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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

2026년 7월 1일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

102

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: María S Mariotti Celis, Ph D
  • 전화번호: +56 9 82332421
  • 이메일: mmariotti@uft.cl

연구 장소

  • 칠레
      • Santiago, 칠레, 8010000
        • Universidad Finis Terrae
        • 연락하다:
          • Cristian R Encina Acosta, Ph D
          • 전화번호: +56 9 62240100
          • 이메일: cencinaa@uft.edu
        • 연락하다:
          • Conrado S Camilo Manriquez
          • 전화번호: +56 9 77508471
          • 이메일: ccamilo@uft.cl

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Control chocolate cake
One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days
건강 보조 식품: Standard chocolate-flavored cake
Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
다른 이름들:
  • Cake
활성 비교기: Leucine-enriched chocolate cake
One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days
건강 보조 식품: Leucine-Enriched Chocolate Cake
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
다른 이름들:
  • Leucin
실험적: 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.
건강 보조 식품: 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.
다른 이름들:
  • Seaweed

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in fasting serum transthyretin concentration at day 28.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in handgrip strength at day 28.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 28 days
Participants who consume at least 80% of prescribed study product serving during the 28-day intervention.
28 days

기타 결과 측정

결과 측정
측정값 설명
기간
Number of participants with any adverse event.
기간: 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.
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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.
기간: 28 days
Fasting serum insulin (uUI/mL) measure using the validated assay.
28 days
Change from baseline in total cholesterol concentration at day 28
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 28 days
Fasting serum globulin concentration (g/dL) measured using the laboratory method.
28 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Finis Terrae University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 7월 1일

처음 게시됨 (실제)

2026년 7월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 1일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-124

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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