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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535571
• Other study ID #: 18PEHH
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2018
• Est. completion date: October 23, 2018

Study information

• Verified date: July 2019
• Source: Hofseth Biocare ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Salmon Protein Hydrolysate
4g of salmon protein hydrolysate per serving.

Locations

Country	Name	City	State
Canada	KGK Science Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hofseth Biocare ASA	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Incidence of Adverse Events Following a 128-day Supplementation		Baseline (Day 0) to end-of-study (Day 128)
Other	The Effect of a 128-day Supplementation on Weight		Baseline (Day 0) to end-of-study (Day 128)
Other	The Effect of a 128-day Supplementation on Blood Pressure		Baseline (Day 0) to end-of-study (Day 128)
Other	The Effect of a 128-day Supplementation on Heart Rate		Baseline (Day 0) to end-of-study (Day 128)
Other	The Effect of a 128-day Supplementation on Waist Circumference		Baseline (Day 0) to end-of-study (Day 128)
Other	The Effect of a 128-day Supplementation on Hip Circumference		Baseline (Day 0) to end-of-study (Day 128)
Primary	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.	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.	Baseline (Day 0) to end-of-study (Day 128)
Secondary	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®)	Assessed by ROS/RNS assay	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray.	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	Measured by the Multi-Analyte ELISArray	Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)		Baseline (Day 0) to end-of-study (Day 128)
Secondary	Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	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.	Baseline (Day 0) to end-of-study (Day 128)