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

26. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: Nutritional supplementation
ProGo is a proprietary mix of bioactive peptides.
Andre navne:
  • ProGo
Aktiv komparator: 12g per day of whey protein isolate (WPI) for 56 days (8-weeks)
Andet: Nutritional Supplement
Standard whey protein

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin (g/L)
Tidsramme: Baseline (week 0), week 8
Change in serum hemoglobin level (g/L) from baseline to week 8
Baseline (week 0), week 8
Change in serum ferritin (mg/L)
Tidsramme: Baseline (week 0), week 8
Change in serum ferritin (micrograms/L) from baseline to end of study
Baseline (week 0), week 8
Integumentary outcomes
Tidsramme: 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.
8-weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body mass index (BMI)
Tidsramme: Baseline (week 0), week 8
Change in BMI (%) from baseline to end of study
Baseline (week 0), week 8
Percentage change in body composition compartments
Tidsramme: Baseline (week 0), week 8
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 %)
Tidsramme: Baseline (week 0), week 8
Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study
Baseline (week 0), week 8
Change in fasting plasma glucose (mg/dL)
Tidsramme: Baseline (week 0), week 8
Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study
Baseline (week 0), week 8
Change in Inflammatory biomarkers
Tidsramme: Baseline (week 0), week 8
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
Tidsramme: Baseline (week 0), week 8
Assessment of change in markers of leaky gut and appetite from baseline to end of study
Baseline (week 0), week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hofseth Biocare ASA

Efterforskere

  • Ledende efterforsker: Freddy Halvadar, PhD, GPH Biotech LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. juli 2019

Primær færdiggørelse (Faktiske)

3. november 2019

Studieafslutning (Faktiske)

3. januar 2020

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPH001-19

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Protection participant privacy.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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