The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health

A Randomized, Placebo-controlled, Double Blind Study to Evaluate the Impact of ProGo® Supplementation on Hematologic and Metabolic Health Markers in Healthy Adults

Healthy, overweight males and females randomised to receive 8-weeks of salmon protein hydrolysate SPH (12g daily) or whey protein isolate (12g daily) to assess the impact on red blood cell and ferritin levels, blood glucose levels, BMI, percent body fat and lean body mass along with hair, skin and nail health and blood biomarkers of inflammation.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Overweight (BMI > 25)
• Intervention / Treatment: Other: Nutritional supplementation; Other: Nutritional Supplement

Detailed Description

This randomised, double-blinded study assessed the impact of 8-weeks of salmon protein hydrolysate SPH (12g daily) or whey protein isolate (12g daily) on important biomarkers of health and longevity. Changes in complete blood count and ferritin will assess improvements in iron metabolism and change in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) glucose metabolism assessed via blood draw. Change in hair, nail and skin quality assessed by questionnaire and change in body profile assessments by bioelectrical impedance analysis (BIA) to assess change in body fat, lean mass and body water along with measurements of hip and waist circumference. Inflammatory biomarkers assessed via blood draw along with fasting gherlin (impact on appetite) and zonulin (gut health / leaky gut biomarker).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400020
      • Spectrum Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects that have provided written and dated informed consent.
• Subjects that are in good health as determined by self-declared medical history and physical examination.
• Subjects that are male or female between the ages of 25 and 65 (inclusive).
• Subjects that have a Body Mass Index of 25-35.
• Subjects that are willing and able to comply with the supplement protocol.
• Subject who is willing and able to comply with the supplement intake regimen, lab visits schedule and weekly telephone follow up calls .

Exclusion Criteria:

• Subjects that currently hyper exercise defined as 3 hours or more for more than five times per week.
• Subjects that have used weight loss medications within the past one month of the Screening visit.
• Subjects that self-declare a known previous diagnosis of alcohol or substance abuse or have electrolyte abnormalities, thyroid, diabetes, hypogonadism, hepato-renal, musculoskeletal, autoimmune, neurologic, psychiatric disorders, or cancer which are under active drug treatment.
• Subjects who self-declare to having a peptic ulcer or active IBS under daily prescription drug treatment.
• Subjects who are self-declared to be pregnant, trying to become pregnant, or who are nursing or who are less than 6 months postpartum at enrollment.
• Subject that has been hospitalized within the past one-year for any mental or emotional illness.
• Subjects who have an active infection or sign/symptoms of an infection.
• Subjects who have a known allergy to any of the ingredients in any of the test products.
• Subjects that have a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks); SPH is a highly soluble mix of small peptides derived from Norwegian Atlantic salmon via a proprietary enzymatic hydrolysis process using natural, non-GMO protease enzymes	Other: Nutritional supplementation; ProGo is a proprietary mix of bioactive peptides.; Other Names: ProGo
Active Comparator: 12g per day of whey protein isolate (WPI) for 56 days (8-weeks)	Other: Nutritional Supplement; Standard whey protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin (g/L)	Change in serum hemoglobin level (g/L) from baseline to week 8	Baseline (week 0), week 8
Change in serum ferritin (mg/L)	Change in serum ferritin (micrograms/L) from baseline to end of study	Baseline (week 0), week 8
Integumentary outcomes	Change in perceived hair, nail and skin quality assessed by self-assessment questionnaire consisting of seven items evaluating hair volume, hair softness, hair shine, hair strength, nail strength, skin hydration, and overall skin health administered at baseline and on day 56. Each item is rated on a 6-point Likert scale ranging from 1 ("greatly satisfied") to 6 ("greatly dissatisfied"), with lower scores indicating more favorable outcomes.	8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body mass index (BMI)	Change in BMI (%) from baseline to end of study	Baseline (week 0), week 8
Percentage change in body composition compartments	Body composition assessed using the InBody 570, a multi-frequency bioelectrical impedance analysis (BIA) device (InBody, Cerritos, CA, USA), providing a calculation of percentage of body fat, percentage of lean body mass and percentage of body water.	Baseline (week 0), week 8
Change in glycated hemoglobin (HbA1c %)	Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study	Baseline (week 0), week 8
Change in fasting plasma glucose (mg/dL)	Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study	Baseline (week 0), week 8
Change in Inflammatory biomarkers	Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study	Baseline (week 0), week 8
Change in zonulin and gherlin	Assessment of change in markers of leaky gut and appetite from baseline to end of study	Baseline (week 0), week 8

Collaborators and Investigators

• Sponsor: Hofseth Biocare ASA
• Investigators: Principal Investigator: Freddy Halvadar, PhD, GPH Biotech LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): November 3, 2019
• Study Completion (Actual): January 3, 2020

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Overweight; Body mass index; Salmon protein hydrolysate
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Weight Loss; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: SPH001-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Protection participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No