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Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia

1. juli 2026 oppdatert av: María Salomé Mariotti Celis, Finis Terrae University

Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia: A Prospective, Controlled, Randomized, Double-Blind, Three-Arm Parallel Clinical Trial

Sarcopenia and probable sarcopenia are associated with loss of muscle strength, functional impairment, frailty, and an increased risk of adverse outcomes in older adults. In short-term interventions, structural or functional changes may be modest, whereas certain serum biomarkers of metabolic-nutritional response may be more sensitive. In this protocol version, serum transthyretin (TTR) has been selected as the primary outcome, without assuming that it represents, by itself, a direct measure of muscle mass or overall clinical efficacy.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Sarcopenia is a progressive skeletal muscle disorder associated with aging and an increased risk of disability, hospitalization, dependency, and mortality. Contemporary consensus definitions identify low muscle strength as the primary characteristic of the condition, while muscle quantity or quality and physical performance are used to support the diagnosis and determine its severity.

In older adults, anabolic resistance reduces the muscle's responsiveness to habitual dietary protein intake. Leucine has been proposed as an amino acid capable of stimulating key anabolic pathways and therefore represents a plausible candidate for short-term nutritional interventions. In turn, Durvillaea incurvata flour provides bioactive compounds and dietary fiber with potential antioxidant and anti-inflammatory properties, although clinical evidence supporting its use in sarcopenia remains limited.

From a methodological perspective, a 28-day follow-up period may be sufficient to detect early metabolic and nutritional responses, but it may be insufficient to demonstrate robust clinical changes in muscle strength, muscle mass, or physical performance. For this reason, serum TTR has been selected as the primary short-term response outcome in the present protocol.

The selection of serum TTR as the primary outcome requires careful interpretation. Serum TTR levels may be influenced by protein-energy intake, liver function, inflammatory status, and intercurrent clinical conditions. Accordingly, in this protocol, serum TTR will not be interpreted as a direct surrogate of muscle mass or as a stand-alone measure of clinical efficacy. Rather, it will be considered a serum marker of early metabolic and nutritional response, whose interpretation will be complemented by functional, body composition, inflammatory, and safety-related outcomes.

This study is therefore designed as an exploratory, randomized proof-of-concept trial to determine whether the combination of leucine and seaweed flour improves serum TTR and whether this response is accompanied by consistent secondary changes in muscle strength, mobility, body composition, and the metabolic-inflammatory profile.

Studietype

Intervensjonell

Registrering (Antatt)

102

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

  • Navn: María S Mariotti Celis, Ph D
  • Telefonnummer: +56 9 82332421
  • E-post: mmariotti@uft.cl

Studiesteder

  • Chile
      • Santiago, Chile, 8010000
        • Universidad Finis Terrae
        • Ta kontakt med:
          • Cristian R Encina Acosta, Ph D
          • Telefonnummer: +56 9 62240100
          • E-post: cencinaa@uft.edu
        • Ta kontakt med:
          • Conrado S Camilo Manriquez
          • Telefonnummer: +56 9 77508471
          • E-post: ccamilo@uft.cl

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

Nei

Beskrivelse

Inclusion Criteria

  • Age between 60 and 80 years at the time of enrollment.
  • Ability to understand the study procedures and provide written informed consent.
  • SARC-F score ≥4 during screening.
  • Reduced muscle strength defined as handgrip strength <27 kg in men or <16 kg in women; alternatively, a time >15 seconds on the five-repetition chair stand test when handgrip dynamometry cannot be validly performed or is contraindicated.
  • Availability to attend study visits and comply with daily consumption of the study product for 28 days.
  • Willingness to provide fasting blood samples at the Day 0 and Day 28 visits. Exclusion Criteria
  • Cognitive impairment according to the abbreviated Mini-Mental State Examination (MMSE), using the operational cutoff approved for the study (≤13 points).
  • Clinically significant chronic liver disease, clinically significant chronic kidney disease, nephrotic syndrome, active cancer or recent oncological treatment, or any condition that may substantially affect serum TTR levels or increase participant risk.
  • Acute infection, acute inflammatory condition, or clinical decompensation at baseline that may interfere with the interpretation of serum TTR measurements.
  • Uncontrolled diabetes mellitus or any metabolic condition that, in the investigator's judgment, may increase the risks associated with the intervention.
  • Food allergy or intolerance to any component of the study product, including gluten, egg, milk, or other specific cake ingredients.
  • Use of leucine, HMB, or protein supplements within the previous 3 months.
  • Chronic use of systemic corticosteroids, immunosuppressive agents, or other therapies that may significantly alter the metabolic response under study.
  • Untreated thyroid disease or any other unstable endocrine disorder.
  • Clinically significant edema, severe dehydration, or any condition that may compromise the validity of bioelectrical impedance measurements.
  • Any medical, functional, social, or cognitive condition that may limit safe participation or adherence to the study protocol.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Control chocolate cake
One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days
Kosttilskudd: Standard chocolate-flavored cake
Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
Andre navn:
  • Cake
Aktiv komparator: Leucine-enriched chocolate cake
One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days
Kosttilskudd: Leucine-Enriched Chocolate Cake
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
Andre navn:
  • Leucin
Eksperimentell: Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake
One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour for 28 consecutive days.
Kosttilskudd: Leucine Plus Seaweed Flour-Enriched Chocolate Cake
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour daily for 28 days.
Andre navn:
  • Seaweed

