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.
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.
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.
Parallel
Standard chocolate-flavored cake
Dietary supplementParticipants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
Leucine-Enriched Chocolate Cake
Dietary supplementParticipants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
Leucine Plus Seaweed Flour-Enriched Chocolate Cake
Dietary supplementParticipants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour daily for 28 days.
Change from baseline in fasting serum transthyretin concentration at day 28.
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.
Change from baseline in handgrip strength at day 28.
Handgrip strength (kg) measured by dynamometry under standardized conditions. The operational measure, such as the best of three valid attempts.
Change from baseline in 4-meter gait speed at day 28.
Usual gain speed (m/s) calculated from the 4-meter walk test under standardized condition.
Change from baseline in appendicular muscle mass index at day 28.
Appendicular skeletal muscle mass index (kg/m2) measured calculated as appendicular skeletal muscle mass divided by height squared
Percentage (%) of prescribed study product serving consumed during the intervention.
Adherence calculated from returned product counts and participant self-report as number of consumed servings divided by the number of prescribed servings.
Number of participants with any adverse event.
Number of participants with at least one adverse event recorded from through the day 28 visit, regardless of relationship to the intervention.
Number of participants with serious adverse events.
Number of participants with at least one serious adverse event, as defined by applicable ethical and regulatory criteria
Number of participants with treatment-related adverse events
Number of participants with at least one adverse event assessed by the investigator as possibly, probably, or definitely related to the assigned study product.
Number of participants with gastrointestinal intolerance symptoms.
Number of participants reporting gastrointestinal symptoms such as nausea, abdominal pain, bloating, diarrhea, constipation, vomiting, or other symptoms recorded in the tolerability form.
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