Effect of a bean extract on glucose metabolism in obesity
| ISRCTN | ISRCTN67373128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67373128 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2021_01_26_10 |
| Sponsor | Istituto Auxologico Italiano |
| Funders | Istituto Auxologico Italiano, Regione Lombardia, Indena |
- Submission date
- 07/04/2021
- Registration date
- 20/05/2021
- Last edited
- 20/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Among the treatment options for obesity, diet plays a central role. Some foods derived from plants have shown activity in controlling blood glucose after a meal. These compounds are contained in some food supplements such as those based on extracts from common beans. It is demonstrated that this extract reduces the absorption of sugar, leading to an improved blood glucose level in normal weight and overweight people. The aim of this study is to evaluate the medium- to long-term effects of the administration of bean extracts on the capability of insulin to carry out its action in a group of people with severe obesity, compared with a group with similar characteristics treated with a placebo (dummy). The study also aims to evaluate the effects of the extract on food intake.
Who can participate?
People aged between 18 and 65 with a Body Mass Index greater than or equal to 35 kg/m² with altered blood sugar but without type 1 or type 2 diabetes
What does the study involve?
Participants will be randomly allocated into two groups. One group will be given a 100 mg dose of P.V. extract 15-30 minutes before lunch and dinner (total daily dose 200 mg) for a period of 12 weeks, while the control group will be given a placebo (dummy). Both groups follow a balanced low-calorie diet: 50% carbohydrates, 20% protein and 30% fat. Each participant will undergo a nutritional assessment and are assigned a low-calorie diet calculated according to his/her energy requirements (with comparable energy reduction for all participants). Participants will also be asked to perform moderate aerobic physical activity.
What are the possible benefits and risks of participating?
The use of bean extract could help people to control blood sugar levels and, in the long term, lead to improved weight loss. To date, no undesirable effects have been observed; chronic use may lead to digestive symptoms such as bloating or flatulence. These effects will be monitored during the study.
Where does the study run from?
Istituto Auxologico Italiano (Italy)
When is the study starting and how long is it expected to run for?
December 2020 to October 2022
Who is funding the study?
1. Regione Lombardia (Italy)
2. Istituto Auxologico Italiano (Italy)
3. Indena (Italy)
Who is the main contact?
Prof. Massimo Scacchi, massimo.scacchi@unimi.it
Prof. ssa Simona Bertoli, simona.bertoli@unimi.it
Contact information
Scientific
via Cadorna 90
Oggebbio
28824
Italy
| Phone | +39 (0)323514301 |
|---|---|
| massimo.scacchi@unimi.it |
Scientific
Via Ariosto 13
Milan
20145
Italy
| Phone | +39 (0)250316653 |
|---|---|
| simona.bertoli@unimi.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized placebo-controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | MFHBB |
| Study objectives | Derangements of glucose metabolism, in particular pre-diabetic conditions, are among the most common comorbidities of severe obesity. The use of plant extracts such as Phaseolus vulgaris (P.V.), containing a glycoprotein able to inhibit pancreatic alpha-amylase and thus decrease intestinal absorption of complex carbohydrates, may be effective in these clinical conditions. In addition, Phaseolus extract contains agglutinins which have been shown to modulate the hunger-satiety circuit. The researchers hypothesize that supplementation with a standardized extract of P.V. could improve and modulate the glucometabolic profile compared to diet treatment alone in subjects suffering from severe obesity |
| Ethics approval(s) | Approved 26/01/2021, Ethics Committee Istituto Auxologico Italiano IRCCS (Via Ariosto 13, 20145, Milan, Italy; +39 (0)02619112237; comitato.etico@auxologico.it), ref: 2021_01_26_10 |
| Health condition(s) or problem(s) studied | Glycometabolic control in patients with severe obesity |
| Intervention | 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 comparable by age, gender and initial weight. One group will be given a 100 mg dose of P.V. extract 15-30 minutes before lunch and dinner for a period of 12 weeks, while the control group will be given a placebo identical in terms of excipient content with the exclusion of the active ingredient. Statistical analysis plan: Data will be reported as mean and standard deviation (SD) for continuous and normally distributed variables (median and interquartile range for non-normally distributed variables) and as absolute and relative frequency for categorical variables. The data from the experiment will be analysed using a repeated-measures ANOVA model by including the period effect, the treatment effect and the interaction between the two in the model. The variance-covariance matrix considered will be of the compound-symmetry type with a constant correlation between times. A sensitivity analysis will be conducted to assess the robustness of the results to changes in the structure of the variance-covariance matrix. Sample size: A sample size of 208 subjects, 104 for each arm in the study, will reach a power of 80% in detecting a statistically significant difference of 0.7 between the start and end of treatment in the experimental group and between the start and end of treatment in the placebo group assuming a significance level of 5%. This sample size was calculated by considering a standard deviation of 2 of the differences between the start and end of treatment between the two groups. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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): |
| Completion date | 15/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 208 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/04/2021 |
| Date of final enrolment | 15/04/2022 |
Locations
Countries of recruitment
- Italy
Study participating centres
Oggebbio
28824
Italy
Milano
20145
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Sara Mambrini (s.mambrini@auxologico.it), a.bruno@auxologico.it; Simona Bertoli (simona.bertoli@unimi.it), Massimo Scacchi (massimo.scacchi@unimi.it). Data of the markers analysed will be available upon request at the end of the study. Data are anonymous and consent from participants was obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2021: Internal review.
16/04/2021: Trial's existence confirmed by the ethics committee of Istituto Auxologico Italiano.
