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

NCT07616752 | Completed

• 1 other identifier: SPH001-19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight (BMI > 25); Weight Loss

Keywords

Body mass index; Overweight; Salmon protein hydrolysate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in Body mass index (BMI)

  Baseline (week 0), week 8

• Percentage change in body composition compartments

  Baseline (week 0), week 8

• Change in glycated hemoglobin (HbA1c %)

  Baseline (week 0), week 8

• Change in fasting plasma glucose (mg/dL)

  Baseline (week 0), week 8

• Change in Inflammatory biomarkers

  Baseline (week 0), week 8

Study Arms (2)

12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks)

EXPERIMENTAL

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

12g per day of whey protein isolate (WPI) for 56 days (8-weeks)

ACTIVE COMPARATOR

Other: Nutritional Supplement

Interventions

Nutritional supplementation OTHER

ProGo is a proprietary mix of bioactive peptides.

Also known as: ProGo

12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks)

Nutritional Supplement OTHER

Standard whey protein

12g per day of whey protein isolate (WPI) for 56 days (8-weeks)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead

Study Sites (1)

Spectrum Clinical Research

Mumbai, Maharashtra, 400020, India

Location

MeSH Terms

Conditions

Overweight; Weight Loss

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Freddy Halvadar, PhD

  GPH Biotech LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start: July 19, 2019
• Primary Completion: November 3, 2019
• Study Completion: January 3, 2020
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)