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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

102

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: María S Mariotti Celis, Ph D
  • Numero di telefono: +56 9 82332421
  • Email: mmariotti@uft.cl

Luoghi di studio

  • Chile
      • Santiago, Chile, 8010000
        • Universidad Finis Terrae
        • Contatto:
          • Cristian R Encina Acosta, Ph D
          • Numero di telefono: +56 9 62240100
          • Email: cencinaa@uft.edu
        • Contatto:
          • Conrado S Camilo Manriquez
          • Numero di telefono: +56 9 77508471
          • Email: ccamilo@uft.cl

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Control chocolate cake
One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days
Integratore alimentare: Standard chocolate-flavored cake
Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
Altri nomi:
  • Cake
Comparatore attivo: Leucine-enriched chocolate cake
One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days
Integratore alimentare: Leucine-Enriched Chocolate Cake
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
Altri nomi:
  • Leucin
Sperimentale: 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.
Integratore alimentare: 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.
Altri nomi:
  • Seaweed

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in fasting serum transthyretin concentration at day 28.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in handgrip strength at day 28.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 28 days
Participants who consume at least 80% of prescribed study product serving during the 28-day intervention.
28 days

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with any adverse event.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 28 days
Fasting serum insulin (uUI/mL) measure using the validated assay.
28 days
Change from baseline in total cholesterol concentration at day 28
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 28 days
Fasting serum globulin concentration (g/dL) measured using the laboratory method.
28 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Finis Terrae University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

8 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-124

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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