Overweight and ObesityNCT06795607
Effect of the Probiotic SF68® on Body Composition and Low-to-moderate Cardiovascular Risk
A study testing Probiotic in people with Overweight and Obesity, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Obesity is a multifactorial disorder of energy balance, characterized by an imbalance between energy intake and energy consumption. In recent decades, the prevalence of obesity has reached epidemic proportions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2024to 31 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity (BMI >30 kg/m^2, class I, II, III) and overweight (BMI 25-29.9 kg/ m^2) and concomitant presence of at least one of the following risk factors detected by hematologic examinations performed within 1 year of the baseline screening visit:
- Circulating levels of total cholesterol >190 mg/dL, not on drug treatment
- Circulating levels of LDL cholesterol >115 mg/dL, not on drug treatment
- Circulating levels of triglycerides >150 mg/dL, not on drug treatment
- Ability and willingness to cooperate during the study, adhere to the procedures stipulated in the protocol and comply with its requirements.
- Ability and willingness to complete questionnaires required by the study and to complete all medical examinations required by the protocol.
Show all 10Show fewer
- Willingness to discontinue the consumption of functional foods and dietary supplements with probiotics, laxatives and body weight control substances starting 15 days before the screening view and until the conclusion of the study.
- Willingness to maintain a healthy and balanced lifestyle for the duration of the study.
- If female subject of childbearing age, must have a negative urine pregnancy test at screening and agree to use a reliable method of contraception throughout the study
- Ability to provide written informed consent.
Who cannot join
- Use of probiotics continuously, in the two months prior to the start of the study
- Use of other treatments (medications or nutritional programs) that affect body weight or dyslipidemia, gut microbiota, food intake, and/or energy expenditure (e.g., Statins and Fibrates)
- Antibiotic use
- Weight loss or gain > 5 kg in the 3 months prior to the start of the study.
- Pregnant or lactating women and women of childbearing age unwilling to use an adequate contraceptive method and take a pregnancy test at screening.
- Concurrent enrollment in another or similar obesity treatment program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic Formulation Based on SF68® on Body Composition and Low-to-moderate Cardiovascular Risk
Obesity is a multifactorial disorder of energy balance, characterized by an imbalance between energy intake and energy consumption. In recent decades, the prevalence of obesity has reached epidemic proportions. Advances in scientific research have enabled better characterization of the etiology of obesity, highlighting the potential contribution of factors not traditionally considered to be involved in changes in energy balance and body composition, such as the gut microbiota. Oral administration of probiotics has been proposed as a valid way to modulate the gut ecosystem to promote weight reduction. Preliminary data from a preclinical study in mouse models suggest that the dietary supplement SF68® containing the probiotic Enterococcus lactis as well as phytosterols and (6S)-5-methyltetrahydrofolic acid has the ability to significantly counteract weight gain. In addition to modulating the composition of the gut microbiota, it also has an impact on decreasing the levels of total cholesterol, low-density cholesterol (LDL), triglycerides, homocysteine, IL-1 β and LPS Binding Protein (LBP). Although exercise and diet are the first lines of intervention to be recommended, there are often failures or poor results. There is currently increased interest in alternative and effective shorter-term, non-pharmacological approaches to weight control that involve the use of natural active ingredients. Thus, the aim of this intervention study is to investigate whether a supplementation with SF68® could be beneficial for the weight reduction and the improvement of cardiovascular risk profile of people with overweight or obesity.
- Conditions
- Overweight and Obesity
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental product is a dietary supplement manufactured by Cerbios-Pharma S.A, Each stick contains probiotic live cultures of Enterococcus lactis SF68® at a concentration of 10^9 CFU, phytosterols, 6S-5MeTHF, maltose and silicon dioxide. Study participants will be given N°3 packs each containing 30 stick packs of 1.7 g each, in granulated form in sufficient quantity for the entire duration of the study (12 weeks). Subjects will be required to consume N°1 stick pack of the supplement daily after dinner for 12 continuous weeks. The product should be placed directly on the tongue and should be taken without water. After taking the product, the subject should drink half a glass of water to promote solubilization and transit. The supplement should be stored in a cool, dry place, away from light, moisture and direct heat sources to ensure the viability of the probiotic strain until the expiration date.
