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

NCT07689994 | Not Yet Recruiting

• 1 other identifier: 25-124
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia in Elderly

Keywords

Sarcopenia; Seaweed; Inflammatory status; older adults

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (5)

• Change from baseline in handgrip strength at day 28.

  28 days

• Change from baseline in 4-meter gait speed at day 28.

  28 days

• Change from baseline in appendicular muscle mass index at day 28.

  28 days

• Percentage (%) of prescribed study product serving consumed during the intervention.

  28 days

• Number of participants with adequate adherence during the intervention.

  28 days

Other Outcomes (17)

• Number of participants with any adverse event.

  28 days

• Number of participants with serious adverse events.

  28 days

• Number of participants with treatment-related adverse events

  28 days

Study Arms (3)

Control chocolate cake

PLACEBO COMPARATOR

One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days

Dietary Supplement: Standard chocolate-flavored cake

Leucine-enriched chocolate cake

ACTIVE COMPARATOR

One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days

Dietary Supplement: Leucine-Enriched Chocolate Cake

Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake

EXPERIMENTAL

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.

Dietary Supplement: Leucine Plus Seaweed Flour-Enriched Chocolate Cake

Interventions

Standard chocolate-flavored cake DIETARY_SUPPLEMENT

Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.

Also known as: Cake

Control chocolate cake

Leucine-Enriched Chocolate Cake DIETARY_SUPPLEMENT

Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.

Also known as: Leucin

Leucine-enriched chocolate cake

Leucine Plus Seaweed Flour-Enriched Chocolate Cake DIETARY_SUPPLEMENT

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.

Also known as: Seaweed

Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Finis Terrae University: lead

Study Sites (1)

Universidad Finis Terrae

Santiago, 8010000, Chile

Location

Related Publications (5)

• Calvani R, Marini F, Cesari M, Tosato M, Anker SD, von Haehling S, Miller RR, Bernabei R, Landi F, Marzetti E; SPRINTT consortium. Biomarkers for physical frailty and sarcopenia: state of the science and future developments. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):278-86. doi: 10.1002/jcsm.12051. Epub 2015 Jul 7.

  PMID: 26675566 BACKGROUND

• Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.

  PMID: 17138848 BACKGROUND

• Beaudart C, Alcazar J, Aprahamian I, Batsis JA, Yamada Y, Prado CM, Reginster JY, Sanchez-Rodriguez D, Lim WS, Sim M, von Haehling S, Woo J, Duque G; Global Leadership Initiative in Sarcopenia (GLIS) group. Health outcomes of sarcopenia: a consensus report by the outcome working group of the Global Leadership Initiative in Sarcopenia (GLIS). Aging Clin Exp Res. 2025 Mar 22;37(1):100. doi: 10.1007/s40520-025-02995-9.

  PMID: 40120052 BACKGROUND

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Leucine

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

María S Mariotti Celis, Ph D

CONTACT

+56 9 82332421; mmariotti@uft.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcome assessors, clinical personnel, investigators responsible for data collection, and the statistician will remain blinded to treatment allocation throughout the trial. Study products will be packaged identically and presented with the same external appearance and coded labeling. The individual responsible for packaging and maintaining the code-treatment correspondence will not participate in clinical assessments or statistical analyses. Unblinding will only be permitted in the event of a medical emergency or when knowledge of treatment allocation is essential for participant management. Any unblinding event will be documented, including the date, time, reason, requesting individual, and authorizing individual.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomized, single-center, double-blind, controlled, three-arm parallel clinical trial with a 1:1:1 allocation ratio and a 28-day follow-up period. The study is designed as an exploratory proof-of-concept trial focused on early efficacy and safety.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)