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Status unknownNCT03294915Updated Jul 17, 2018

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

An interventional study of Resistant Starch and Placebo in Prediabetes, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prediabetes

Keywords

  • prediabetes
  • resistant starch
  • insulin sensitivity
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Resistant Starch

    Green banana flour

    Dietary Supplement: Resistant Starch

  • Placebo comparator
    Placebo

    Maltodextrin, cellulose and guar gum

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementResistant Starch

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

  • Dietary supplementPlacebo

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

05

What researchers measure

Primary outcomes

  1. Insulin sensitivity

    Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp

    Time frame: 4 weeks

Secondary outcomes

  1. Hormonal changes

    Alteration of hormones that affect glucose metabolism, such as peptide C

    Time frame: 4 weeks

  2. Change in lipid profile

    Alteration of total cholesterol, HDL-cholesterol and triglycerides

    Time frame: 4 weeks

  3. Change total body fat

    Change total body fat will be compared before and after the intervention by means of bioimpedance

    Time frame: 4 weeks

  4. Beta cell function

    Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp

    Time frame: 4 weeks

  5. Glycemic control

    Measured by hemoglobin glycated

    Time frame: 4 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 8405710 ↗
  • 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. doi: 10.1111/dme.12623. PubMed 20536509 ↗
  • 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. PubMed 19094263 ↗
  • Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8. PubMed 15287677 ↗
  • 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. Erratum In: Diabetes Care. 2008 Sep;31(9): 1922-3. PubMed 17259476 ↗
  • 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. PubMed 9583841 ↗
  • 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. PubMed 17167471 ↗
  • 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. PubMed 19326096 ↗
  • 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. PubMed 22683134 ↗
  • 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. PubMed 22683128 ↗
  • 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. PubMed 1330528 ↗
  • 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. Erratum In: J Am Diet Assoc. 2008 May;108(5):890. PubMed 18155991 ↗
  • 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. PubMed 22745235 ↗
  • 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. PubMed 382871 ↗
  • 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. PubMed 23275361 ↗
  • 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. PubMed 20130660 ↗
  • 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. PubMed 10837282 ↗
  • 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. PubMed 21732181 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03294915
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Oct 2018 (estimated)
Primary completion
Aug 2019 (estimated)
Completion
May 2020 (estimated)
Last update
Jul 17, 2018

Study contacts

Fernando Gerchman, MD
Contact
fgerchman@gmail.com
+55 51 99993-3491
Ana Duarte, RND
Contact
nutrianacduarte@gmail.com
+55 51 98429-5548
Fernando Gerchman, MD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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