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

Hofseth Biocare ASA20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Salmon Protein HydrolysateDIETARY_SUPPLEMENT

4g of salmon protein hydrolysate per serving.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

KGK Science Inc.

London, Ontario, Canada

Outcomes

Primary Outcomes

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®)

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.