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in fasting serum transthyretin concentration at day 28.
Tidsramme: 28 days
Fasting serum transthyretin (TTR; prealbumin) concentration (mg/dL) measured using Human Transthyretin/Prealbumin ELISA Kit (NBP2-60516, Bio-Techne, Novus Biologicals). The outcome is the change from Day 0 to Day 28 according to the Statistical Analysis Plan.
28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in handgrip strength at day 28.
Tidsramme: 28 days
Handgrip strength (kg) measured by dynamometry under standardized conditions. The operational measure, such as the best of three valid attempts.
28 days
Change from baseline in 4-meter gait speed at day 28.
Tidsramme: 28 days
Usual gain speed (m/s) calculated from the 4-meter walk test under standardized condition.
28 days
Change from baseline in appendicular muscle mass index at day 28.
Tidsramme: 28 days
Appendicular skeletal muscle mass index (kg/m2) measured calculated as appendicular skeletal muscle mass divided by height squared
28 days
Percentage (%) of prescribed study product serving consumed during the intervention.
Tidsramme: 28 days
Adherence calculated from returned product counts and participant self-report as number of consumed servings divided by the number of prescribed servings.
28 days
Number of participants with adequate adherence during the intervention.
Tidsramme: 28 days
Participants who consume at least 80% of prescribed study product serving during the 28-day intervention.
28 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with any adverse event.
Tidsramme: 28 days
Number of participants with at least one adverse event recorded from through the day 28 visit, regardless of relationship to the intervention.
28 days
Number of participants with serious adverse events.
Tidsramme: 28 days
Number of participants with at least one serious adverse event, as defined by applicable ethical and regulatory criteria
28 days
Number of participants with treatment-related adverse events
Tidsramme: 28 days
Number of participants with at least one adverse event assessed by the investigator as possibly, probably, or definitely related to the assigned study product.
28 days
Number of participants with gastrointestinal intolerance symptoms.
Tidsramme: 28 days
Number of participants reporting gastrointestinal symptoms such as nausea, abdominal pain, bloating, diarrhea, constipation, vomiting, or other symptoms recorded in the tolerability form.
28 days
Number of participants who discontinue the study product due to an adverse event.
Tidsramme: 28 days
Number of participants who permanently stop consuming the assigned study product because of an adverse event.
28 days
Change from baseline in serum TNF-alpha concentration at day 28.
Tidsramme: 28 days
Fasting serum TNF-alpha concentration (pg/mL) measured using Human TNF-alpha ELISA Kit.
28 days
Change from baseline in serum OX-SR1 concentration
Tidsramme: 28 days
Fasting serum OX-SR1 concentration (pg/mL) measured using Human Oxidative Stress Responsive (OXSR1) ELISA Kit
28 days
Change from baseline in fasting insulin concentration at day 28.
Tidsramme: 28 days
Fasting serum insulin (uUI/mL) measure using the validated assay.
28 days
Change from baseline in total cholesterol concentration at day 28
Tidsramme: 28 days
Fasting serum total cholesterol concentration (mg/dL) measured using the laboratory method.
28 days
Change from baseline in LDL cholesterol concentration at day 28.
Tidsramme: 28 days
Fasting serum LDL cholesterol concentration (mg/dL) measured using the laboratory method.
28 days
Change from baseline in HDL cholesterol concentration at day 28.
Tidsramme: 28 days
Fasting serum HDL cholesterol concentration (mg/dL) measured using the laboratory method.
28 days
Change from baseline in triglyceride concentration at day 28.
Tidsramme: 28 days
Fasting serum triglyceride concentration (mg/dL) measured using the laboratory method.
28 days
Change from baseline in serum glucose concentration at day 28.
Tidsramme: 28 days
Fasting serum glucose concentration (mg/dL) measured using the laboratory method
28 days
Change from baseline in serum total protein concentration at day 28.
Tidsramme: 28 days
Fasting serum total protein concentration (mg/dL) measured using the laboratory method.
28 days
Change from baseline in serum total bilirubin concentration at day 28.
Tidsramme: 28 days
Fasting serum total bilirubin concentration (U/L) measured using the laboratory method.
28 days
Change from baseline in serum albumin concentration at day 28.
Tidsramme: 28 days
Fasting serum albumin concentration (g/dL) measured using the laboratory method.
28 days
Change from baseline in serum globulin concentration at day 28.
Tidsramme: 28 days
Fasting serum globulin concentration (g/dL) measured using the laboratory method.
28 days

Samarbeidspartnere og etterforskere

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

Sponsor

Finis Terrae University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juli 2026

Først lagt ut (Faktiske)

8. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-124

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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