Obesity MorbidAMINOBNCT06309563
Metabolic Effects of a Diet Replaced With Essential Amino Acids
A study testing Aminoacid supplementation in people with Obesity Morbid and Weight Loss, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Obesity Morbid, Weight Loss
- What is being tested?
- Aminoacid supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2023to 31 Dec 2026
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity (BMI >35kg/m2)
Who cannot join
- Type 2 diabetes mellitus
- Renal failure
- Heart failure (New York Heart Association NYHA, class IV)
- Liver cirrhosis
- Neoplasms
- Muscular or non-autonomic pathologies
Show all 13Show fewer
- Neurological-neurodegenerative pathologies
- Cognitive decline
- Non-menopausal women.
- Patients who have undergone bariatric surgery in the previous 12 months
- Patients on pharmacological treatment for weight loss in the last three weeks
- Patients using vitamin and amino acid supplements in the last three weeks
- Patients on hormone therapy (e.g. L-thyroxine, testosterone).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano, Site Piancavallo
Oggebbio, Verbania, 28921
Amelia Brunani, MD, 390323514232, brunani@auxologico.it
About this study
Official title: Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity
The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.
1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.
- Conditions
- Obesity Morbid, Weight Loss
- Being tested
- Aminoacid supplementation, Placebo
- Keywords
- Muscle mass during weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminoacid supplementationDietary supplement
Also called EAA-AC, Controls
Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks
PlaceboDietary supplement
Low-calorie and low-protein diet + placebo for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aminoacids | Active comparator | Patients with obesity treated with essential aminoacids (EAA-AC) Receives: Dietary Supplement: Aminoacid supplementation |
| Control | Placebo comparator | Patients with obesity treated with placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Change in muscle mass during weight loss assessed through changes in body composition
Measured: At baseline and at 2 weeks after start of intervention
Secondary outcomes (1)
6 minute walking test (6MWT)
Change in distance covered in 6 minutes of walking during weight loss
Measured: At baseline and at 2 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start30 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Obesity MorbidStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309563
- Sponsor's protocol ID
- 31J301
- Acronym
- AMINOB
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nisoli E, Falcone S, Tonello C, Cozzi V, Palomba L, Fiorani M, Pisconti A, Brunelli S, Cardile A, Francolini M, Cantoni O, Carruba MO, Moncada S, Clementi E. Mitochondrial biogenesis by NO yields functionally active mitochondria in mammals. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16507-12. doi: 10.1073/pnas.0405432101. Epub 2004 Nov 15.
PubMed 15545607
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity
- ClinicalTrials.gov ID
- NCT06309563
- Acronym / sponsor ID
- AMINOB / 31J301
- Conditions
- Obesity Morbid, Weight Loss
- Keywords
- Muscle mass during weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 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 effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.
1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminoacids | Active comparator | Dietary Supplement: Aminoacid supplementationPatients with obesity treated with essential aminoacids (EAA-AC) |
| Control | Placebo comparator | Dietary Supplement: PlaceboPatients with obesity treated with placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity (BMI >35kg/m2)
Key exclusion criteria (13 listed)
- Type 2 diabetes mellitus
- Renal failure
- Heart failure (New York Heart Association NYHA, class IV)
- Liver cirrhosis
- Neoplasms
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 |
|---|---|---|
| Aminoacid supplementationAlso: EAA-AC, ControlsLow-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks | Dietary supplement | Aminoacids |
| PlaceboLow-calorie and low-protein diet + placebo for 2 weeks | Dietary supplement | Control |
Primary outcome
Muscle mass
Time frame: At baseline and at 2 weeks after start of intervention
Change in muscle mass during weight loss assessed through changes in body composition
1 secondary outcome
6 minute walking test (6MWT)
Time frame: At baseline and at 2 weeks after start of intervention
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 31 Mar 2026.
- Background: PubMed 15545607Nisoli E, Falcone S, Tonello C, Cozzi V, Palomba L, Fiorani M, Pisconti A, Brunelli S, Cardile A, Francolini M, Cantoni O, Carruba MO, Moncada S, Clementi E. Mitochondrial biogenesis by NO yields functionally active mitochondria in mammals. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16507-12. doi: 10.1073/pnas.0405432101. Epub 2004 Nov 15.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminoacid supplementation in people with Obesity Morbid and Weight Loss, run by Istituto Auxologico Italiano at 1 site in Italy.
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 1 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 31 Mar 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 Italy. 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?
Contact Amelia Brunani, MD (390323514232, brunani@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: At baseline and at 2 weeks after start of intervention). 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 NCT06309563, 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 31 Mar 2026.