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

NCT ID: NCT03535571

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2018-10-23

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Salmon Protein Hydrolysate (CollaGo®)

Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.

Group Type: EXPERIMENTAL

Salmon Protein Hydrolysate

Intervention Type: DIETARY_SUPPLEMENT

4g of salmon protein hydrolysate per serving.

Interventions

Salmon Protein Hydrolysate

4g of salmon protein hydrolysate per serving.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CollaGo®

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Hofseth Biocare ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18PEHH

Identifier Type: -

Identifier Source: org_study_id