A Study to Evaluate the Efficacy of Salmon Protein Hydrol... | NCT03535571

NCT03535571

Status Module

Sponsor/Collaborators Module

Name	Class
KGK Science Inc.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Salmon Protein Hydrolysate	Dietary Supplement	4g of salmon protein hydrolysate per serving.	Salmon Protein Hydrolysate (CollaGo®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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®)

Other Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Eligibility Criteria

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

Contacts/Locations Module

Name	Affiliation	Role
David Crowley, MD	KGK Science Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
KGK Science Inc.		London	Ontario	N6A 5R8	Canada

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 3, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	BG00020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00048.45± 5.79

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014
Male	BG0006

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

African or African American

Title	Measurements
	BG0002

East Asian or South East Asian

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Intent to treat population

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00019

Title

Denominators

Categories

Title	Measurements
	OG00013.89± 20.49

Secondary

Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

cells x10^12/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

g/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

L/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

percent change in size

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

g/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

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.

Intent to treat population

Posted

Mean

Standard Deviation

Fold change

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

mmol/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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.

This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.

Posted

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

Intent to treat population

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

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

This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.

Posted

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

percentage of glucose bound to RBCs

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Secondary

Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)

Intent to treat population

Posted

Mean

Standard Deviation

mmol/L

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

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.

Intent to treat population

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG000

Other Pre-specified

The Incidence of Adverse Events Following a 128-day Supplementation

Frequency Threshold for Reporting Other Adverse Events: 5%. Full information can be found in the adverse events section. Summary can be found below.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Other Pre-specified

The Effect of a 128-day Supplementation on Weight

Intent to treat population

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Other Pre-specified

The Effect of a 128-day Supplementation on Blood Pressure

Posted

Mean

Standard Deviation

mmHg

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Title	Denominators

Other Pre-specified

The Effect of a 128-day Supplementation on Heart Rate

Posted

Mean

Standard Deviation

beats per minute

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Title	Denominators

Other Pre-specified

The Effect of a 128-day Supplementation on Waist Circumference

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Title	Denominators

Other Pre-specified

The Effect of a 128-day Supplementation on Hip Circumference

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Salmon Protein Hydrolysate (CollaGo®)	Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.

Units	Counts
Participants	OG00020

Title	Denominators

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Salmon Protein Hydrolysate (CollaGo)	Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast. Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving.	0	20	1	20	5	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Mental breakdown	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	Determined to not be related to the study product	EG0001 events1 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Back, muscle, leg pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment		EG0004 events2 affected20 at risk
Neuropathy, paresthesia, tension headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment		EG0004 events3 affected20 at risk

Title

Denominators

Categories

Title	Measurements
	OG0000.08± 0.23

Title

Denominators

Categories

Title	Measurements
	OG000-1.1± 2.36

Title

Denominators

Categories

Title	Measurements
	OG0000.09± 0.77

Title

Denominators

Categories

Title	Measurements
	OG0004.65± 12.9

Title

Denominators

Categories

Title	Measurements
	OG0000± 0.02

Title

Denominators

Categories

Title	Measurements
	OG000-0.79± 0.51

Title

Denominators

Categories

Title	Measurements
	OG0003± 7.41

Title

Denominators

Categories

Title	Measurements
	OG0000.08± 0.17

Title

Denominators

Categories

Title	Measurements
	OG000-0.15± 0.45

Title

Denominators

Categories

Title	Measurements
	OG0006