Lifestyle Intervention to Improve Muscle Function in Older Adults
1. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Candida J Rebello, PhD, RD
- Telefonnummer: 12257633159
- E-post: Candida.Rebello@pbrc.edu
Studer Kontakt Backup
- Navn: Reilly Roberts A Project Manager, MS
- Telefonnummer: 225-763-2854
- E-post: candidajoan@hotmail.com
Studiesteder
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70808
- Rekruttering
- Pennington Biomedical Research Center
-
Ta kontakt med:
- Candida J Rebello, PhD, RD
- Telefonnummer: 225-763-3159
- E-post: Candida.Rebello@pbrc.edu
-
Ta kontakt med:
- Reilly Roberts A Project Manager, MS
- Telefonnummer: 225-763-2854
- E-post: Reilly.Roberts@pbrc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age > 50 years.
- Body mass index (BMI) ≥ 30 kg/m2.
- Homeostatic model assessment of insulin resistance ≥ 3.
- Mini-Mental State Examination (MMSE) > 25.
- Geriatric Depression Scale-15 (GDS-15) < 9.
- Sedentary (less than 90 minutes/week of moderate to vigorous activity).
- Ability to provide written informed consent.
Exclusion Criteria:
- 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.
- Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
- Fluctuation in body weight > 3 kg in the preceding two months
- Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Structured nutrition plan + exercise
Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
|
Participants will receive a structured nutrition plan.
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
|
Participants will complete aerobic and resistance training under supervision three times per week.
Participants will receive a diet representing the usual diet in this population.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Candida J Rebello, PhD, RD, Pennington Biomedical Research Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juli 2026
Primær fullføring (Antatt)
1. desember 2030
Studiet fullført (Antatt)
1. desember 2030
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
14. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBRC-2025-060
- 1R01AG092725-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .