questions will be reversed prior to calculating the total score (i.e. a response of 1 will be considered as 7, 2 will be considered as 6, etc.). Total range will be 30-210, where a higher total score indicates a better outcome and a lower total score indicates a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Baseline (Day 0) to end-of-study (Day 128)
Results posted on
2019-08-19
Participant Flow
Participant milestones
| Measure |
Salmon Protein Hydrolysate (CollaGo)
Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
Baseline characteristics by cohort
| Measure |
Salmon Protein Hydrolysate (CollaGo)
n=20 Participants
Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Age, Continuous
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48.45 years
STANDARD_DEVIATION 5.79 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
African or African American
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2 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
East Asian or South East Asian
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic or Latino
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
South American
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Western or Eastern European White
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10 Participants
n=5 Participants
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Race/Ethnicity, Customized
Native American
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
This questionnaire consists of a total of 30 questions that assess vitality and quality of life. The responses for these questions range from 1 to 7, where 1 indicates "never" or "not at all true" 4 indicates "sometimes" or "somewhat true" and 7 indicates "always" or "very true" depending on the item that is assessed by the question. 15 of the 30 questions are positively keyed in which a higher score indicates a better outcome and remaining 15 questions are negatively keyed where a lower score indicates a better outcome. The responses on the negatively keyed questions will be reversed prior to calculating the total score (i.e. a response of 1 will be considered as 7, 2 will be considered as 6, etc.). Total range will be 30-210, where a higher total score indicates a better outcome and a lower total score indicates a worse outcome.
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=19 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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The Change From Baseline (Day 0) to End-of-study (Day 128) in Energy Level After a 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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13.89 score on a scale
Standard Deviation 20.49
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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0.08 cells x10^12/L
Standard Deviation 0.23
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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-1.1 fL
Standard Deviation 2.36
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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0.09 pg
Standard Deviation 0.77
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
|
|---|---|
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Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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4.65 g/L
Standard Deviation 12.9
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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0 L/L
Standard Deviation 0.02
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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-0.79 percent change in size
Standard Deviation 0.51
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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3 g/L
Standard Deviation 7.41
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
APOE
|
2.60 Fold change
Standard Deviation 0.21
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
FTH1
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3.73 Fold change
Standard Deviation 0.40
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
GCLC
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2.64 Fold change
Standard Deviation 0.35
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
GPX1
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2.96 Fold change
Standard Deviation 0.29
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
HMOX1
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4.10 Fold change
Standard Deviation 0.23
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
NQO1
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3.12 Fold change
Standard Deviation 0.17
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Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
SOD1
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3.06 Fold change
Standard Deviation 0.19
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Assessed by ROS/RNS assay
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Total Reactive Oxygen Species/Reactive Nitrogen Species Free Radical Activity After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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-0.14 mmol/L
Standard Deviation 0.11
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Measured by the Multi-Analyte ELISArray
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
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0.01 pg/mL
Standard Deviation 0.05
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Measured by the Multi-Analyte ELISArray
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
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0 pg/mL
Standard Deviation 0.03
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Measured by the Multi-Analyte ELISArray
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
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-0.07 pg/mL
Standard Deviation 0.28
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Measured by the Multi-Analyte ELISArray
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
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1.39 pg/mL
Standard Deviation 0.98
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.
Measured by the Multi-Analyte ELISArray.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Measured by the Multi-Analyte ELISArray
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
|
|---|---|
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Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
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-0.14 pg/mL
Standard Deviation 1.29
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.
Measured by the Multi-Analyte ELISArray
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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0.08 percentage of glucose bound to RBCs
Standard Deviation 0.17
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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-0.15 mmol/L
Standard Deviation 0.45
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SECONDARY outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
This questionnaire consists of a total of 7 questions that assess the participant's perception on hair (4 questions), nail (1 question) and skin health (2 question). The response to each question can range from 1 to 6 where 1 indicates "greatly satisfied" and 6 indicates "greatly dissatisfied". The range for the total score on this questionnaire is 7-42. Lower total score indicates a better outcome, and higher total score indicates a worse outcome.
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=19 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
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-0.74 score on a scale
Standard Deviation 1.22
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Frequency Threshold for Reporting Other Adverse Events: 5%. Full information can be found in the adverse events section. Summary can be found below.
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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The Incidence of Adverse Events Following a 128-day Supplementation
|
6 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Population: Intent to treat population
Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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The Effect of a 128-day Supplementation on Weight
|
0.34 kg
Standard Deviation 2.02
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
|
|---|---|
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The Effect of a 128-day Supplementation on Blood Pressure
Systolic Blood Pressure
|
4.37 mmHg
Standard Deviation 8.01
|
|
The Effect of a 128-day Supplementation on Blood Pressure
Diastolic Blood Pressure
|
0.48 mmHg
Standard Deviation 7.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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The Effect of a 128-day Supplementation on Heart Rate
|
-0.35 beats per minute
Standard Deviation 16.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
|
|---|---|
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The Effect of a 128-day Supplementation on Waist Circumference
|
0.86 cm
Standard Deviation 5.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to end-of-study (Day 128)Outcome measures
| Measure |
Salmon Protein Hydrolysate (CollaGo®)
n=20 Participants
Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
|
|---|---|
|
The Effect of a 128-day Supplementation on Hip Circumference
|
-0.48 cm
Standard Deviation 2.1
|
Adverse Events
Salmon Protein Hydrolysate (CollaGo)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Salmon Protein Hydrolysate (CollaGo)
n=20 participants at risk
Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
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Psychiatric disorders
Mental breakdown
|
5.0%
1/20 • Number of events 1 • 128-days
|
Other adverse events
| Measure |
Salmon Protein Hydrolysate (CollaGo)
n=20 participants at risk
Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.
Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.
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|---|---|
|
Musculoskeletal and connective tissue disorders
Back, muscle, leg pain
|
10.0%
2/20 • Number of events 4 • 128-days
|
|
Nervous system disorders
Neuropathy, paresthesia, tension headache
|
15.0%
3/20 • Number of events 4 • 128-days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study was conducted by a contract research organization (CRO) of which the PI is a contract employee. The agreement between the CRO and sponsor indicates that all rights to discuss and publish the trial results belong to the sponsor.
- Publication restrictions are in place
Restriction type: OTHER