Effect of a bean extract on glucose metabolism in obesity

In vivo effects of chronic administration of a Phaseolus vulgaris extract, containing alpha-amylase inhibitor and agglutinin, on glucometabolic status and the hunger-satiety circuit in subjects with severe obesity

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67373128

Enrollment

208

Registered

2021-05-20

Start date

2021-04-15

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycometabolic control in patients with severe obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

Randomization: Block randomisation at https://www.sealedenvelope.com/. The population will be divided into two arms: to avoid any kind of bias the two arms will be com

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Obesity (BMI =35 kg/m²) with or without comorbidities 2. 18 to 65 years of age 3. Dysglycemia, altered fasting glycemia or insulin resistance (HOMA index >2.5) 4. Possibility to be followed in the follow up at Auxologico Via Ariosto (Milan) 5. Negative swab for COVID-19 at enlistment

Exclusion criteria

Exclusion criteria: 1. Type 1 and 2 diabetes in treatment 2. Previous operations of bariatric surgery 3. Psychiatric illness 4. Inflammatory bowel disease 5. Untreated thyroid 6. Past or present history of malignant neoplasia

Design outcomes

Primary

Measure	Time frame
1. Insulin resistance measured using the HOMA Index before and after P.V. extract or placebo treatment at baseline (T0), after 2 weeks (T1), 4 weeks (T2) and after 12 weeks (T6) 2. Serum concentrations of glycated haemoglobin, glucose and insulin measured from blood samples taken before P.V. extract or placebo intake, baseline (T0), after 2 weeks (T1), 4 weeks (T2) and 12 weeks (T6) from the start of treatment	—

Measure

Time frame

1. Insulin resistance measured using the HOMA Index before and after P.V. extract or placebo treatment at baseline (T0), after 2 weeks (T1), 4 weeks (T2) and after 12 weeks (T6) 2. Serum concentrations of glycated haemoglobin, glucose and insulin measured from blood samples taken before P.V. extract or placebo intake, baseline (T0), after 2 weeks (T1), 4 weeks (T2) and 12 weeks (T6) from the start of treatment

—

Secondary

Measure	Time frame
The following outcomes are measured before and after the P.V. extract or placebo treatment at specific time points: before P.V. extract/placebo intake (T0) and after 2 weeks (T1), 4 weeks (T2), 8 weeks (T4) and 12 weeks (T6): 1. Weight and waist circumference measured to the nearest 0.1 kg and 0.1 cm, respectively. Waist circumference will be measured midway to the lowest rib and the top of the iliac crest after gentle expiration; weight will be measured with a digital scale. The anthropometric data will be expressed as the mean of two measurements. 2. Satiation and satiety assessed using the Visual Analogue Scale questionnaire 3. Collection of faecal samples at baseline and after 2 weeks, 4 weeks and 12 weeks for: 3.1. Gut microbiota composition defined by 16S rRNA gene profiling on DNA extracted 3.2. Characteristics of the stool identified through the Bristol Stool Scale (BSS) 3.3. Short-chain fatty acids identified in faecal samples through qualitative and quantitative analysis in gas chromatography and pH measuring 3.4. Intestinal permeability and inflammatory processes investigated through the dosage of serum zonulin and faecal calprotectin through the ELISA test	—

Measure

Time frame

The following outcomes are measured before and after the P.V. extract or placebo treatment at specific time points: before P.V. extract/placebo intake (T0) and after 2 weeks (T1), 4 weeks (T2), 8 weeks (T4) and 12 weeks (T6): 1. Weight and waist circumference measured to the nearest 0.1 kg and 0.1 cm, respectively. Waist circumference will be measured midway to the lowest rib and the top of the iliac crest after gentle expiration; weight will be measured with a digital scale. The anthropometric data will be expressed as the mean of two measurements. 2. Satiation and satiety assessed using the Visual Analogue Scale questionnaire 3. Collection of faecal samples at baseline and after 2 weeks, 4 weeks and 12 weeks for: 3.1. Gut microbiota composition defined by 16S rRNA gene profiling on DNA extracted 3.2. Characteristics of the stool identified through the Bristol Stool Scale (BSS) 3.3. Short-chain fatty acids identified in faecal samples through qualitative and quantitative analysis in gas chromatography and pH measuring 3.4. Intestinal permeability and inflammatory processes investigated through the dosage of serum zonulin and faecal calprotectin through the ELISA test

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026