ObesityEarly Phase 1NCT06494566
Omega-3 Supplementation After Surgical Treatment of Obesity
A Early Phase 1 study testing Omega-3 and Mineral Oil in people with Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites in Brazil.
Trial summary
The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Omega-3 and Mineral Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Apr 2019to 4 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30kg/m2
- Candidate to bariatric and metabolic surgery
Who cannot join
- Use of Omega-3
- Contraindication to bioimpedance analysis
- Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-072
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, 90040-371
About this study
Official title: Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial
The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.
Read the detailed description
Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.
- Conditions
- Obesity
- Being tested
- Omega-3, Mineral Oil
- Keywords
- Sarcopenia, Lipid profile, Bariatric surgery, Metabolic surgery
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Omega-3 capsule
Mineral OilDietary supplement
Mineral Oil Capsule
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | Omega-3 2000mg (940mg of EPA and 660mg of DHA) in gastro resistant capsule by mouth once a day for 90 days, starting on day sixteen after surgery. Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery. Receives: Dietary Supplement: Mineral Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measurement with digital scale, patient standing, barefoot. kilograms (kg)
Measured: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Height
Height measurement, patient standing, barefoot. Unit of measurement: meters (m).
Measured: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Secondary outcomes (4)
Manual Grip Strength
Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf).
Measured: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
6-Minute Walk Test
Walking with measurements of distance covered. Units of measurement: meters.
Measured: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.
Electrical Bioimpedance - Percentage of muscle mass
Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).
Measured: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Electrical Bioimpedance - Body fat percentage
Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).
Measured: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start10 Apr 2019
- Primary completion30 Jul 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494566
- Sponsor's protocol ID
- 10311419.5.0000.5333
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bigolin AV, Iaroseski J, Carteri RB, Rodrigues GS, de Andrade R, De Carli LA, Razzera EL, Vian I, de Almeida da Silva R, Kalil AN, Ferreira LF. Effects of Omega-3 Supplementation in Sarcopenia After Bariatric Surgery: A Triple-Blind Randomized Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70321. doi: 10.1002/jcsm.70321.
PubMed 42289186
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06494566
- Acronym / sponsor ID
- 10311419.5.0000.5333
- Conditions
- Obesity
- Keywords
- Sarcopenia, Lipid profile, Bariatric surgery, Metabolic surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 10 Jul 2024 (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 study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.
Detailed description
Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega-3Omega-3 2000mg (940mg of EPA and 660mg of DHA) in gastro resistant capsule by mouth once a day for 90 days, starting on day sixteen after surgery. |
| Placebo | Placebo comparator | Dietary Supplement: Mineral OilMineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 30kg/m2
- Candidate to bariatric and metabolic surgery
Key exclusion criteria (4 listed)
- Use of Omega-3
- Contraindication to bioimpedance analysis
- Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics
- Refusal to participate
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 |
|---|---|---|
| Omega-3Omega-3 capsule | Dietary supplement | Omega-3 |
| Mineral OilMineral Oil Capsule | Dietary supplement | Placebo |
Primary outcome
Weight
Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Measurement with digital scale, patient standing, barefoot. kilograms (kg)
Height
Time frame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Height measurement, patient standing, barefoot. Unit of measurement: meters (m).
4 secondary outcomes
Manual Grip Strength
Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
6-Minute Walk Test
Time frame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.
Electrical Bioimpedance - Percentage of muscle mass
Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Electrical Bioimpedance - Body fat percentage
Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 42289186Bigolin AV, Iaroseski J, Carteri RB, Rodrigues GS, de Andrade R, De Carli LA, Razzera EL, Vian I, de Almeida da Silva R, Kalil AN, Ferreira LF. Effects of Omega-3 Supplementation in Sarcopenia After Bariatric Surgery: A Triple-Blind Randomized Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70321. doi: 10.1002/jcsm.70321.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 and Mineral Oil in people with Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight (time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.). 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?
On the ClinicalTrials.gov record for NCT06494566, which also lists 1 linked publication.
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 10 Jul 2024.