Overweight (BMI > 25)NCT07616752
The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health
A study testing Nutritional supplementation and Nutritional Supplement in people with Overweight (BMI > 25) and Weight Loss, run by Hofseth Biocare ASA at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25), Weight Loss
- What is being tested?
- Nutritional supplementation and Nutritional Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jul 2019to 3 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Overweight (BMI > 25), Weight Loss
- Being tested
- Nutritional supplementation, Nutritional Supplement
- Keywords
- Body mass index, Overweight, Salmon protein hydrolysate
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementationOther
Also called ProGo
ProGo is a proprietary mix of bioactive peptides.
Nutritional SupplementOther
Standard whey protein
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nutritional supplementation |
| 12g per day of whey protein isolate (WPI) for 56 days (8-weeks) | Active comparator | Not described Receives: Other: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (g/L)
Change in serum hemoglobin level (g/L) from baseline to week 8
Measured: Baseline (week 0), week 8
Change in serum ferritin (mg/L)
Change in serum ferritin (micrograms/L) from baseline to end of study
Measured: 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.
Measured: 8-weeks
Secondary outcomes (6)
Change in Body mass index (BMI)
Change in BMI (%) from baseline to end of study
Measured: 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.
Measured: Baseline (week 0), week 8
Change in glycated hemoglobin (HbA1c %)
Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (week 0), week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start19 Jul 2019
- Primary completion3 Nov 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Freddy Halvadar, PhD, Principal investigator, GPH Biotech LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616752
- Sponsor's protocol ID
- SPH001-19
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protection participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double Blind Study to Evaluate the Impact of ProGo® Supplementation on Hematologic and Metabolic Health Markers in Healthy Adults
- ClinicalTrials.gov ID
- NCT07616752
- Acronym / sponsor ID
- SPH001-19
- Conditions
- Overweight (BMI > 25), Weight Loss
- Keywords
- Body mass index, Overweight, Salmon protein hydrolysate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks) | Experimental | Other: Nutritional supplementationSPH 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 |
| 12g per day of whey protein isolate (WPI) for 56 days (8-weeks) | Active comparator | Other: Nutritional Supplement |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementationAlso: ProGoProGo is a proprietary mix of bioactive peptides. | Other | 12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks) |
| Nutritional SupplementStandard whey protein | Other | 12g per day of whey protein isolate (WPI) for 56 days (8-weeks) |
Primary outcome
Change in hemoglobin (g/L)
Time frame: Baseline (week 0), week 8
Change in serum hemoglobin level (g/L) from baseline to week 8
Change in serum ferritin (mg/L)
Time frame: Baseline (week 0), week 8
Change in serum ferritin (micrograms/L) from baseline to end of study
Integumentary outcomes
Time frame: 8-weeks
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.
6 secondary outcomes
Change in Body mass index (BMI)
Time frame: Baseline (week 0), week 8
Percentage change in body composition compartments
Time frame: Baseline (week 0), week 8
Change in glycated hemoglobin (HbA1c %)
Time frame: Baseline (week 0), week 8
Change in fasting plasma glucose (mg/dL)
Time frame: Baseline (week 0), week 8
Change in Inflammatory biomarkers
Time frame: Baseline (week 0), week 8
Change in zonulin and gherlin
Time frame: Baseline (week 0), week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Protection participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Halvadar, PhD principal investigator
GPH Biotech LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation and Nutritional Supplement in people with Overweight (BMI > 25) and Weight Loss, run by Hofseth Biocare ASA at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin (g/L) (time frame: Baseline (week 0), week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.