Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)

NCT03230123 | Unknown

• 1 other identifier: BIO-123
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Pre-diabetes

Keywords

Diabetes Mellitus; green banana; resistant starch; glucose; prebiotics; insulin; incretins

Outcome Measures

Primary Outcomes (1)

• Percent reduction in glycated hemoglobin

  Percent reduction in glycated hemoglobin plasma levels will compare 6 months and baseline levels.

  6 months

Secondary Outcomes (1)

• Percent increase in GLP-1

  6 months

Study Arms (2)

Green banana biomass

EXPERIMENTAL

The intervention group is constituted diet counseling plus 4.5 g of resistant starch from green banana biomass, per day, during six months.

Dietary Supplement: Green banana biomass

Diet alone

PLACEBO COMPARATOR

The control group will receive diet counseling during six months.

Dietary Supplement: Green banana biomass

Interventions

Green banana biomass DIETARY_SUPPLEMENT

Green banana biomass will be suplemented to diet as 4.5 g per day.

Diet alone; Green banana biomass

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• AIDS
• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04039030, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Hyperinsulinism

Study Officials

• Maria C Izar, M.D., Ph.D.

  Federal University of Sao Paulp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria C Izar, M.D., Ph.D.

CONTACT

55-11-55764961; mcoizar@terra.com.br

Edna S Costa, N.D., M.Sc.

CONTACT

55-11-55764961; edna.costanutri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: Patients with diabetes and Pre-diabetes were randomly allocated to receive diet alone or diet plus green banana biomass suplementation during a six-month intervention period.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)