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

NCT03535571 | Completed Phase 1 Results

• 1 other identifier: 18PEHH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Energy increase; Energy; Healthy; anti-inflammatory; Open-label; Salmon protein; Natural health product; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (6)

• The Incidence of Adverse Events Following a 128-day Supplementation

  Baseline (Day 0) to end-of-study (Day 128)

• The Effect of a 128-day Supplementation on Weight

  Baseline (Day 0) to end-of-study (Day 128)

• The Effect of a 128-day Supplementation on Blood Pressure

  Baseline (Day 0) to end-of-study (Day 128)

Study Arms (1)

Salmon Protein Hydrolysate (CollaGo®)

EXPERIMENTAL

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

Dietary Supplement: Salmon Protein Hydrolysate

Interventions

Salmon Protein Hydrolysate DIETARY_SUPPLEMENT

4g of salmon protein hydrolysate per serving.

Also known as: CollaGo®

Salmon Protein Hydrolysate (CollaGo®)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, 30-60 years of age
• 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)
• BMI of 18.5 kg/m²-32.5 kg/m²
• Agrees to comply with study procedures
• Willing to commit to taking product for 128 days
• Agrees to provide voluntary, written, informed consent to participate in the study
• Agrees to maintain normal diet and exercise routine throughout the study
• Healthy as determined by medical history, medical physical test for good health, and laboratory results

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Blood donation during or within 30 days of the last study visit
• Taking any specific energy supplements or vitamins at least 1 month prior to and during the trial as assessed by the QI
• Unstable weight for the last 2 months prior to the study assessed case by case by QI
• Individuals on a low protein diet
• Excessive consumption of alcohol equivalent to \>2 alcoholic drinks/day
• Use of marijuana assessed case by case by QI
• Known allergy to the test material's active or inactive ingredients
• Clinically significant abnormal Physical Examination results at screening
• Participation in clinical trials in the past 30 days
• Cognitively impaired and/or unable to give informed consent
• current cardiovascular disorders or uncontrolled blood pressure will be assessed by QI)
• Verbal confirmation of history of or current diagnosis of bleeding/blood disorder
• Verbal confirmation of Type I or Type II diabetes
• Verbal confirmation of kidney disease

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Results Point of Contact

• Title: Dr. Mal Evans
• Organization: KGK Science Inc.

mevans@kgkscience.com

519-438-9374

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: June 5, 2018
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Locations

CA (1)