A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
Condition: Healthy
Intervention: Salmon Protein Hydrolysate
Intervention description: 4g of salmon protein hydrolysate per serving.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Energy increase; Energy; Healthy; anti-inflammatory; Open-label; Salmon protein; Natural health product; Dietary supplement

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