|- candidate number||8660|
|- NTR Number||NTR2608|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-nov-2010|
|- Secondary IDs||NL31397.056.10 CCMO|
|- Public Title||In vivo evaluation of high-amylose potato products using the dual isotope technique in healthy men.|
|- Scientific Title||In vivo evaluation of high-amylose potato products using the dual isotope technique in healthy men.|
|- hypothesis||Consumption of potato products with a higher amylose/amylopectin ratio is expected to result in increased colonic fermentation as well as in lower postprandial glucose and insulin concentrations compared to the consumption of conventional potato products.
A lower glycemic response is favourable for patients with Type 2 Diabetes Mellitus (T2DM) and might also decrease the risk of developing obesity and T2DM.
To investigate the differences in rate and extent of digestion as well as in colonic fermentation of HAM compared to that of CON (using the dual isotope technique).
To investigate what is the difference in glycemic and insulinemic response and the plasma concentrations of incretins and inflammation markers after consumption of HAM compared to CON.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Insulin resistance|
|- Inclusion criteria||1. Healthy male volunteer aged ≥ 18;|
2. Used to eat breakfast (solid food);
3. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, race-cycling, swimming);
4. Produces hydrogen after ingestion of fermentable carbohydrates;
5. Stable weight and no intention to loose weight until completion of the study.
|- Exclusion criteria||1. Diabetes mellitus;|
2. Gastrointestinal disorders (including constipation);
3. BMI < 18 or > 25 kg/m2;
4. Not being able to fast overnight (12 hours);
5. Intake of medication (from 2 weeks before screening until the end of the study, except for sporadic use of paracetamol and/or treating an AE);
6. Undergone digestive tract surgery (except appendectomy);
7. Intake of antibiotics in the three months before the study;
8. Intake of pre- or probiotics more than once per week;
9. Donation of blood (> 500 mL) within the last 3 months prior to admission to the clinic;
10. Inflammatory disease (possibly interfering with measurement of parameters in this study);
11. Participation to another clinical study within 90 days before enrolment;
12. Positive drug screen or alcohol breath test at day before study.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-sep-2010|
|- planned closingdate||1-sep-2011|
|- Target number of participants||12|
|- Interventions||In this explorative intervention study two different test meals will be consumed, with at least one week between each test meal. In the test meals, which will be made from potato puree and starch, the ratio of amylose and amylopectin will differ. The high amylose test meal will have an amylose/amylopectin ratio of 50/50, whereas the conventional test meal will have an amylose/amylopectin ratio of 20/80 (which is the ratio in potatoes).
The volunteer will drink 250 mL of water with the test meal. The test meals are enriched with the stable isotope 13C and volunteers are infused with a tracer amount of the stable isotope 2H for 6 h. This method called the ¡®dual isotope technique¡¯ is used in order to calculate glucose kinetics.
|- Primary outcome||The main parameters of this study are the rate of appearance of exogenous glucose in plasma (glucose kinetics) as well as the quantity of fermentation products.
Glucose kinetics is calculated using total plasma glucose concentration, the 13C/12C-ratio of glucose in plasma samples, and the 2H/1H-glucose ratio in plasma samples.
Parameters of fermentation measured are hydrogen in breath, 13CO2 in breath, short chain fatty acids in plasma and urine. |
|- Secondary outcome||The secondary study parameters are plasma concentrations of total blood glucose, insulin, incretins and markers of inflammation. Sensation of appetite and satiety (VAS registration) as well as feeling and extent of discomfort after consumption of the test meal are also considered as secondary parameters. Other study parameters include body weight, BMI, family history of T2DM, habitual diet, smoking habits and sportive activities.|
|- Timepoints||Blood samples are drawn during the whole 15h study period (2x) via a venous catheter and several breath and urine samples will be collected.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.G. Priebe|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.G. Priebe|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Carbohydrate Competence Centre (CCC)|
(Source(s) of Monetary or Material Support)
|Carbohydrate Competence Centre (CCC)|
|- Brief summary||Consumption of potato products with a higher amylose/amylopectin ratio is expected to result in increased colonic fermentation as well as in lower postprandial glucose and insulin concentrations compared to the consumption of conventional potato products. This will be investigated in young, healthy men using the dual isotope technique.|
|- Main changes (audit trail)|
|- RECORD||12-nov-2010 - 25-jul-2011|