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

Prediabetes Clinical Trial

Official title:

Effect of Resistant Starch From Green Banana Flour on the Insulin Sensitivity of Subjects With Prediabetes: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03294915
• Other study ID #: 15-0155
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: May 2020

Study information

• Verified date: September 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Fernando Gerchman, MD
• Phone: +55 51 99993-3491
• Email: fgerchman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypersensitivity
• Insulin Resistance
• Prediabetes
• Prediabetic State

Intervention

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
Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

References & Publications (18)

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Asp NG, van Amelsvoort JM, Hautvast JG. Nutritional implications of resistant starch. Nutr Res Rev. 1996 Jan;9(1):1-31. doi: 10.1079/NRR19960004. — View Citation

DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. — View Citation

Englyst HN, Kingman SM, Cummings JH. Classification and measurement of nutritionally important starch fractions. Eur J Clin Nutr. 1992 Oct;46 Suppl 2:S33-50. — View Citation

Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8. Review. — View Citation

Johnston KL, Thomas EL, Bell JD, Frost GS, Robertson MD. Resistant starch improves insulin sensitivity in metabolic syndrome. Diabet Med. 2010 Apr;27(4):391-7. doi: 10.1111/j.1464-5491.2010.02923.x. Erratum in: Diabet Med. 2015 Feb;32(2):288. — View Citation

Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. Review. — View Citation

Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. — View Citation

Kahn SE, Zraika S, Utzschneider KM, Hull RL. The beta cell lesion in type 2 diabetes: there has to be a primary functional abnormality. Diabetologia. 2009 Jun;52(6):1003-12. doi: 10.1007/s00125-009-1321-z. Epub 2009 Mar 27. Review. — View Citation

Maki KC, Carson ML, Miller MP, Turowski M, Bell M, Wilder DM, Reeves MS. High-viscosity hydroxypropylmethylcellulose blunts postprandial glucose and insulin responses. Diabetes Care. 2007 May;30(5):1039-43. Epub 2007 Jan 26. Erratum in: Diabetes Care. 2008 Sep;31(9): 1922-3. — View Citation

Menezes EW, Tadini CC, Tribess TB, Zuleta A, Binaghi J, Pak N, Vera G, Dan MC, Bertolini AC, Cordenunsi BR, Lajolo FM. Chemical composition and nutritional value of unripe banana flour (Musa acuminata, var. Nanicão). Plant Foods Hum Nutr. 2011 Sep;66(3):231-7. doi: 10.1007/s11130-011-0238-0. — View Citation

Moulin CC, Tiskievicz F, Zelmanovitz T, de Oliveira J, Azevedo MJ, Gross JL. Use of weighed diet records in the evaluation of diets with different protein contents in patients with type 2 diabetes. Am J Clin Nutr. 1998 May;67(5):853-7. — View Citation

Murphy MM, Douglass JS, Birkett A. Resistant starch intakes in the United States. J Am Diet Assoc. 2008 Jan;108(1):67-78. Erratum in: J Am Diet Assoc. 2008 May;108(5):890. — View Citation

Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9. — View Citation

Robertson MD, Wright JW, Loizon E, Debard C, Vidal H, Shojaee-Moradie F, Russell-Jones D, Umpleby AM. Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome. J Clin Endocrinol Metab. 2012 Sep;97(9):3326-32. doi: 10.1210/jc.2012-1513. Epub 2012 Jun 28. — View Citation

Sjaarda L, Lee S, Tfayli H, Bacha F, Bertolet M, Arslanian S. Measuring ß-cell function relative to insulin sensitivity in youth: does the hyperglycemic clamp suffice? Diabetes Care. 2013 Jun;36(6):1607-12. doi: 10.2337/dc12-1508. Epub 2012 Dec 28. — View Citation

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Tarini J, Wolever TM. The fermentable fibre inulin increases postprandial serum short-chain fatty acids and reduces free-fatty acids and ghrelin in healthy subjects. Appl Physiol Nutr Metab. 2010 Feb;35(1):9-16. doi: 10.1139/H09-119. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp	4 weeks
Secondary	Hormonal changes	Alteration of hormones that affect glucose metabolism, such as peptide C	4 weeks
Secondary	Change in lipid profile	Alteration of total cholesterol, HDL-cholesterol and triglycerides	4 weeks
Secondary	Change total body fat	Change total body fat will be compared before and after the intervention by means of bioimpedance	4 weeks
Secondary	Beta cell function	Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp	4 weeks
Secondary	Glycemic control	Measured by hemoglobin glycated	4 weeks