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Recruiting NCT06193577

Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters

No phase Interventional Weight Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phaseolus Vulgaris L. Dry Extract, Placebo.
Who it may be relevant to
Registry conditions: Weight Loss. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Dietary supplement Phaseolus Vulgaris L. Dry Extract
    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.
  • Dietary supplement Placebo
    The placebo control does not contain active ingredients.

Primary outcome measures

  • Change in weight [Time frame: 0, 12 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • A.O.U. Policlinico "G. Rodolico - San Marco" — Catania

Identifiers

NCT: NCT06193577 · IBSA-PHAS-0122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