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Effect of Resistant Starch on Insulin Sensitivity and Beta Cell Function in Subjects With Prediabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294915
Recruitment Status : Unknown
Verified September 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Not yet recruiting
First Posted : September 27, 2017
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
To compare the use supplementation based on green banana flour versus placebo in the insulin sensitivity on individuals who have prediabetes.

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: Resistant Starch Dietary Supplement: Placebo Not Applicable

Detailed Description:

In order to evaluate whether supplementation with green banana flour may improve insulin sensitivity of individuals with prediabetes, volunteers will be recruited by advertising on the web page of Hospital de Clinical de Porto Alegre. After screening and selection, they will be submitted to a clinical, laboratory and nutritional standard evaluation, assessment of physical activity and body fat composition.The laboratory evaluation will include the oral glucose tolerance test (OGGT 75g), lipid profile, insulin, C-peptide, glycated hemoglobin and glycated albumin. Insulin sensitivity and beta-cell function will be assessed by the hyperglycemic CLAMP before and after the intervention.Interim statistical analysis will be performed at the end of the participation of ten study volunteers.

Subjects will receive green banana flour or placebo for four weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Resistant Starch From Green Banana Flour on the Insulin Sensitivity of Subjects With Prediabetes: Randomized Clinical Trial
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Prediabetes
Drug Information available for: Starch

Arm Intervention/treatment
Active Comparator: Resistant Starch
Green banana flour
Dietary Supplement: Resistant Starch
Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants

Placebo Comparator: Placebo
Maltodextrin, cellulose and guar gum
Dietary Supplement: Placebo
Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 4 weeks ]
    Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp


Secondary Outcome Measures :
  1. Hormonal changes [ Time Frame: 4 weeks ]
    Alteration of hormones that affect glucose metabolism, such as peptide C

  2. Change in lipid profile [ Time Frame: 4 weeks ]
    Alteration of total cholesterol, HDL-cholesterol and triglycerides

  3. Change total body fat [ Time Frame: 4 weeks ]
    Change total body fat will be compared before and after the intervention by means of bioimpedance

  4. Beta cell function [ Time Frame: 4 weeks ]
    Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp

  5. Glycemic control [ Time Frame: 4 weeks ]
    Measured by hemoglobin glycated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  1. Serum glycated hemoglobin (A1c) values between 5.7 and 6.5%, or fasting glucose ≥ 5.55 mmol/L and < 6.94 mmol/L or oral glucose tolerance test (75g) ≥7.77 and <11.04 mmol /L.
  2. Body mass index (BMI) ≥ 25 kg / m² (≥23 kg / m² for those of Asian origin) and ≤ 35 kg / m² for screening.
  3. Stable weight (maximum variation of approximately 5%) for at least 4 weeks prior to screening.
  4. Apt and willing to provide the written informed consent term and to comply with the requirements of the study protocol.

Exclusion Criteria:

  1. Clinically symptomatic gastrointestinal disease including, but not limited to, inflammatory bowel disease.
  2. History of gastric bypass, antrectomy, or resection of the small intestine.
  3. History of chronic pancreatitis or acute idiopathic pancreatitis.
  4. Myocardial infarction, coronary artery bypass grafting, post-transplant cardiomyopathy or stroke in the last 6 months.
  5. Any anomaly in clinical laboratory tests which may prevent safe participation in the study.
  6. Tumor diagnosed and / or treated (except basal cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) within the past 5 years.
  7. Hemoglobinopathy or chronic anemia known.
  8. Donation of one unit (500 ml) or more of blood, significant loss of blood equivalent to at least one unit of blood within the last 2 weeks or blood transfusion in the last 8 weeks.
  9. Any concomitant medical condition / disorder which, in the investigator's opinion, is likely to:

    • Will interfere with the patient's ability to complete the entire study period or participate in all study activities;
    • Require, during the study, the administration of a treatment that may affect the interpretation of the efficacy and safety data.
  10. Treatment with any oral antidiabetic medicinal product and / or herbal preparations / non-prescription medicines that may affect glycemic control within 12 weeks prior to screening.
  11. Chronic treatment with oral or parenteral corticosteroids (> 7 consecutive days of treatment) within 4 weeks prior to screening.
  12. Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion) within the last 12 weeks prior to screening.
  13. History of unstable hypertension (> 170/105 mmHg) in the last 12 weeks prior to screening.
  14. Treatment with a lipid-lowering drug that has not been kept in a stable dose within the last 8 weeks prior to screening.
  15. Treatment with thyroid hormone that has not been kept in a stable dose in the last 12 weeks prior to screening.
  16. Investigational drug use within 30 days or 5 half-lives (whichever is longer) prior to screening unless guidelines from local health authorities require a longer period.
  17. Any of the following laboratory abnormalities in screening:

    • Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) 3 times the upper limit of normality;
    • Glomerular filtration estimated by the equation kidney disease ≤ 60 ml per min by 1.73 m².
    • Fasting triglycerides > 5.6 mmol / L;
    • Thyroid stimulating hormone (TSH) outside normal range.
  18. History of substance abuse (including alcohol) within the last year.
  19. Women with potential to become pregnant and / or who are using local or systemic hormonal contraceptive method; Women in the follicular phase of the menstrual cycle and also pregnant and lactating women.
  20. Potentially unreliable patients and those considered by the Investigator as unsuitable for the study.

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): NCT03294915


Contacts
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Contact: Fernando Gerchman, MD +55 51 99993-3491 fgerchman@gmail.com
Contact: Ana Duarte, RND +55 51 98429-5548 nutrianacduarte@gmail.com

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Fernando Gerchman, MD Federal University of Rio Grande do Sul
Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03294915    
Other Study ID Numbers: 15-0155
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
prediabetes
resistant starch
insulin sensitivity
Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Glucose Intolerance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia