PrediabetesNCT03294915
Effect of Resistant Starch on Insulin Sensitivity and Beta Cell Function in Subjects With Prediabetes
A study testing Resistant Starch in people with Prediabetes, run by Hospital de Clinicas de Porto Alegre.
Trial summary
To compare the use supplementation based on green banana flour versus placebo in the insulin sensitivity on individuals who have prediabetes. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Resistant Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- Treatment with a lipid-lowering drug that has not been kept in a stable dose within the last 8 weeks prior to screening.
- Treatment with thyroid hormone that has not been kept in a stable dose in the last 12 weeks prior to screening.
- 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.
- 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.
- History of substance abuse (including alcohol) within the last year.
- 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.
- Potentially unreliable patients and those considered by the Investigator as unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Resistant Starch From Green Banana Flour on the Insulin Sensitivity of Subjects With Prediabetes: Randomized Clinical Trial
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.
- Conditions
- Prediabetes
- Being tested
- Resistant Starch, Placebo
- Keywords
- prediabetes, resistant starch, insulin sensitivity
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchDietary supplement
Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants
PlaceboDietary supplement
Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch | Active comparator | Green banana flour Receives: Dietary Supplement: Resistant Starch |
| Placebo | Placebo comparator | Maltodextrin, cellulose and guar gum Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp
Measured: 4 weeks
Secondary outcomes (5)
Hormonal changes
Alteration of hormones that affect glucose metabolism, such as peptide C
Measured: 4 weeks
Change in lipid profile
Alteration of total cholesterol, HDL-cholesterol and triglycerides
Measured: 4 weeks
Change total body fat
Change total body fat will be compared before and after the intervention by means of bioimpedance
Measured: 4 weeks
Beta cell function
Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp
Measured: 4 weeks
Glycemic control
Measured by hemoglobin glycated
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startOct 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Gerchman, MD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294915
- Sponsor's protocol ID
- 15-0155
- Status last verified
- Sep 2017
- First submitted
- 28 Jun 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 8405710Johnston 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.
PubMed 20536509Asp 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 19094263Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8.
PubMed 15287677Maki 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.
PubMed 17259476Moulin 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 9583841Kahn 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 17167471Kahn 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 19326096Perreault 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 22683134Tabak 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 22683128Englyst 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 1330528Murphy 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.
PubMed 18155991Robertson 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 22745235DeFronzo 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 382871Sjaarda 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistant Starch From Green Banana Flour on the Insulin Sensitivity of Subjects With Prediabetes: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03294915
- Acronym / sponsor ID
- 15-0155
- Conditions
- Prediabetes
- Keywords
- prediabetes, resistant starch, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the use supplementation based on green banana flour versus placebo in the insulin sensitivity on individuals who have prediabetes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch | Active comparator | Dietary Supplement: Resistant StarchGreen banana flour |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin, cellulose and guar gum |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant StarchAddition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants | Dietary supplement | Resistant Starch |
| PlaceboAddition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants | Dietary supplement | Placebo |
Primary outcome
Insulin sensitivity
Time frame: 4 weeks
Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp
5 secondary outcomes
Hormonal changes
Time frame: 4 weeks
Change in lipid profile
Time frame: 4 weeks
Change total body fat
Time frame: 4 weeks
Beta cell function
Time frame: 4 weeks
Glycemic control
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 8405710Kahn 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.
- Background: PubMed 20536509Johnston 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.
- Background: PubMed 19094263Asp 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.
- Background: PubMed 15287677Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8.
- Background: PubMed 17259476Maki 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.
- Background: PubMed 9583841Moulin 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.
- Background: PubMed 17167471Kahn 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.
- Background: PubMed 19326096Kahn 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.
- Background: PubMed 22683134Perreault 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.
- Background: PubMed 22683128Tabak 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.
- Background: PubMed 1330528Englyst HN, Kingman SM, Cummings JH. Classification and measurement of nutritionally important starch fractions. Eur J Clin Nutr. 1992 Oct;46 Suppl 2:S33-50.
- Background: PubMed 18155991Murphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Gerchman, MD principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch in people with Prediabetes, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Gerchman, MD (+55 51 99993-3491, fgerchman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294915, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.