Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

26. mai 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

14

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Annen: Nutritional supplementation
ProGo is a proprietary mix of bioactive peptides.
Andre navn:
  • ProGo
Aktiv komparator: 12g per day of whey protein isolate (WPI) for 56 days (8-weeks)
Annen: Nutritional Supplement
Standard whey protein

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hofseth Biocare ASA

Etterforskere

  • Hovedetterforsker: Freddy Halvadar, PhD, GPH Biotech LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. juli 2019

Primær fullføring (Faktiske)

3. november 2019

Studiet fullført (Faktiske)

3. januar 2020

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SPH001-19

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Protection participant privacy.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere