- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
- Doplněk stravy: Effects of Strength Training Combined With Omega-3s derived from algae on Muscle Strength and Cognitive Functions in adults
- Doplněk stravy: Effects of Strength Training Combined With Omega-3s derived from fish on Muscle Strength and Cognitive Functions in adults
- Doplněk stravy: Effects of Strength Training Combined With Placebo on Muscle Strength and Cognitive Functions in adults
- Doplněk stravy: Effects of Omega-3s derived from algae on Muscle Strength and Cognitive Functions in adults
- Doplněk stravy: Effects of Omega-3s derived from fish on Muscle Strength and Cognitive Functions in adults
- Doplněk stravy: Effects of Placebo on Muscle Strength and Cognitive Functions in adults
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Gdansk, Polsko
- University of Physical Education and Sport
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Experimentální: 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. |
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Komparátor placeba: 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. |
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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. |
|
Komparátor placeba: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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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
Časové okno: 12 weeks intervention
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12 weeks intervention
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- AWFiS/2026_1_MT
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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