- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05862779
Effekter av omega-3 och vassleproteintillskott på mager massa hos äldre vuxna (W-3 and Whey)
Effekter av omega-3 och vassleproteintillskott på mager massa och styrkeökningar hos äldre vuxna som utför motståndsträning: en randomiserad, dubbelblind och placebokontrollerad studie
To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass, muscle strength, metabolomic and lipidomic profiles, and biomarkers of oxidative stress and inflammation in older adults undergoing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. All will perform the same exercise protocol for 12 weeks.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minas Gerais
-
Uberlândia, Minas Gerais, Brasilien, 38400-902
- Federal University of Uberlandia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Postmenopausal women (at least 1 year of menstrual interruption, self-reported);
- To be able to practice strength exercises;
- To be able to carry out supplementation;
- Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;
- No history of stroke or acute myocardial infarction;
- Not being a smoker and/or alcoholic;
- Do not perform hormone replacement therapy;
- Do not use anti-inflammatory drugs;
- To have normal kidney function;
- To submit a medical certificate of health that proves that the individual is able to perform exercises.
Exclusion Criteria:
- Do not provide the necessary information for the development of the study;
- Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, cardiovascular, and kidney and/or liver diseases.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo Group
Group supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks |
The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. |
|
Experimentell: Whey Protein + Placebo
Group supplemented with isolated whey protein (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. |
|
Experimentell: Omega 3 + Placebo
Group supplemented with omega-3 (5g/day) and maltodextrin (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. |
|
Experimentell: Omega 3 + Whey Protein
Group supplemented with omega-3 (5g/day) and whey protein (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
Tidsram: up to 12 weeks
|
up to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Förändringar i styrka (kg) med dynamometer hos postmenopausala kvinnor
Tidsram: upp till 12 veckor
|
upp till 12 veckor
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of oxidative stress and inflammation biomarkers
Tidsram: up to 12 weeks
|
Oxidative stress biomarkers will be assessed in blood and saliva, whereas inflammatory biomarkers will be assessed in blood only. Blood and saliva samples will be collected before and after the intervention. After an overnight fast, 20 mL of blood will be collected into heparinized tubes. A portion of the blood will be used for whole-blood stimulation with or without 10 ng/mL lipopolysaccharide (LPS; Escherichia coli O111) for 6 hours at 37°C in 5% CO₂. Following incubation, the supernatant will be collected for the assessment of inflammatory cytokines by ELISA. The remaining blood will be centrifuged at 4°C and 3,200 rpm for 10 minutes, aliquoted, and stored at -80°C until analysis of oxidative stress biomarkers. |
up to 12 weeks
|
|
Metabolomics and lipidomics analyses
Tidsram: up to 12 weeks
|
For metabolomic analysis, 100 μL of serum will be extracted with spectroscopic-grade methanol, homogenized, centrifuged, concentrated under vacuum, reconstituted in methanol, and filtered through a 0.22-μm filter. For lipidomic analysis, 100 μL of serum will be extracted using dichloromethane and methanol. The organic phase will be collected, concentrated under vacuum at 40°C, reconstituted in dichloromethane, and transferred to analytical vials. Metabolomic and lipidomic profiles will be analyzed using liquid chromatography coupled with high-resolution mass spectrometry (LC-MS) and gas chromatography coupled with mass spectrometry (GC-MS). Metabolites and lipids will be identified based on accurate mass, mass spectral data, and comparison with databases and published literature. |
up to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Neuromuskulära manifestationer
- Patologiska tillstånd, anatomiska
- Muskelatrofi
- Atrofi
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Sarkopeni
- Aminosyror, peptider och proteiner
- Proteiner
- Fettsyror
- Lipider
- Mat
- Diet, mat och näring
- Fysiologiska fenomen
- Mat och dryck
- Mejeriprodukter
- Fettsyror, omättade
- Oljor
- Kostfetter
- Fetter
- Mjölk
- Fettsyror, omega-3
- Kostfetter, omättade
- Fiskoljor
- Dietproteiner
- Mjölkproteiner
- Animaliska proteiner, kost
- Vassla
- Docosahexaensyror
- Vassleproteiner
Andra studie-ID-nummer
- 5.728.049
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .