Early Time-Restricted Eating Combined With Exercise in Older Adults
Effects of Early Time-Restricted Eating Combined With a Multicomponent Exercise Program on Bone Mineral Density, Gait, Balance, and Fall Risk in Healthy Older Adults: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone health, physical function, and fall risk in healthy older adults.
A total of approximately 44 healthy adults aged 60 years and older will be recruited and randomly assigned to one of two groups. The experimental group will follow an Early Time-Restricted Eating schedule combined with a structured multicomponent exercise program. The control group will not receive any dietary timing intervention or structured exercise program and will continue their usual daily lifestyle.
The intervention will last for 6 months. Participants in the exercise program will perform supervised sessions including resistance training, balance exercises, aerobic activity, and flexibility exercises. The Early Time-Restricted Eating protocol will involve consuming all daily food intake within an early daytime window while maintaining usual dietary quality and adequate energy and nutrient intake.
The main outcomes of the study include changes in bone mineral density, gait performance, balance, and fall risk. These outcomes will be measured at baseline and after the intervention period.
This study will provide evidence on whether combining early time-restricted eating with structured exercise can improve musculoskeletal health and functional ability, and reduce fall risk in older adults.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This randomized controlled trial is designed to evaluate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone mineral density, physical function, and fall risk in healthy older adults.
Participants will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The intervention will last for 6 months. The experimental group will follow an Early Time-Restricted Eating protocol, consisting of an 8-hour daily eating window (e.g., 07:00-15:00) followed by a 16-hour fasting period, in combination with a supervised multicomponent exercise program performed three times per week.
Each exercise session will last approximately 60 minutes and will include resistance training, balance exercises, aerobic activities, and flexibility exercises. Exercise sessions will be scheduled within the eating window to optimize energy availability and recovery. Dietary intake will be monitored to ensure adequate energy and protein consumption.
The control group will maintain their usual lifestyle without any structured dietary timing or exercise intervention.
Assessments will be conducted at baseline and after the intervention period. Data will be analyzed using repeated measures analysis to evaluate the effects of time, group, and their interaction on study outcomes.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Maha Gasmi, PhD
- Telefonnummer: +21699040701
- E-post: mahagasmi@hotmail.fr
Studer Kontakt Backup
- Navn: Kawther Missawi, PhD
- Telefonnummer: +21697323721
- E-post: kawther.missawi@hotmail.fr
Studiesteder
-
-
Manouba
-
Manouba, Manouba, Tunisia
- Manouba University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Aged 60 years or older
- Community-dwelling and generally healthy older adults
- Sedentary or moderately physically active
- Stable body weight during the previous 3 months (no intentional weight loss or gain >5%)
- Able to participate in a supervised exercise program
- Willing to comply with the time-restricted eating protocol and study procedures
- Able to provide written informed consent
Exclusion Criteria:
- Diagnosis of osteoporosis requiring pharmacological treatment
- Severe sarcopenia or major mobility limitations preventing safe exercise participation
- Cognitive impairment or diagnosed dementia affecting ability to follow instructions
- Presence of uncontrolled chronic diseases affecting bone metabolism (e.g., advanced renal disease, uncontrolled endocrine disorders)
- Current use of medications affecting bone metabolism (e.g., corticosteroids, anti-osteoporotic drugs)
- Participation in another structured exercise or dietary intervention program within the past 3 months
- Any medical condition that contraindicates moderate-intensity exercise
- Inability to comply with study protocol or follow-up assessments
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Early Time-Restricted Eating (eTRE)+Exercise Intervention Group
Participants in the experimental group will follow a 16:8 Early Time-Restricted Eating protocol combined with a supervised multicomponent exercise program for 6 months.
The exercise program includes resistance, aerobic, balance, and flexibility training, while the eating window is restricted to 8 hours per day with adequate energy and protein intake maintained.
|
Participants will follow an Early Time-Restricted Eating protocol consisting of a 16:8 fasting-feeding schedule.
All daily caloric intake will be consumed within an 8-hour window (e.g., 07:00-15:00), followed by a 16-hour fasting period.
Participants will be instructed to maintain adequate energy intake and consume at least 1.2 g/kg/day of protein, distributed across meals within the eating window.
Water intake will be allowed ad libitum during fasting hours.
A supervised multicomponent exercise program including resistance, aerobic, balance, and flexibility training.
Sessions will be performed three times per week for 6 months.
Resistance training will be performed at 60-80% of one-repetition maximum, aerobic training at moderate intensity (50-70% of maximum heart rate), and balance and flexibility exercises will be included in each session to improve functional capacity in older adults.
|
|
Ingen inngripen: Control
Participants in the control group will not receive any structured exercise program or dietary timing intervention and will be instructed to maintain their habitual diet and physical activity throughout the study period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone Mineral Density (BMD)
Tidsramme: Baseline and 6 months (pre-intervention and post-intervention)
|
Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DXA) at baseline and after the 6-month intervention period.
BMD measurements will be used to evaluate changes in bone health in response to the intervention in older adults.
|
Baseline and 6 months (pre-intervention and post-intervention)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait performance
Tidsramme: Baseline and 6 months (pre-intervention and post-intervention)
|
Gait performance will be assessed using a standardized 4-meter gait speed test at baseline and after the 6-month intervention period.
Participants will be instructed to walk at their usual pace, and gait speed will be used as an indicator of functional mobility and physical performance in older adults.
|
Baseline and 6 months (pre-intervention and post-intervention)
|
|
Balance
Tidsramme: Baseline and 6 months (pre-intervention and post-intervention)
|
Balance will be assessed using the Berg Balance Scale or a one-leg stance test at baseline and after the 6-month intervention period.
These tests will evaluate static and dynamic balance ability in older adults and will be used to determine changes in postural stability following the intervention.
|
Baseline and 6 months (pre-intervention and post-intervention)
|
|
Fall Risk
Tidsramme: Baseline and 6 months (pre-intervention and post-intervention)
|
Fall risk will be assessed using the Timed Up and Go (TUG) test at baseline and after the 6-month intervention period.
The TUG test measures the time required to stand up from a chair, walk 3 meters, turn, return, and sit down, and is used as an indicator of functional mobility and fall risk in older adults.
|
Baseline and 6 months (pre-intervention and post-intervention)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ISSEP-2025-086
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .