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

Starting soon · Not applicable

Conditions studied: Sarcopenia in Elderly

In brief

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.

Key facts

Study ID

NCT07689994

Run by

Finis Terrae University

People needed

102

Starts

2026-08-01

Expected to finish

2027-03-01

Last updated by the study team

2026-07-08

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Universidad Finis Terrae — Santiago, Chile

Full record on ClinicalTrials.gov

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