Prevention of Muscle Mass LossGPOWERNCT07772908
Efficacy of Protein Supplementation in Preventing Muscle Mass Loss During the Weight Loss Process.
A study testing Experimental arm in people with Prevention of Muscle Mass Loss, run by Althaia S.A Industria Farmaceutica at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate whether the supplement, combined with resistance training, prevents muscle mass loss during weight loss. The treatment will last four months and include clinical assessments, proper nutrition, and physical activity.. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Muscle Mass Loss
- What is being tested?
- Experimental arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jun 2026to Feb 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants of both sexes aged between 25 and 60 years.
- Ability to understand and accept participation in the study, indicated by signing the Informed Consent Form approved by the Ethics Committee.
- Good health status, determined by the absence of significant findings in medical history, physical examination, laboratory tests, and vital sign measurements.
- Agree to comply with the planned study procedures and attend visits.
- Participants with the capacity and motivation to perform resistance training 3 to 5 times per week (150 to 200 minutes/week); - Participants with a body mass index (BMI) ≥ 27.0 kg/m².
Who cannot join
- Known allergy to components of the investigational product or placebo;
- History of chronic use in the last 3 months or current use of medications or substances that affect the muscular system;
- Current history of type 1 or 2 diabetes mellitus, gastrointestinal, cardiovascular, renal, or hepatic diseases, or malignant neoplasm, considered clinically significant at the physician's discretion.
- Abuse of illicit drugs or alcohol, as clinically assessed by the investigator during screening.
- Having participated in a clinical study in the last 12 months at the investigator's discretion.
- Having any condition that prevents participation in the study at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate whether the supplement, combined with resistance training, prevents muscle mass loss during weight loss. The treatment will last four months and include clinical assessments, proper nutrition, and physical activity..
- Conditions
- Prevention of Muscle Mass Loss
- Being tested
- Experimental arm, Placebo
- Keywords
- Supplement, Muscle mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armDietary supplement
Also called Protein
Two doses, once a day.
PlaceboDietary supplement
Two doses, once daily
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Experimental arm Two doses, once daily.
Other Name:
Protein Receives: Dietary Supplement: Experimental arm |
| Dietary Supplement: Placebo | Placebo comparator | Dietary Supplement: Placebo Two doses, once daily
Other Name: Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat-free mass relative
Change in fat-free mass relative to baseline after 120 days of treatment, assessed by electrical bioimpedance.
Measured: 4 months
Evaluation of the supplement's effect on preventing muscle mass loss during weight loss.
Change in baseline mass compared to 120 days of treatment.
Measured: From the screening visit to the end of treatment - 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start9 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Muscle Mass LossStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Althaia S.A Industria Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772908
- Sponsor's protocol ID
- Althaia SA Ind. Farm.
- Acronym
- GPOWER
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Protein Supplementation in Preventing Muscle Mass Loss During the Weight Loss Process.
- ClinicalTrials.gov ID
- NCT07772908
- Acronym / sponsor ID
- GPOWER / Althaia SA Ind. Farm.
- Conditions
- Prevention of Muscle Mass Loss
- Keywords
- Supplement, Muscle mass
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Althaia S.A Industria FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
The objective of this study is to evaluate whether the supplement, combined with resistance training, prevents muscle mass loss during weight loss. The treatment will last four months and include clinical assessments, proper nutrition, and physical activity..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Experimental armDietary Supplement: Experimental arm Two doses, once daily. Other Name: Protein |
| Dietary Supplement: Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo Two doses, once daily Other Name: |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants of both sexes aged between 25 and 60 years.
- Ability to understand and accept participation in the study, indicated by signing the Informed Consent Form approved by the Ethics Committee.
- Good health status, determined by the absence of significant findings in medical history, physical examination, laboratory tests, and vital sign measurements.
- Agree to comply with the planned study procedures and attend visits.
- Participants with the capacity and motivation to perform resistance training 3 to 5 times per week (150 to 200 minutes/week); - Participants with a body mass index (BMI) ≥ 27.0 kg/m².
Key exclusion criteria (6 listed)
- Known allergy to components of the investigational product or placebo;
- History of chronic use in the last 3 months or current use of medications or substances that affect the muscular system;
- Current history of type 1 or 2 diabetes mellitus, gastrointestinal, cardiovascular, renal, or hepatic diseases, or malignant neoplasm, considered clinically significant at the physician's discretion.
- Abuse of illicit drugs or alcohol, as clinically assessed by the investigator during screening.
- Having participated in a clinical study in the last 12 months at the investigator's discretion.
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 |
|---|---|---|
| Experimental armAlso: ProteinTwo doses, once a day. | Dietary supplement | Dietary Supplement |
| PlaceboTwo doses, once daily | Dietary supplement | Dietary Supplement: Placebo |
Primary outcome
Change in fat-free mass relative
Time frame: 4 months
Change in fat-free mass relative to baseline after 120 days of treatment, assessed by electrical bioimpedance.
Evaluation of the supplement's effect on preventing muscle mass loss during weight loss.
Time frame: From the screening visit to the end of treatment - 120 days
Change in baseline mass compared to 120 days of treatment.
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 19 Aug 2026.
- Individual participant dataSharing planned: No
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 Experimental arm in people with Prevention of Muscle Mass Loss, run by Althaia S.A Industria Farmaceutica 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 5 inclusion and 6 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 19 Aug 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?
Change in fat-free mass relative (time frame: 4 months). The study lists 2 primary outcomes in all. 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 19 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.