PlaceboDietary supplement
N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic food supplement produced by Cerbios-Pharma SA Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo food supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Changes of waist circumference from baseline assessed through a metric tape
Measured: 12 weeks
Secondary outcomes (33)
Gut microbiota
Changes of gut microbiota from baseline assessed by NGS technology
Measured: 12 weeks
Short-chain fatty acids (SCFAs)
Changes of SCFAs from baseline assessed by gas chromatography
Measured: 12 weeks
Hemoglobin
Changes of hemoglobin from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
White blood cells
Changes of white blood cells from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Red blood cells
Changes of red blood cells from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Platelets
Changes of platelets from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Glucose
Changes of glucose from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Insulin
Changes of insulin from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Glycated hemoglobin
Changes of glycated hemoglobin from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
HOMA index
Changes of HOMA index from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Total cholesterol
Changes of total cholesterol from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
LDL cholesterol
Changes of LDL cholesterol from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
HDL cholesterol
Changes of HDL cholesterol from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Triglycerides
Changes of triglycerides from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
AST
Changes of AST from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
ALT
Changes of ALT from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
GGT
Changes of GGT from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
hs-CRP
Changes of hs-CRP from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Interleukin 1-alpha
Changes of interleukin 1-alpha from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Interleukin 1-beta
Changes of interleukin 1-beta from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Interleukin 6
Changes of interleukin 6 from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Interleukin 18
Changes of interleukin 18 from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Tumor necrosis factor alpha
Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Reactive Oxigen Species (ROS)
Changes of Reactive Oxigen Species (ROS) from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Glutathione
Changes of glutathione from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Homocysteine
Changes of homocysteine from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
LPS-binding protein
Changes of LPS-binding protein from baseline assessed to standard laboratory procedures.
Measured: 12 weeks
Weight
Changes of body weight from baseline assessed through a balance.
Measured: 12 weeks
Fat mass
Changes of fat mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
Measured: 12 weeks
Fat-free mass
Changes of fat-free mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
Measured: 12 weeks
Dietary habits
Changes of dietary habits from baseline assessed through the Medi-Lite score, with a total score ranging from 0 to 18, with higher scores meaning a higher adherence to the Mediterranean diet.
Measured: 12 weeks
Gastrointestinal and systemic symptoms through the GAI score
Changes of gastrointestinal and systemic symptoms from baseline assessed through the Global Assessment of Improvement Scale (GAI), with a total score ranging from 0 to 56, with higher scores meaning an improvement of the symptoms
Measured: 12 weeks
Gastrointestinal and systemic symptoms through the SSS score
Changes of gastrointestinal and systemic symptoms from baseline assessed through the Symptom Severity Scale (SSS), with a total score ranging from 0 to 500, with higher scores meaning more severe symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start20 Feb 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Francesco Sofi, Prof., Principal investigator, Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795607
- Sponsor's protocol ID
- PrOBesity study
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borgeraas H, Johnson LK, Skattebu J, Hertel JK, Hjelmesaeth J. Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2018 Feb;19(2):219-232. doi: 10.1111/obr.12626. Epub 2017 Oct 18.
PubMed 29047207Chung HJ, Yu JG, Lee IA, Liu MJ, Shen YF, Sharma SP, Jamal MA, Yoo JH, Kim HJ, Hong ST. Intestinal removal of free fatty acids from hosts by Lactobacilli for the treatment of obesity. FEBS Open Bio. 2016 Jan 18;6(1):64-76. doi: 10.1002/2211-5463.12024. eCollection 2016 Jan.
PubMed 27047743Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
PubMed 32887946Gomes AC, de Sousa RG, Botelho PB, Gomes TL, Prada PO, Mota JF. The additional effects of a probiotic mix on abdominal adiposity and antioxidant Status: A double-blind, randomized trial. Obesity (Silver Spring). 2017 Jan;25(1):30-38. doi: 10.1002/oby.21671.
PubMed 28008750Holzapfel W, Arini A, Aeschbacher M, Coppolecchia R, Pot B. Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics. Benef Microbes. 2018 Apr 25;9(3):375-388. doi: 10.3920/BM2017.0148. Epub 2018 Apr 10.
