Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Lifestyle Intervention to Improve Muscle Function in Older Adults

19. maj 2026 opdateret af: Candida Rebello, Pennington Biomedical Research Center
The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pennington Biomedical Research Center
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age > 50 years.
  2. Body mass index (BMI) ≥ 30 kg/m2.
  3. Homeostatic model assessment of insulin resistance ≥ 3.
  4. Mini-Mental State Examination (MMSE) > 25.
  5. Geriatric Depression Scale-15 (GDS-15) < 9.
  6. Sedentary (less than 90 minutes/week of moderate to vigorous activity).
  7. Ability to provide written informed consent.

Exclusion Criteria:

  1. Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
  2. Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
  3. Fluctuation in body weight > 3 kg in the preceding two months
  4. Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Structured nutrition plan + exercise
Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
Adfærdsmæssigt: Structured nutrition plan
Participants will receive a structured nutrition plan.
Adfærdsmæssigt: Supervised Exercise
Participants will complete aerobic and resistance training under supervision three times per week.
Aktiv komparator: Typical or usual diet + exercise
Participants receive a typical or usual diet, and exercise under supervision
Adfærdsmæssigt: Supervised Exercise
Participants will complete aerobic and resistance training under supervision three times per week.
Adfærdsmæssigt: Typical or usual diet
Participants will receive a diet representing the usual diet in this population.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fat mass
Tidsramme: Change from baseline to 12 weeks
Fat mass measured by dual X-ray absorptiometry
Change from baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skeletal muscle mass
Tidsramme: Change in from baseline to 12 weeks
Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method
Change in from baseline to 12 weeks
Short physical performance battery
Tidsramme: Change from baseline to 12 weeks
A test of physical function
Change from baseline to 12 weeks
Hand-grip strength
Tidsramme: Change from baseline to 12 weeks
Hand grip strength will be measured using a hand dynamometer
Change from baseline to 12 weeks
Knee strength
Tidsramme: Change from baseline to12 weeks
Knee strength will be measured quantified using Biodex dynamometry
Change from baseline to12 weeks
Energy stores
Tidsramme: 12 weeks
Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method
12 weeks
Hormonal regulation of energy balance
Tidsramme: Change from baseline to 12 weeks
Blood concentrations of glucagon-like peptide 1
Change from baseline to 12 weeks
Hormonal regulation of energy balance
Tidsramme: Change from baseline to 12 weeks
Blood concentrations of gastric inhibitory peptide
Change from baseline to 12 weeks
Hormonal regulation of energy balance
Tidsramme: Change from baseline to 12 weeks
Blood concentrations of cortisol
Change from baseline to 12 weeks
Hormonal regulation of energy balance
Tidsramme: Change from baseline to 12 weeks
Blood concentrations of leptin
Change from baseline to 12 weeks
Cardiorespiratory fitness
Tidsramme: Change in VO2max from baseline to 12 weeks
VO2max
Change in VO2max from baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pennington Biomedical Research Center

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Candida J Rebello, PhD, RD, Pennington Biomedical Research Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2030

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PBRC-2025-060
  • 1R01AG092725-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

At this time, we do not have plans to share IPD. We may consider it after the study results have been publicly disseminated

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kropssammensætning

Kliniske forsøg med Structured nutrition plan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner