- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07763574
Effects of Strength Training Combined With Sustainable Source of Omega-3 Fatty Acids on Muscle Strength and Cognitive Functions in Adults Controlled Trial
The purpose of the study is to evaluate the effects of 12-week supplementation with algae-derived DHA combined with strength training on muscle strength, neuromuscular parameters, post-exercise inflammation and cognitive functions in healthy adults compared to fish-derived EPA and DHA combined with strength training, strength training alone and control group.
The research methods and measurement tools include:
- Body composition assessed prior to the training intervention and after 12 weeks of training: body mass index (BMI) and body composition - fat mass [kg], body fat percentage [%] and skeletal muscle mass [kg] - will be determined using bioimpedance methods (In Body 720, Biospace, Seoul, Korea) following an overnight fast.
- Assessment of physical activity levels using the long version of the International Physical Activity Questionnaire (IPAQ).
- Assessment of mood (UMACL Adjective Mood Scale) and depression (DASS-21, Beck Depression Scale).
- The SarQoL (Sarcopenia and Quality of Life) questionnaire, used to specifically assess quality of life in people with reduced muscle mass and function.
- Assessment of participants' diet: each participant will be required to record their diet in 3-day food diaries (to be checked on the first day of testing).
- Blood sampling: blood will be collected from each participant at two time points before and after the intervention (on an empty stomach, and 40 minutes after the training session). The following will be collected: 1 × 6 ml blood count tube and 3 tubes with a clotting activator, with a total volume of 20 ml. Blood will be collected before the start of the training intervention and after 12 weeks of training. The tubes will be centrifuged at 4 °C (4000 × g for 10 minutes). The serum, plasma and erythrocyte fractions will then be frozen at -80 °C until analysis.
- Peak force, relative peak force and force at 150, 200 and 250 milliseconds during isometric mid-thigh pull-ups using a Kistler platform (Kistler dynamometer platform, model 9286BA, with MARS software). The maximum load (1RM) will also be measured for each participant. Upper limb grip strength will be measured using a SAEHAN electronic dynamometer.
- In addition, muscle electrical activity using a Noraxon Telemyo surface electromyograph will be assessed.
- Cognitive function will be assessed using the following tests: the Stroop Test, the Corsi Block-Tapping Task and the Pattern Separation Task.
All analysis (beside IPAQ) will be performed before and after 12 weeks of intervention.
- During the study, all participants will take part in a strength training session (around 40 mins duration) led by an experienced trainer to stimulate the muscles to release myokines.
- Blood tests will include: BDNF, IGF-1, IL-6, hs-CRP, TNF-alpha, and IL-1B as well as concentrations of metabolites of the kynurenine pathway.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Suplemento dietético: Effects of Strength Training Combined With Omega-3s derived from algae on Muscle Strength and Cognitive Functions in adults
- Suplemento dietético: Effects of Strength Training Combined With Omega-3s derived from fish on Muscle Strength and Cognitive Functions in adults
- Suplemento dietético: Effects of Strength Training Combined With Placebo on Muscle Strength and Cognitive Functions in adults
- Suplemento dietético: Effects of Omega-3s derived from algae on Muscle Strength and Cognitive Functions in adults
- Suplemento dietético: Effects of Omega-3s derived from fish on Muscle Strength and Cognitive Functions in adults
- Suplemento dietético: Effects of Placebo on Muscle Strength and Cognitive Functions in adults
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Gdansk, Polônia
- University of Physical Education and Sport
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria for the training group:
- 1-2 years of strength training experience,
- without chronic or autoimmune diseases,
- between the ages of 25 and 35,
- not obese,
- not taking omega-3 fatty acids,
- not taking protein, BCAAs, creatine, anabolic steroids, or other supplements
- for women: not pregnant or breastfeeding, and at least 1 year after childbirth (to allow for hormonal balance to stabilize).
For the control group (non-exercisers):
- Requirements as above, except for exercise: we recruit individuals who exercise less than 1 hour per week
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: algae-derived DHA + strength training
3g of a algae-derived DHA + strength training 3 times a week through 12 weeks
|
Healthy men and women with few years of training experience will participate in a 12-week strength training program combined with 3g/per day DHA from algae supplementation. The training will be 3 times a week, with 1-hour strength-training exercises for the upper and lower body. At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins. |
|
Experimental: fish-derived omega-3 + strength training
3g of a fish-derived omega-3 (EPA+DHA) + strength training 3 times a week through 12 weeks
|
Healthy men and women with few years of training experience will participate in a 12-week strength training program combined with EPA and DHA from fish supplementation (3g per day). The training will be 3 times a week, with 1-hour strength-training exercises for the upper and lower body. At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins. |
|
Comparador de Placebo: placebo + strength training
3g of a placebo + strength training 3 times a week through 12 weeks
|
Healthy men and women with few years of training experience will participate in a 12-week strength training program combined with placebo supplementation. The training will be 3 times a week, with 1-hour strength-training exercises for the upper and lower body. At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins. |
|
Comparador Ativo: algae-derived DHA without strength training
3g of a algae-derived DHA through 12 weeks
|
Healthy, untrained men and women will participate in a 12-week DHA from algae supplementation (3g per day).
At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins.
|
|
Comparador Ativo: fish-derived omega-3 without strength training
3g of a fish-derived omega-3 (EPA+DHA) through 12 weeks
|
Healthy, untrained men and women will participate in a 12-week EPA and DHA from fish supplementation (3g per day). At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins. |
|
Comparador de Placebo: placebo without strength training
3g of a placebo through 12 weeks
|
Healthy, untrained men and women will participate in a 12-week placebo supplementation.
At the beginning and end of the intervention, muscle strength will be assessed along with EMG, cognitive function will be evaluated, and blood samples will be collected to measure specific proteins.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Peak force (N), relative peak force (N/kg bw) and force at 150, 200, and 250 milliseconds (N) during Isometric Mid-Thigh Pull (IMTP) and Back Squat
Prazo: 12 weeks intervention
|
12 weeks intervention
|
Colaboradores e Investigadores
Patrocinador
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
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- AWFiS/2026_1_MT
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