SarcopeniaW-3 and WheyNCT05862779
Effects of Omega-3 and Whey Protein Supplementation on Lean Mass in Older Adults
A study testing Omega 3 + Whey Protein in people with Sarcopenia, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Omega 3 + Whey Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38400-902
About this study
Official title: Effects of Omega-3 and Whey Protein Supplementation on Lean Mass and Strength Gains in Older Adults Performing Resistance Exercise: A Randomized, Double-Blind and Placebo-Controlled Study
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.
- Conditions
- Sarcopenia
- Being tested
- Placebo Group, Whey Protein + Placebo, Omega 3 + Placebo, Omega 3 + Whey Protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GroupDietary supplement
The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin.
Whey Protein + PlaceboDietary supplement
The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil.
Omega 3 + PlaceboDietary supplement
The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin.
Omega 3 + Whey ProteinDietary supplement
The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Group supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks Receives: Dietary Supplement: Placebo Group |
| Whey Protein + Placebo | Experimental | 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. Receives: Dietary Supplement: Whey Protein + Placebo |
| Omega 3 + Placebo | Experimental | Group supplemented with omega-3 (5g/day) and maltodextrin (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. Receives: Dietary Supplement: Omega 3 + Placebo |
| Omega 3 + Whey Protein | Experimental | 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. Receives: Dietary Supplement: Omega 3 + Whey Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
Measured: up to 12 weeks
Secondary outcomes (1)
Changes in strength (kg) using dynamometer in postmenopausal women
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start30 Jul 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Prado de Oliveira, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862779
- Sponsor's protocol ID
- 5.728.049
- Acronym
- W-3 and Whey
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 and Whey Protein Supplementation on Lean Mass and Strength Gains in Older Adults Performing Resistance Exercise: A Randomized, Double-Blind and Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05862779
- Acronym / sponsor ID
- W-3 and Whey / 5.728.049
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo GroupGroup supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks |
| Whey Protein + Placebo | Experimental | Dietary Supplement: Whey Protein + PlaceboGroup 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. |
| Omega 3 + Placebo | Experimental | Dietary Supplement: Omega 3 + PlaceboGroup supplemented with omega-3 (5g/day) and maltodextrin (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
| Omega 3 + Whey Protein | Experimental | Dietary Supplement: Omega 3 + Whey ProteinGroup supplemented with omega-3 (5g/day) and whey protein (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo GroupThe placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. | Dietary supplement | Placebo Group |
| Whey Protein + PlaceboThe whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. | Dietary supplement | Whey Protein + Placebo |
| Omega 3 + PlaceboThe omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. | Dietary supplement | Omega 3 + Placebo |
| Omega 3 + Whey ProteinThe omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. | Dietary supplement | Omega 3 + Whey Protein |
Primary outcome
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
Time frame: up to 12 weeks
1 secondary outcome
Changes in strength (kg) using dynamometer in postmenopausal women
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 + Whey Protein in people with Sarcopenia, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.