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

Phase 1

Completed

Conditions: Healthy

Interventions: Dietary Supplement: Salmon Protein Hydrolysate

Registration Number: NCT03535571

Lead Sponsor: Hofseth Biocare ASA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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
Verbal confirmation of history of liver disease
Anemia based on hemoglobin and hematocrit at screening
Thyroid disease assessed case by case by QI
Iron Supplementation
Mood stabilizers assessed case by case by QI
Energy boosting supplements
Individuals on workout supplements
Habitual users of energy drinks
Melatonin supplementation assessed case by case by QI
Autoimmune disease or if immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
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.
Presence or history of neurological disorders or significant psychiatric illness as assessed by QI
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salmon Protein Hydrolysate (CollaGo®)	Salmon Protein Hydrolysate	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.

Primary Outcome Measures

Name	Time	Method
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®)	Baseline (Day 0) to end-of-study (Day 128)	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.

Secondary Outcome Measures

Name	Time	Method
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)
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)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
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)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray.
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)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
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)
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 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 Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
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®)	Baseline (Day 0) to end-of-study (Day 128)	Assessed by ROS/RNS assay
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).	Baseline (Day 0) to end-of-study (Day 128)	Measured by the Multi-Analyte ELISArray
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 Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	Baseline (Day 0) to end-of-study (Day 128)	Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.
Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)	Baseline (Day 0) to end-of-study (Day 128)	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.