PubMed 29633645Pagliai G, Baldi S, Tristan Asensi M, Giangrandi I, Lotti S, Bertelli A, Cei F, Bertorello S, Bartolucci G, Borghi S, Amedei A, Becatti M, Fiorillo C, Gori AM, Marcucci R, Colombini B, Sofi F. Effects of a Probiotic Formulation Based on SF68, Phytosterols, and 6S-5-Methyltetrahydrofolic Acid on Body Composition, Biochemical Parameters, Gut Microbiota, and Gastrointestinal and General Symptoms of Overweight/Obese Subjects: The PrObesity Study. Mol Nutr Food Res. 2025 Nov;69(21):e70198. doi: 10.1002/mnfr.70198. Epub 2025 Sep 18.
PubMed 40965226
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic Formulation Based on SF68® on Body Composition and Low-to-moderate Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT06795607
- Acronym / sponsor ID
- PrOBesity study
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jan 2025 (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.
Obesity is a multifactorial disorder of energy balance, characterized by an imbalance between energy intake and energy consumption. In recent decades, the prevalence of obesity has reached epidemic proportions. Advances in scientific research have enabled better characterization of the etiology of obesity, highlighting the potential contribution of factors not traditionally considered to be involved in changes in energy balance and body composition, such as the gut microbiota. Oral administration of probiotics has been proposed as a valid way to modulate the gut ecosystem to promote weight reduction. Preliminary data from a preclinical study in mouse models suggest that the dietary supplement SF68® containing the probiotic Enterococcus lactis as well as phytosterols and (6S)-5-methyltetrahydrofolic acid has the ability to significantly counteract weight gain. In addition to modulating the composition of the gut microbiota, it also has an impact on decreasing the levels of total cholesterol, low-density cholesterol (LDL), triglycerides, homocysteine, IL-1 β and LPS Binding Protein (LBP). Although exercise and diet are the first lines of intervention to be recommended, there are often failures or poor results. There is currently increased interest in alternative and effective shorter-term, non-pharmacological approaches to weight control that involve the use of natural active ingredients. Thus, the aim of this intervention study is to investigate whether a supplementation with SF68® could be beneficial for the weight reduction and the improvement of cardiovascular risk profile of people with overweight or obesity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticProbiotic food supplement produced by Cerbios-Pharma SA |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo food supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Obesity (BMI >30 kg/m^2, class I, II, III) and overweight (BMI 25-29.9 kg/ m^2) and concomitant presence of at least one of the following risk factors detected by hematologic examinations performed within 1 year of the baseline screening visit:
- Ability and willingness to cooperate during the study, adhere to the procedures stipulated in the protocol and comply with its requirements.
- Ability and willingness to complete questionnaires required by the study and to complete all medical examinations required by the protocol.
- Willingness to discontinue the consumption of functional foods and dietary supplements with probiotics, laxatives and body weight control substances starting 15 days before the screening view and until the conclusion of the study.
- Willingness to maintain a healthy and balanced lifestyle for the duration of the study.
Key exclusion criteria (6 listed)
- Use of probiotics continuously, in the two months prior to the start of the study
- Use of other treatments (medications or nutritional programs) that affect body weight or dyslipidemia, gut microbiota, food intake, and/or energy expenditure (e.g., Statins and Fibrates)
- Antibiotic use
- Weight loss or gain > 5 kg in the 3 months prior to the start of the study.
- Pregnant or lactating women and women of childbearing age unwilling to use an adequate contraceptive method and take a pregnancy test at screening.
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 |
|---|---|---|
| ProbioticThe experimental product is a dietary supplement manufactured by Cerbios-Pharma S.A, Each stick contains probiotic live cultures of Enterococcus lactis SF68® at a concentration of 10^9 CFU, phytosterols, 6S-5MeTHF, maltose and silicon dioxide. Study participants will be given N°3 packs each containing 30 stick packs of 1.7 g each, in granulated form in sufficient quantity for the entire duration of the study (12 weeks). Subjects will be required to consume N°1 stick pack of the supplement daily after dinner for 12 continuous weeks. The product should be placed directly on the tongue and should be taken without water. After taking the product, the subject should drink half a glass of water to promote solubilization and transit. The supplement should be stored in a cool, dry place, away from light, moisture and direct heat sources to ensure the viability of the probiotic strain until the expiration date. | Dietary supplement | Probiotic |
| PlaceboN°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic. | Dietary supplement | Placebo |
Primary outcome
Waist circumference
Time frame: 12 weeks
Changes of waist circumference from baseline assessed through a metric tape
33 secondary outcomes
Gut microbiota
Time frame: 12 weeks
Short-chain fatty acids (SCFAs)
Time frame: 12 weeks
Hemoglobin
Time frame: 12 weeks
White blood cells
Time frame: 12 weeks
Red blood cells
Time frame: 12 weeks
Platelets
Time frame: 12 weeks
Glucose
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
Glycated hemoglobin
Time frame: 12 weeks
HOMA index
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
LDL cholesterol
Time frame: 12 weeks
HDL cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
AST
Time frame: 12 weeks
ALT
Time frame: 12 weeks
GGT
Time frame: 12 weeks
hs-CRP
Time frame: 12 weeks
Interleukin 1-alpha
Time frame: 12 weeks
Interleukin 1-beta
Time frame: 12 weeks
Interleukin 6
Time frame: 12 weeks
Interleukin 18
Time frame: 12 weeks
Tumor necrosis factor alpha
Time frame: 12 weeks
Reactive Oxigen Species (ROS)
Time frame: 12 weeks
Glutathione
Time frame: 12 weeks
Homocysteine
Time frame: 12 weeks
LPS-binding protein
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Fat mass
Time frame: 12 weeks
Fat-free mass
Time frame: 12 weeks
Dietary habits
Time frame: 12 weeks
Gastrointestinal and systemic symptoms through the GAI score
Time frame: 12 weeks
Gastrointestinal and systemic symptoms through the SSS score
Time frame: 12 weeks
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 28 Jan 2025.
- Background: PubMed 29047207Borgeraas H, Johnson LK, Skattebu J, Hertel JK, Hjelmesaeth J. Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2018 Feb;19(2):219-232. doi: 10.1111/obr.12626. Epub 2017 Oct 18.
- Background: PubMed 27047743Chung HJ, Yu JG, Lee IA, Liu MJ, Shen YF, Sharma SP, Jamal MA, Yoo JH, Kim HJ, Hong ST. Intestinal removal of free fatty acids from hosts by Lactobacilli for the treatment of obesity. FEBS Open Bio. 2016 Jan 18;6(1):64-76. doi: 10.1002/2211-5463.12024. eCollection 2016 Jan.
- Background: PubMed 32887946Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
- Background: PubMed 28008750Gomes AC, de Sousa RG, Botelho PB, Gomes TL, Prada PO, Mota JF. The additional effects of a probiotic mix on abdominal adiposity and antioxidant Status: A double-blind, randomized trial. Obesity (Silver Spring). 2017 Jan;25(1):30-38. doi: 10.1002/oby.21671.
- Background: PubMed 29633645Holzapfel W, Arini A, Aeschbacher M, Coppolecchia R, Pot B. Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics. Benef Microbes. 2018 Apr 25;9(3):375-388. doi: 10.3920/BM2017.0148. Epub 2018 Apr 10.
- Derived from this study: PubMed 40965226Pagliai G, Baldi S, Tristan Asensi M, Giangrandi I, Lotti S, Bertelli A, Cei F, Bertorello S, Bartolucci G, Borghi S, Amedei A, Becatti M, Fiorillo C, Gori AM, Marcucci R, Colombini B, Sofi F. Effects of a Probiotic Formulation Based on SF68, Phytosterols, and 6S-5-Methyltetrahydrofolic Acid on Body Composition, Biochemical Parameters, Gut Microbiota, and Gastrointestinal and General Symptoms of Overweight/Obese Subjects: The PrObesity Study. Mol Nutr Food Res. 2025 Nov;69(21):e70198. doi: 10.1002/mnfr.70198. Epub 2025 Sep 18.
- 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.
Francesco Sofi, Prof. principal investigator
Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Overweight and Obesity, run by Azienda Ospedaliero-Universitaria Careggi 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 10 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: finished, as of the sponsor's last update on 28 Jan 2025. 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?
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?
Waist circumference (time frame: 12 weeks). 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 NCT06795607, which also lists 6 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 28 Jan 2025.