An interventional study of Placebo Group and Whey Protein + Placebo in Sarcopenia, sponsored by Federal University of Uberlandia. Active, not recruiting at 1 site in Brazil. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Federal University of Uberlandia · Not applicable, Interventional, and Prevention
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 75 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Federal University of Uberlandia is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks
Dietary Supplement: Placebo Group
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.
Dietary Supplement: Whey Protein + 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.
Dietary Supplement: Omega 3 + Placebo
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.
Dietary Supplement: Omega 3 + Whey Protein
The placebo group will receive 5 g per day of sunflower 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 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin.
Drug pages: Omega-3 fatty acid · Whey Proteins
The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein.
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
Time frame: up to 12 weeks
Changes in strength (kg) using dynamometer in postmenopausal women
Time frame: up to 12 weeks
Evaluation of oxidative stress and inflammation biomarkers
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.
Time frame: up to 12 weeks
Metabolomics and lipidomics analyses
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.
Time frame: up to 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jan 2027, 29 months after the start.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 29 months is above that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Omega-3 fatty acid · Whey Proteins
Federal University of Uberlandia