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

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ClinicalTrials.gov Identifier: NCT03230123
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Cristina de Oliveira Izar, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Pre-diabetes Dietary Supplement: Green banana biomass Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Green banana biomass
Green banana biomass will be suplemented to diet as 4.5 g per day.

Placebo Comparator: Diet alone
The control group will receive diet counseling during six months.
Dietary Supplement: Green banana biomass
Green banana biomass will be suplemented to diet as 4.5 g per day.




Primary Outcome Measures :
  1. Percent reduction in glycated hemoglobin [ Time Frame: 6 months ]
    Percent reduction in glycated hemoglobin plasma levels will compare 6 months and baseline levels.


Secondary Outcome Measures :
  1. Percent increase in GLP-1 [ Time Frame: 6 months ]
    Percent increase in GLP-1 plasma levels will compare 6 months and baseline levels.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230123


Contacts
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Contact: Maria C Izar, M.D., Ph.D. 55-11-55764961 ext 2501 mcoizar@terra.com.br
Contact: Edna S Costa, N.D., M.Sc. 55-11-55764961 ext 2506 edna.costanutri@gmail.com

Locations
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Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04039030
Contact: Maria C Izar, M.D.; Ph.D.    55-11-55499395    mcoizar@terra.com.br   
Contact: Francisco A Fonseca, M.D.; Ph.D.    55-11-55499395    fahfonseca@terra.com.br   
Principal Investigator: Maria C Izar, M.D.; Ph.D.         
Sub-Investigator: Edna S Costa, N.D.; M.Sc.         
Sub-Investigator: Francisco A Fonseca, M.D.; Ph.D.         
Sub-Investigator: Henrique T Bianco, M.D., Ph.D.         
Sub-Investigator: Juliana T Kato, N.D., M.Sc.         
Sub-Investigator: Thiago T Freitas, N.D., M.Sc.         
Sub-Investigator: Carolina N Franca, Ph.D.         
Sub-Investigator: Henrique A Fonseca, Ph.D.         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Maria C Izar, M.D., Ph.D. Federal University of Sao Paulp

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Responsible Party: Maria Cristina de Oliveira Izar, M.D., Ph.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03230123     History of Changes
Other Study ID Numbers: BIO-123
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maria Cristina de Oliveira Izar, Federal University of São Paulo:
Diabetes Mellitus
green banana
resistant starch
glucose
prebiotics
insulin
incretins

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia