Weight LossNCT06193577
Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
A study testing Phaseolus Vulgaris L. Dry Extract in people with Weight Loss, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
Trial summary
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Weight Loss
- What is being tested?
- Phaseolus Vulgaris L. Dry Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 8 Nov 2023to 30 Jun 2025
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects aged between 18 and 60 years
- BMI between 25 and 35 kg/m2
- Habitual consumption of three main meals a day
- Stable body weight during the 3 months prior to enrollment
- Commitment to adhere to the diet and avoid the use of other weight loss products during the study
- Commitment not to change lifestyle significantly for the entire duration of the study.
- Signing of informed consent
Who cannot join
- Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism
- Diabetes mellitus
- Smoking > 10 cigarettes/day
- Alcohol > 2 alcohol units/day (equal to 24 g of ethanol)
- History of eating disorders during the 12 months prior to enrollment
- Use of any drug or product to treat obesity (e.g. meal replacements)
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- Presence of acute or chronic gastrointestinal diseases
- Active use of drugs that could influence the functions: gastrointestinal (e.g. laxatives, etc.), insulin (insulin sensitizers, etc.) and/or testicular (hormones, substances that influece testosterone production
- Known sensitivity to the ingredients of the preparation
- Any other clinical condition judged by the investigator to be incompatible with participation in the trial
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
A.O.U. Policlinico "G. Rodolico - San Marco"
Catania, Catania, 95123
Carmelo Gusmano, MD
About this study
Official title: Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
Read the detailed description
Monocentric, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract (test) on weight reduction and on metabolic parameters after 12 weeks of supplementation. The efficacy on weight reduction will be evaluated in comparison with the placebo group (control).
- Conditions
- Weight Loss
- Being tested
- Phaseolus Vulgaris L. Dry Extract, Placebo
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaseolus Vulgaris L. Dry ExtractDietary supplement
Extracts of Phaseolus vulgaris (beans) in association with a balanced diet are known to reduce glycaemia and food intake in rodents and humans thus promoting weight loss.
PlaceboDietary supplement
The placebo control does not contain active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Phaseolus Vulgaris L. Dry Extract | Experimental | Test Receives: Dietary Supplement: Phaseolus Vulgaris L. Dry Extract |
| Placebo | Placebo comparator | Control Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight evaluation before and after treatment
Measured: 0, 12 weeks
Secondary outcomes (18)
Change in weight
Weight evaluation before and after treatment
Measured: 0, 4, 8, 18 weeks
Change in Body Mass Index
BMI evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in glycemia
Glycemia evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in total testosterone levels
Total testosterone levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in LH levels
Luteinizing hormone (LH) levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in FSH levels
Follicle-stimulating hormone (FSH) levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in SHBG levels
Sex Hormone Binding Globulin (SHBG) levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in 17-beta-estradiol levels
17-beta-estradiol levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in insulin levels
Insulin levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in albumin levels
Albumin levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in carboxylated osteocalcin (cxOCN) levels
Carboxylated osteocalcin levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in uncarboxylated osteocalcin (ucOCN) levels
Uncarboxylated osteocalcin levels evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Change in calculated free testosterone (CFT) concentrations
Calculated free testosterone (CFT) concentrations evaluation before and after treatment
Measured: 0, 4, 8, 12, 18 weeks
Sperm count
Sperm count before and after treatment
Measured: 0, 12, 18 weeks
Sperm motility
Sperm motility before and after treatment
Measured: 0, 12, 18 weeks
Sperm morphology evaluation
Sperm morphology evaluation before and after treatment
Measured: 0, 12, 18 weeks
Sperm vitality
Sperm vitality evaluation before and after treatment
Measured: 0, 12, 18 weeks
Tunel test
Sperm DNA fragmentation evaluation
Measured: 0, 12, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start8 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Informapro Srl, University of Catania
- Responsible party
- Sponsor
- Investigators
- Aldo Calogero, Prof., Principal investigator, Università di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193577
- Sponsor's protocol ID
- IBSA-PHAS-0122
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
- ClinicalTrials.gov ID
- NCT06193577
- Acronym / sponsor ID
- IBSA-PHAS-0122
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Informapro Srl, University of Catania
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Jan 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.
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
Detailed description
Monocentric, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract (test) on weight reduction and on metabolic parameters after 12 weeks of supplementation. The efficacy on weight reduction will be evaluated in comparison with the placebo group (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Phaseolus Vulgaris L. Dry Extract | Experimental | Dietary Supplement: Phaseolus Vulgaris L. Dry ExtractTest |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboControl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male subjects aged between 18 and 60 years
- BMI between 25 and 35 kg/m2
- Habitual consumption of three main meals a day
- Stable body weight during the 3 months prior to enrollment
- Commitment to adhere to the diet and avoid the use of other weight loss products during the study
Key exclusion criteria (10 listed)
- Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism
- Diabetes mellitus
- Smoking > 10 cigarettes/day
- Alcohol > 2 alcohol units/day (equal to 24 g of ethanol)
- History of eating disorders during the 12 months prior to enrollment
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 |
|---|---|---|
| Phaseolus Vulgaris L. Dry ExtractExtracts of Phaseolus vulgaris (beans) in association with a balanced diet are known to reduce glycaemia and food intake in rodents and humans thus promoting weight loss. | Dietary supplement | Phaseolus Vulgaris L. Dry Extract |
| PlaceboThe placebo control does not contain active ingredients. | Dietary supplement | Placebo |
Primary outcome
Change in weight
Time frame: 0, 12 weeks
Weight evaluation before and after treatment
18 secondary outcomes
Change in weight
Time frame: 0, 4, 8, 18 weeks
Change in Body Mass Index
Time frame: 0, 4, 8, 12, 18 weeks
Change in glycemia
Time frame: 0, 4, 8, 12, 18 weeks
Change in total testosterone levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in LH levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in FSH levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in SHBG levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in 17-beta-estradiol levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in insulin levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in albumin levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in carboxylated osteocalcin (cxOCN) levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in uncarboxylated osteocalcin (ucOCN) levels
Time frame: 0, 4, 8, 12, 18 weeks
Change in calculated free testosterone (CFT) concentrations
Time frame: 0, 4, 8, 12, 18 weeks
Sperm count
Time frame: 0, 12, 18 weeks
Sperm motility
Time frame: 0, 12, 18 weeks
Sperm morphology evaluation
Time frame: 0, 12, 18 weeks
Sperm vitality
Time frame: 0, 12, 18 weeks
Tunel test
Time frame: 0, 12, 18 weeks
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 8 Jan 2025.
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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.
Aldo Calogero, Prof. principal investigator
Università di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaseolus Vulgaris L. Dry Extract in people with Weight Loss, run by IBSA Farmaceutici Italia Srl 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 7 inclusion and 10 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 8 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?
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 Carmelo Gusmano, MD (+393891136444, carmelo.gusmano@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 0, 12 weeks). 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 8 Jan 2025.