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
2026年7月1日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
102
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：María S Mariotti Celis, Ph D
- 電話番号：+56 9 82332421
- メール：mmariotti@uft.cl
研究場所
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Santiago、チリ、8010000
- Universidad Finis Terrae
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コンタクト：
- Cristian R Encina Acosta, Ph D
- 電話番号：+56 9 62240100
- メール：cencinaa@uft.edu
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コンタクト：
- Conrado S Camilo Manriquez
- 電話番号：+56 9 77508471
- メール：ccamilo@uft.cl
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Control chocolate cake
One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days
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Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
他の名前：
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アクティブコンパレータ：Leucine-enriched chocolate cake
One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days
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Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
他の名前：
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実験的：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from baseline in fasting serum transthyretin concentration at day 28.
時間枠：28 days
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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.
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28 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from baseline in handgrip strength at day 28.
時間枠：28 days
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Handgrip strength (kg) measured by dynamometry under standardized conditions.
The operational measure, such as the best of three valid attempts.
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28 days
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Change from baseline in 4-meter gait speed at day 28.
時間枠：28 days
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Usual gain speed (m/s) calculated from the 4-meter walk test under standardized condition.
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28 days
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Change from baseline in appendicular muscle mass index at day 28.
時間枠：28 days
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Appendicular skeletal muscle mass index (kg/m2) measured calculated as appendicular skeletal muscle mass divided by height squared
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28 days
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Percentage (%) of prescribed study product serving consumed during the intervention.
時間枠：28 days
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Adherence calculated from returned product counts and participant self-report as number of consumed servings divided by the number of prescribed servings.
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28 days
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Number of participants with adequate adherence during the intervention.
時間枠：28 days
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Participants who consume at least 80% of prescribed study product serving during the 28-day intervention.
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28 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Number of participants with any adverse event.
時間枠：28 days
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Number of participants with at least one adverse event recorded from through the day 28 visit, regardless of relationship to the intervention.
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28 days
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Number of participants with serious adverse events.
時間枠：28 days
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Number of participants with at least one serious adverse event, as defined by applicable ethical and regulatory criteria
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28 days
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Number of participants with treatment-related adverse events
時間枠：28 days
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Number of participants with at least one adverse event assessed by the investigator as possibly, probably, or definitely related to the assigned study product.
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28 days
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Number of participants with gastrointestinal intolerance symptoms.
時間枠：28 days
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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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28 days
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Number of participants who discontinue the study product due to an adverse event.
時間枠：28 days
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Number of participants who permanently stop consuming the assigned study product because of an adverse event.
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28 days
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Change from baseline in serum TNF-alpha concentration at day 28.
時間枠：28 days
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Fasting serum TNF-alpha concentration (pg/mL) measured using Human TNF-alpha ELISA Kit.
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28 days
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Change from baseline in serum OX-SR1 concentration
時間枠：28 days
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Fasting serum OX-SR1 concentration (pg/mL) measured using Human Oxidative Stress Responsive (OXSR1) ELISA Kit
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28 days
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Change from baseline in fasting insulin concentration at day 28.
時間枠：28 days
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Fasting serum insulin (uUI/mL) measure using the validated assay.
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28 days
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Change from baseline in total cholesterol concentration at day 28
時間枠：28 days
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Fasting serum total cholesterol concentration (mg/dL) measured using the laboratory method.
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28 days
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Change from baseline in LDL cholesterol concentration at day 28.
時間枠：28 days
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Fasting serum LDL cholesterol concentration (mg/dL) measured using the laboratory method.
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28 days
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Change from baseline in HDL cholesterol concentration at day 28.
時間枠：28 days
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Fasting serum HDL cholesterol concentration (mg/dL) measured using the laboratory method.
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28 days
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Change from baseline in triglyceride concentration at day 28.
時間枠：28 days
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Fasting serum triglyceride concentration (mg/dL) measured using the laboratory method.
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28 days
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Change from baseline in serum glucose concentration at day 28.
時間枠：28 days
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Fasting serum glucose concentration (mg/dL) measured using the laboratory method
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28 days
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Change from baseline in serum total protein concentration at day 28.
時間枠：28 days
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Fasting serum total protein concentration (mg/dL) measured using the laboratory method.
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28 days
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Change from baseline in serum total bilirubin concentration at day 28.
時間枠：28 days
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Fasting serum total bilirubin concentration (U/L) measured using the laboratory method.
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28 days
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Change from baseline in serum albumin concentration at day 28.
時間枠：28 days
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Fasting serum albumin concentration (g/dL) measured using the laboratory method.
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28 days
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Change from baseline in serum globulin concentration at day 28.
時間枠：28 days
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Fasting serum globulin concentration (g/dL) measured using the laboratory method.
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28 days
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2026年10月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年7月1日
最初の投稿 (実際)
2026年7月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月8日
QC基準を満たした最後の更新が送信されました
2026年7月1日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。