Clinical trial NCT03535571: A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Energy increase
Energy
Healthy
anti-inflammatory
Open-label
Salmon protein
Natural health product
Dietary supplement
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2018-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: 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®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
Secondary outcomes:
measure: Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: 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®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
Other outcomes:
measure: The Incidence of Adverse Events Following a 128-day Supplementation
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: The Effect of a 128-day Supplementation on Weight
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: The Effect of a 128-day Supplementation on Blood Pressure
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: The Effect of a 128-day Supplementation on Heart Rate
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: The Effect of a 128-day Supplementation on Waist Circumference
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
measure: The Effect of a 128-day Supplementation on Hip Circumference
timeFrame: Baseline (Day 0) to end-of-study (Day 128)
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: