Sarcopenic ObesitySARCONCT05143398
Nutritional Supplementation in Sarcopenic Obesity
A study testing Diet + protein, Diet + EAA and Diet + EAA and TCA in people with Sarcopenic Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in… Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Diet + protein, Diet + EAA and Diet + EAA and TCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 10 Mar 2021
- Phase
- Interventional
- 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 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with obesity (BMI> 35kg / m2)
- sarcopenia (criteria described in Coltorti A et al).
Who cannot join
- renal insufficiency
- diabetes
- muscular pathologies
- neurological-neurodegenerative pathologies
- cognitive decline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Rehabilitation Program (Nutritional + Physical Activity) in Sarcopenic Obesity
The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.
Read the detailed description
Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO.
The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.
- Conditions
- Sarcopenic Obesity
- Being tested
- Diet + protein, Diet + EAA, Diet + EAA and TCA, Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet + proteinDietary supplement
Comparison of the efficacy
Diet + EAADietary supplement
Comparison of the efficacy
Diet + EAA and TCADietary supplement
Comparison of the efficacy
DietOther
Comparison of the efficacy
| Study group | Role | What they receive |
|---|---|---|
| Diet Arm | Active comparator | low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE) Receives: Other: Diet |
| Protein Arm | Active comparator | low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein) Receives: Dietary Supplement: Diet + protein |
| EAA Arm | Active comparator | low-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr). Receives: Dietary Supplement: Diet + EAA |
| EAA + TCA | Active comparator | low-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid) Receives: Dietary Supplement: Diet + EAA and TCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body weight
weight in kilograms
Measured: basal and at 4 weeks
Change of Height
height in meters
Measured: basal and at 4 weeks
Change of BMI
weight and height will be combined to report BMI in kg/m^2
Measured: basal and at 4 weeks
Change of Waist
waist circumference in centimeters
Measured: basal and at 4 weeks
Change of FM
Fat Mass (FM) in % of body weight in kilograms
Measured: basal and at 4 weeks
Change of FFM
Free Fat Mass (FFM) in % of body weight in kilograms
Measured: basal and at 4 weeks
Change of MM
Muscle Mass (MM) in % of body weight in kilograms
Measured: basal and at 4 weeks
Change of Muscle strenght
muscle streght at the hand (right and left) in kg
Measured: basal and at 4 weeks
Change of Walking
6 minute walk test (6MWT), meters walking in 6 minutes
Measured: basal and at 4 weeks
Change of TUG
time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down
Measured: basal and at 4 weeks
Change of Metabolic profile
glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl
Measured: basal and at 4 weeks
Change of Insulin secretion
insulin pasma levels in mU/l
Measured: basal and at 4 weeks
Change of Homa index
glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l
Measured: basal and at 4 weeks
Change of Muscle function
irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml
Measured: basal and at 4 weeks
Change of Muscle wasting
C-terminal agrin fragment (CAF) in pg/ml
Measured: basal and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Sep 2018
- Primary completion15 Oct 2020
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After 1 week of standard diet (1650kcal/day with 18% protein) without physical activity, patients will be randomized into one of the 4 arms described below (20 subjects per study arm): 1st arm: low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE); 2nd arm: low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein; 3rd diet: low-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr). 4th diet: low-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid). All patients perform daily aerobic physical activity/5 days/week for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Brunani, Istituto Auxologico Italiano
- Investigators
- Amelia Brunani, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143398
- Sponsor's protocol ID
- 2018_06_28_05
- Acronym
- SARCO
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu KJ, Liao CD, Tsai MW, Chen CN. Effects of Exercise and Nutritional Intervention on Body Composition, Metabolic Health, and Physical Performance in Adults with Sarcopenic Obesity: A Meta-Analysis. Nutrients. 2019 Sep 9;11(9):2163. doi: 10.3390/nu11092163.
PubMed 31505890Wang X, Miller GD, Messier SP, Nicklas BJ. Knee strength maintained despite loss of lean body mass during weight loss in older obese adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):866-71. doi: 10.1093/gerona/62.8.866.
PubMed 17702878Frimel TN, Sinacore DR, Villareal DT. Exercise attenuates the weight-loss-induced reduction in muscle mass in frail obese older adults. Med Sci Sports Exerc. 2008 Jul;40(7):1213-9. doi: 10.1249/MSS.0b013e31816a85ce.
PubMed 18580399Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22.
PubMed 28539168Rondanelli M, Opizzi A, Antoniello N, Boschi F, Iadarola P, Pasini E, Aquilani R, Dioguardi FS. Effect of essential amino acid supplementation on quality of life, amino acid profile and strength in institutionalized elderly patients. Clin Nutr. 2011 Oct;30(5):571-7. doi: 10.1016/j.clnu.2011.04.005. Epub 2011 Jun 1.
PubMed 21636183D'Antona G, Ragni M, Cardile A, Tedesco L, Dossena M, Bruttini F, Caliaro F, Corsetti G, Bottinelli R, Carruba MO, Valerio A, Nisoli E. Branched-chain amino acid supplementation promotes survival and supports cardiac and skeletal muscle mitochondrial biogenesis in middle-aged mice. Cell Metab. 2010 Oct 6;12(4):362-372. doi: 10.1016/j.cmet.2010.08.016.
PubMed 20889128Solerte SB, Gazzaruso C, Bonacasa R, Rondanelli M, Zamboni M, Basso C, Locatelli E, Schifino N, Giustina A, Fioravanti M. Nutritional supplements with oral amino acid mixtures increases whole-body lean mass and insulin sensitivity in elderly subjects with sarcopenia. Am J Cardiol. 2008 Jun 2;101(11A):69E-77E. doi: 10.1016/j.amjcard.2008.03.004.
PubMed 18514630Valerio A, D'Antona G, Nisoli E. Branched-chain amino acids, mitochondrial biogenesis, and healthspan: an evolutionary perspective. Aging (Albany NY). 2011 May;3(5):464-78. doi: 10.18632/aging.100322.
PubMed 21566257Coltorti A, Scalfi L, Borrelli R, Contaldo F, Diaz E. [Validity of 5 bioelectric impedance equations for the estimation of lean body mass in women]. Minerva Endocrinol. 1991 Jan-Mar;16(1):37-41. Italian.
PubMed 1944015Brunani A, Cancello R, Gobbi M, Lucchetti E, Di Guglielmo G, Maestrini S, Cattaldo S, Pitera P, Ruocco C, Milesi A, Valerio A, Capodaglio P, Nisoli E. Comparison of Protein- or Amino Acid-Based Supplements in the Rehabilitation of Men with Severe Obesity: A Randomized Controlled Pilot Study. J Clin Med. 2023 Jun 25;12(13):4257. doi: 10.3390/jcm12134257.
PubMed 37445292
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Rehabilitation Program (Nutritional + Physical Activity) in Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT05143398
- Acronym / sponsor ID
- SARCO / 2018_06_28_05
- Conditions
- Sarcopenic Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 3 Dec 2021 (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 obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.
Detailed description
Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO.
The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After 1 week of standard diet (1650kcal/day with 18% protein) without physical activity, patients will be randomized into one of the 4 arms described below (20 subjects per study arm): 1st arm: low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE); 2nd arm: low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein; 3rd diet: low-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr). 4th diet: low-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid). All patients perform daily aerobic physical activity/5 days/week for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Diet Arm | Active comparator | Other: Dietlow-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE) |
| Protein Arm | Active comparator | Dietary Supplement: Diet + proteinlow-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein) |
| EAA Arm | Active comparator | Dietary Supplement: Diet + EAAlow-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr). |
| EAA + TCA | Active comparator | Dietary Supplement: Diet + EAA and TCAlow-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with obesity (BMI> 35kg / m2)
- sarcopenia (criteria described in Coltorti A et al).
Key exclusion criteria (5 listed)
- renal insufficiency
- diabetes
- muscular pathologies
- neurological-neurodegenerative pathologies
- cognitive decline
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 |
|---|---|---|
| Diet + proteinComparison of the efficacy | Dietary supplement | Protein Arm |
| Diet + EAAComparison of the efficacy | Dietary supplement | EAA Arm |
| Diet + EAA and TCAComparison of the efficacy | Dietary supplement | EAA + TCA |
| DietComparison of the efficacy | Other | Diet Arm |
Primary outcome
Change of Body weight
Time frame: basal and at 4 weeks
weight in kilograms
Change of Height
Time frame: basal and at 4 weeks
height in meters
Change of BMI
Time frame: basal and at 4 weeks
weight and height will be combined to report BMI in kg/m^2
Change of Waist
Time frame: basal and at 4 weeks
waist circumference in centimeters
Change of FM
Time frame: basal and at 4 weeks
Fat Mass (FM) in % of body weight in kilograms
Change of FFM
Time frame: basal and at 4 weeks
Free Fat Mass (FFM) in % of body weight in kilograms
Change of MM
Time frame: basal and at 4 weeks
Muscle Mass (MM) in % of body weight in kilograms
Change of Muscle strenght
Time frame: basal and at 4 weeks
muscle streght at the hand (right and left) in kg
Change of Walking
Time frame: basal and at 4 weeks
6 minute walk test (6MWT), meters walking in 6 minutes
Change of TUG
Time frame: basal and at 4 weeks
time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down
Change of Metabolic profile
Time frame: basal and at 4 weeks
glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl
Change of Insulin secretion
Time frame: basal and at 4 weeks
insulin pasma levels in mU/l
Change of Homa index
Time frame: basal and at 4 weeks
glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l
Change of Muscle function
Time frame: basal and at 4 weeks
irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml
Change of Muscle wasting
Time frame: basal and at 4 weeks
C-terminal agrin fragment (CAF) in pg/ml
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 3 Dec 2021.
