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

NCT03294915 | Unknown

• 1 other identifier: 15-0155
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prediabetes

Keywords

prediabetes; resistant starch; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp

  4 weeks

Secondary Outcomes (5)

• Hormonal changes

  4 weeks

• Change in lipid profile

  4 weeks

• Change total body fat

  4 weeks

• Beta cell function

  4 weeks

• Glycemic control

  4 weeks

Study Arms (2)

Resistant Starch

ACTIVE COMPARATOR

Green banana flour

Dietary Supplement: Resistant Starch

Placebo

PLACEBO COMPARATOR

Maltodextrin, cellulose and guar gum

Dietary Supplement: Placebo

Interventions

Resistant Starch DIETARY_SUPPLEMENT

Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants

Resistant Starch

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Body mass index (BMI) ≥ 25 kg / m² (≥23 kg / m² for those of Asian origin) and ≤ 35 kg / m² for screening.
• Stable weight (maximum variation of approximately 5%) for at least 4 weeks prior to screening.
• Apt and willing to provide the written informed consent term and to comply with the requirements of the study protocol.

You may not qualify if:

• Clinically symptomatic gastrointestinal disease including, but not limited to, inflammatory bowel disease.
• History of gastric bypass, antrectomy, or resection of the small intestine.
• History of chronic pancreatitis or acute idiopathic pancreatitis.
• Myocardial infarction, coronary artery bypass grafting, post-transplant cardiomyopathy or stroke in the last 6 months.
• Any anomaly in clinical laboratory tests which may prevent safe participation in the study.
• Tumor diagnosed and / or treated (except basal cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) within the past 5 years.
• Hemoglobinopathy or chronic anemia known.
• 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.
• 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.
• 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.
• Chronic treatment with oral or parenteral corticosteroids (\> 7 consecutive days of treatment) within 4 weeks prior to screening.
• Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion) within the last 12 weeks prior to screening.
• History of unstable hypertension (\> 170/105 mmHg) in the last 12 weeks prior to screening.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Related Publications (18)

• 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. doi: 10.2337/diab.42.11.1663.

  PMID: 8405710 BACKGROUND

• 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.

  PMID: 20536509 BACKGROUND

• 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. No abstract available.

  PMID: 19094263 BACKGROUND

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

  PMID: 15287677 BACKGROUND

• 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. doi: 10.2337/dc06-2344. Epub 2007 Jan 26.

  PMID: 17259476 BACKGROUND

• 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. doi: 10.1093/ajcn/67.5.853.

  PMID: 9583841 BACKGROUND

• Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482.

  PMID: 17167471 BACKGROUND

• 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.

  PMID: 19326096 BACKGROUND

• 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.

  PMID: 22683134 BACKGROUND

• Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.

  PMID: 22683128 BACKGROUND

• 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.

  PMID: 1330528 BACKGROUND

• Murphy MM, Douglass JS, Birkett A. Resistant starch intakes in the United States. J Am Diet Assoc. 2008 Jan;108(1):67-78. doi: 10.1016/j.jada.2007.10.012.

  PMID: 18155991 BACKGROUND

• 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.

  PMID: 22745235 BACKGROUND

• 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. doi: 10.1152/ajpendo.1979.237.3.E214.

  PMID: 382871 BACKGROUND

• Sjaarda L, Lee S, Tfayli H, Bacha F, Bertolet M, Arslanian S. Measuring beta-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.

  PMID: 23275361 BACKGROUND

• 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.

  PMID: 20130660 BACKGROUND

• Anderson JW, Davidson MH, Blonde L, Brown WV, Howard WJ, Ginsberg H, Allgood LD, Weingand KW. Long-term cholesterol-lowering effects of psyllium as an adjunct to diet therapy in the treatment of hypercholesterolemia. Am J Clin Nutr. 2000 Jun;71(6):1433-8. doi: 10.1093/ajcn/71.6.1433.

  PMID: 10837282 BACKGROUND

• 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. Nanicao). Plant Foods Hum Nutr. 2011 Sep;66(3):231-7. doi: 10.1007/s11130-011-0238-0.

  PMID: 21732181 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fernando Gerchman, MD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Gerchman, MD

CONTACT

+55 51 99993-3491; fgerchman@gmail.com

Ana Duarte, RND

CONTACT

+55 51 98429-5548; nutrianacduarte@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: September 27, 2017
• Study Start: October 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: May 1, 2020
• Last Updated: July 17, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share