Effekter av omega-3 og myseproteintilskudd på mager masse hos eldre voksne (W-3 and Whey)
Effekter av omega-3 og myseproteintilskudd på mager masse og styrkeøkninger hos eldre voksne som utfører motstandstrening: en randomisert, dobbeltblind og placebokontrollert 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Minas Gerais
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Uberlândia, Minas Gerais, Brasil, 38400-902
- Federal University of Uberlandia
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Endringer i styrke (kg) ved bruk av dynamometer hos postmenopausale kvinner
Tidsramme: opptil 12 uker
|
opptil 12 uker
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of oxidative stress and inflammation biomarkers
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Nevromuskulære manifestasjoner
- Patologiske tilstander, anatomiske
- Muskelatrofi
- Atrofi
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Sarkopeni
- Aminosyrer, peptider og proteiner
- Proteiner
- Fettsyrer
- Lipider
- Mat
- Kosthold, mat og ernæring
- Fysiologiske fenomener
- Mat og drikke
- Meieriprodukter
- Fettsyrer, umettet
- Oljer
- Kostholdsfett
- Fett
- Melk
- Fettsyrer, Omega-3
- Kostholdsfett, umettet
- Fiskeoljer
- Kostholdsproteiner
- Melkeproteiner
- Dyreproteiner, kosthold
- Myse
- Docosahexaensyrer
- Myseproteiner
Andre studie-ID-numre
- 5.728.049
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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