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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Maha Gasmi, PhD
- Número de telefone: +21699040701
- E-mail: mahagasmi@hotmail.fr
Estude backup de contato
- Nome: Kawther Missawi, PhD
- Número de telefone: +21697323721
- E-mail: kawther.missawi@hotmail.fr
Locais de estudo
-
-
Manouba
-
Manouba, Manouba, Tunísia
- Manouba University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Bone Mineral Density (BMD)
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gait performance
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ISSEP-2025-086
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .