A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females

• ClinicalTrials.gov Identifier: NCT03535571
• Recruitment Status: Completed
• First Posted: May 24, 2018
• Results First Posted: August 19, 2019
• Last Update Posted: August 19, 2019
• Sponsor: Hofseth Biocare ASA
• Collaborator: KGK Science Inc.
• Information provided by (Responsible Party): Hofseth Biocare ASA

Study Description

Brief Summary:

The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females. Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a study diary. Assessments will be measured at the randomization visit, and the end of study visit.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Salmon Protein Hydrolysate	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Proof-of-concept Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
• Actual Study Start Date: June 5, 2018
• Actual Primary Completion Date: October 23, 2018
• Actual Study Completion Date: October 23, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Salmon Protein Hydrolysate (CollaGo®); Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.	Dietary Supplement: Salmon Protein Hydrolysate; 4g of salmon protein hydrolysate per serving.; Other Name: CollaGo®

Outcome Measures

Primary Outcome Measures :

1. 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®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]

   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.

Secondary Outcome Measures :

1. Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
2. Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
3. Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
4. Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
5. Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
6. Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
7. Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
8. Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
   Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.
9. 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®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
   Assessed by ROS/RNS assay
10. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
11. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
12. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
13. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
14. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray.
15. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®). [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
16. Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
    Measured by the Multi-Analyte ELISArray
17. Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
18. Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
19. Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]

    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.

Other Outcome Measures:

1. The Incidence of Adverse Events Following a 128-day Supplementation [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
2. The Effect of a 128-day Supplementation on Weight [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
3. The Effect of a 128-day Supplementation on Blood Pressure [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
4. The Effect of a 128-day Supplementation on Heart Rate [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
5. The Effect of a 128-day Supplementation on Waist Circumference [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]
6. The Effect of a 128-day Supplementation on Hip Circumference [ Time Frame: Baseline (Day 0) to end-of-study (Day 128) ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Healthy male or female, 30-60 years of age

2. Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,

   Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner (shown successful as per appropriate follow-up)
3. BMI of 18.5 kg/m²-32.5 kg/m²
4. Agrees to comply with study procedures
5. Willing to commit to taking product for 128 days
6. Agrees to provide voluntary, written, informed consent to participate in the study
7. Agrees to maintain normal diet and exercise routine throughout the study
8. Healthy as determined by medical history, medical physical test for good health, and laboratory results

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
2. Blood donation during or within 30 days of the last study visit
3. Taking any specific energy supplements or vitamins at least 1 month prior to and during the trial as assessed by the QI
4. Unstable weight for the last 2 months prior to the study assessed case by case by QI
5. Individuals on a low protein diet
6. Excessive consumption of alcohol equivalent to >2 alcoholic drinks/day
7. Use of marijuana assessed case by case by QI
8. Known allergy to the test material's active or inactive ingredients
9. Clinically significant abnormal Physical Examination results at screening
10. Participation in clinical trials in the past 30 days
11. Cognitively impaired and/or unable to give informed consent
12. current cardiovascular disorders or uncontrolled blood pressure will be assessed by QI)
13. Verbal confirmation of history of or current diagnosis of bleeding/blood disorder
14. Verbal confirmation of Type I or Type II diabetes
15. Verbal confirmation of kidney disease
16. Verbal confirmation of history of liver disease
17. Anemia based on hemoglobin and hematocrit at screening
18. Thyroid disease assessed case by case by QI
19. Iron Supplementation
20. Mood stabilizers assessed case by case by QI
21. Energy boosting supplements
22. Individuals on workout supplements
23. Habitual users of energy drinks
24. Melatonin supplementation assessed case by case by QI
25. Autoimmune disease or if immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
26. Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
27. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission will be assessed by the QI for inclusion.
28. Presence or history of neurological disorders or significant psychiatric illness as assessed by QI
29. Any other condition, in the QI's opinion, which may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant

Contacts and Locations

Locations

Canada, Ontario

KGK Science Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

Hofseth Biocare ASA

KGK Science Inc.

Investigators

• Principal Investigator: David Crowley, MD; KGK Science Inc.

  Study Documents (Full-Text)

Documents provided by Hofseth Biocare ASA:

Study Protocol and Statistical Analysis Plan  [PDF] May 3, 2018

More Information

• Responsible Party: Hofseth Biocare ASA
• ClinicalTrials.gov Identifier: NCT03535571
• Other Study ID Numbers: 18PEHH
• First Posted: May 24, 2018
• Results First Posted: August 19, 2019
• Last Update Posted: August 19, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hofseth Biocare ASA:

Energy increase; Energy; Healthy; anti-inflammatory; Open-label; Salmon protein; Natural health product; Dietary supplement