Health TrialsbyHealthPanel

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

ConditionWeight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorIBSA Farmaceutici Italia Srl

About this trial

Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism

Diabetes mellitus

Smoking > 10 cigarettes/day

Alcohol > 2 alcohol units/day (equal to 24 g of ethanol)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phaseolus Vulgaris L. Dry Extract

    Dietary 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.

  • Placebo

    Dietary supplement

    The placebo control does not contain active ingredients.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Phaseolus Vulgaris L. Dry ExtractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in weight

Weight evaluation before and after treatment

Time frame
0, 12 weeks

Secondary outcomes

1

Change in weight

Weight evaluation before and after treatment

Time frame
0, 4, 8, 18 weeks
2

Change in Body Mass Index

BMI evaluation before and after treatment

Time frame
0, 4, 8, 12, 18 weeks
3

Change in glycemia

Glycemia evaluation before and after treatment

Time frame
0, 4, 8, 12, 18 weeks
4

Change in total testosterone levels

Total testosterone levels evaluation before and after treatment

Time frame
0, 4, 8, 12, 18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IBSA Farmaceutici Italia Srl

Lead sponsor

Informapro Srl

Collaborator

Universita degli Studi di Catania

Collaborator

Source ClinicalTrials.gov
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