Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Percent reduction in glycated hemoglobin
Study Overview
Brief Summary
Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo, 2015.
According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a heterogeneous group of metabolic disorders associated with microvascular complications, hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it is estimated that the world population with diabetes is 382 million people and it is expected to reach 471 million in 2035. About 80% of individuals with diabetes live in developing countries where the epidemic has greater intensity. In the Diabetes Control and Complications Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~ 7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as starch and products of its hydrolysis are not absorbed in the small intestine. The green banana presents significant levels of RS, and it is considered a source for the intake of this substance. These foods have physiological functions in the intestinal regulation in glycemic control and delayed gastric emptying. To our knowledge, there are no long-term studies with DM to prove the benefits of resistant starch use. The objective of this study is to assess the benefits of green banana biomass consumption by patients with Pre DM and DM. Considering the possibility of improving glucose, lipid profile, increasing the secretion of glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers IL-6, PCR.
Detailed Description
INTRODUCTION Cardiovascular Disease and Diabetes In Brazil, chronic non-communicable diseases (NCDs) were the cause of 72% of deaths and reached 63% in the world in 2008, with large numbers of premature deaths. Cardiovascular disease (31.3%), Diabetes Mellitus (DM) (5.2%), cancer (16.3%) and respiratory disease (5.8%) are the main causes of NCDs, leading to loss of quality of life, causing economic impacts that lead to increased poverty. These factors can be reversed through broad interventions and cost-effective health promotion. (Schmidt et al, 2011;. Malta et.al., 2011).
Currently, it is estimated that the world population with diabetes is 382 million people and it is expected to reach 471 million in 2035. About 80% of individuals with diabetes live in developing countries, where the epidemic has greater intensity, with increasing proportion of people affected in younger age groups, coexisting with the problem that infectious diseases still represent. (International Diabetes Federation, 2013; Brazilian Diabetes Society, 2015).
Brazilian data show in 2011 that DM mortality rates (per 100,000 inhabitants) is 30.1 for the general population, 27.2 in men and 32.9 in women, increasing significantly with advancing age, which varies from 0.50 for the age group among 0-29 years to 223.8 for individuals aged from 60 or more, ie an increase of 448 times. (Ministry of Health (USA), 2014; Brazilian Diabetes Society, 2015).
According to the Brazilian Society of Diabetes (2015), DM is a heterogeneous group of metabolic disorders associated to microvascular complications, hyperglycemia, resulting in a higher risk of developing cardiovascular disease (CVD), resulting from defects in insulin action, in insulin secretion or both.
The reference values for diagnosis of DM are glycated hemoglobin (HbA1c)> 6.5% being confirmed in another collecting and dispensable in case of symptoms or glucose> 200 mg and prediabetes HbA1c between 5.7% and 6 4% (Brazilian Society of Diabetes, 2015).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •having signed the written informed consent
- •males and females aging 18-85 years
- •glycated hemoglobin >= 6.5% for diabetic patients
- •glycated hemoglobin between 5.7% and 6.4% for pre-diabetic patients
- •on stable dose of anti-diabetic drugs and without antecipation of dosage changes during study protocol
Exclusion Criteria
- •use of insulin
- •those who need change in dose or addition of medication for diabetes
- •any malignancies, except basocelular carcinoma
- •heart failure with NYHA class III or IV
- •renal failure (GFR< 30 mL/min) or under dialysis therapy
- •uncontrolled hypothyroidism (TSH > 10 uUI/mL)
- •active liver disease
- •severe psychiatric disorders
- •any other disease that in the opinion of the investigator could interfere in the results
Arms & Interventions
Green banana biomass
The intervention group is constituted diet counseling plus 4.5 g of resistant starch from green banana biomass, per day, during six months.
Intervention: Green banana biomass (Dietary Supplement)
Diet alone
The control group will receive diet counseling during six months.
Intervention: Green banana biomass (Dietary Supplement)
Outcomes
Primary Outcomes
Percent reduction in glycated hemoglobin
Time Frame: 6 months
Percent reduction in glycated hemoglobin plasma levels will compare 6 months and baseline levels.
Secondary Outcomes
- Percent increase in GLP-1(6 months)
Investigators
Maria Cristina de Oliveira Izar
M.D., Ph.D.
Federal University of São Paulo