- Background: PubMed 31505890Hsu KJ, Liao CD, Tsai MW, Chen CN. Effects of Exercise and Nutritional Intervention on Body Composition, Metabolic Health, and Physical Performance in Adults with Sarcopenic Obesity: A Meta-Analysis. Nutrients. 2019 Sep 9;11(9):2163. doi: 10.3390/nu11092163.
- Background: PubMed 17702878Wang X, Miller GD, Messier SP, Nicklas BJ. Knee strength maintained despite loss of lean body mass during weight loss in older obese adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):866-71. doi: 10.1093/gerona/62.8.866.
- Background: PubMed 18580399Frimel TN, Sinacore DR, Villareal DT. Exercise attenuates the weight-loss-induced reduction in muscle mass in frail obese older adults. Med Sci Sports Exerc. 2008 Jul;40(7):1213-9. doi: 10.1249/MSS.0b013e31816a85ce.
- Background: PubMed 28539168Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22.
- Background: PubMed 21636183Rondanelli M, Opizzi A, Antoniello N, Boschi F, Iadarola P, Pasini E, Aquilani R, Dioguardi FS. Effect of essential amino acid supplementation on quality of life, amino acid profile and strength in institutionalized elderly patients. Clin Nutr. 2011 Oct;30(5):571-7. doi: 10.1016/j.clnu.2011.04.005. Epub 2011 Jun 1.
- Background: PubMed 20889128D'Antona G, Ragni M, Cardile A, Tedesco L, Dossena M, Bruttini F, Caliaro F, Corsetti G, Bottinelli R, Carruba MO, Valerio A, Nisoli E. Branched-chain amino acid supplementation promotes survival and supports cardiac and skeletal muscle mitochondrial biogenesis in middle-aged mice. Cell Metab. 2010 Oct 6;12(4):362-372. doi: 10.1016/j.cmet.2010.08.016.
- Background: PubMed 18514630Solerte SB, Gazzaruso C, Bonacasa R, Rondanelli M, Zamboni M, Basso C, Locatelli E, Schifino N, Giustina A, Fioravanti M. Nutritional supplements with oral amino acid mixtures increases whole-body lean mass and insulin sensitivity in elderly subjects with sarcopenia. Am J Cardiol. 2008 Jun 2;101(11A):69E-77E. doi: 10.1016/j.amjcard.2008.03.004.
- Background: PubMed 21566257Valerio A, D'Antona G, Nisoli E. Branched-chain amino acids, mitochondrial biogenesis, and healthspan: an evolutionary perspective. Aging (Albany NY). 2011 May;3(5):464-78. doi: 10.18632/aging.100322.
- Background: PubMed 1944015Coltorti A, Scalfi L, Borrelli R, Contaldo F, Diaz E. [Validity of 5 bioelectric impedance equations for the estimation of lean body mass in women]. Minerva Endocrinol. 1991 Jan-Mar;16(1):37-41. Italian.
- Derived from this study: PubMed 37445292Brunani A, Cancello R, Gobbi M, Lucchetti E, Di Guglielmo G, Maestrini S, Cattaldo S, Pitera P, Ruocco C, Milesi A, Valerio A, Capodaglio P, Nisoli E. Comparison of Protein- or Amino Acid-Based Supplements in the Rehabilitation of Men with Severe Obesity: A Randomized Controlled Pilot Study. J Clin Med. 2023 Jun 25;12(13):4257. doi: 10.3390/jcm12134257.
- 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.
Amelia Brunani, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet + protein, Diet + EAA and Diet + EAA and TCA in people with Sarcopenic Obesity, 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 2 inclusion and 5 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 3 Dec 2021. 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. 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?
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?
Change of Body weight (time frame: basal and at 4 weeks). The study lists 15 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 NCT05143398, which also lists 10 linked publications.
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 3 Dec 2021.