The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health
26 maj 2026 uppdaterad av: Hofseth Biocare ASA
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maharashtra
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Mumbai, Maharashtra, Indien, 400020
- Spectrum Clinical Research
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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ProGo is a proprietary mix of bioactive peptides.
Andra namn:
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Aktiv komparator: 12g per day of whey protein isolate (WPI) for 56 days (8-weeks)
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Standard whey protein
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in hemoglobin (g/L)
Tidsram: Baseline (week 0), week 8
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Change in serum hemoglobin level (g/L) from baseline to week 8
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Baseline (week 0), week 8
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Change in serum ferritin (mg/L)
Tidsram: Baseline (week 0), week 8
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Change in serum ferritin (micrograms/L) from baseline to end of study
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Baseline (week 0), week 8
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Integumentary outcomes
Tidsram: 8-weeks
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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.
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8-weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Body mass index (BMI)
Tidsram: Baseline (week 0), week 8
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Change in BMI (%) from baseline to end of study
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Baseline (week 0), week 8
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Percentage change in body composition compartments
Tidsram: Baseline (week 0), week 8
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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.
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Baseline (week 0), week 8
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Change in glycated hemoglobin (HbA1c %)
Tidsram: Baseline (week 0), week 8
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Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study
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Baseline (week 0), week 8
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Change in fasting plasma glucose (mg/dL)
Tidsram: Baseline (week 0), week 8
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Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study
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Baseline (week 0), week 8
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Change in Inflammatory biomarkers
Tidsram: Baseline (week 0), week 8
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Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study
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Baseline (week 0), week 8
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Change in zonulin and gherlin
Tidsram: Baseline (week 0), week 8
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Assessment of change in markers of leaky gut and appetite from baseline to end of study
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Baseline (week 0), week 8
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Freddy Halvadar, PhD, GPH Biotech LLC
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 juli 2019
Primärt slutförande (Faktisk)
3 november 2019
Avslutad studie (Faktisk)
3 januari 2020
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
26 maj 2026
Första postat (Faktisk)
1 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SPH001-19
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Protection participant privacy.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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