None listed
Conditions
Brief summary
Study hypothesis: That the kinetics of glucose absorption, as determined by the timing and size of the peak in blood glucose following consumption of specific carbohydrate sources with different structures, does not differ between the pig (determined in our previous studies) and the human (proposed study). Over the last few years, we have carried out a number of studies using the pig as a model for the human for carbohydrate digestion and absorption. Part of the work that has been conducted in prior pig studies has involved examining the kinetics of glucose absorption from carbohydrates made from the same ingredient, but with different physical structures (eg. Wheat: semolina porridge, couscous and pasta). To ensure the applicability of the work carried out in the pig for human nutrition, we need to compare the kinetics of glucose absorption of some of the same foods we tested in the pig, in the human. Specifically, we will be looking at the timing and size of the peak in blood glucose following consumption of the carbohydrate source (semolina porridge or pasta) versus a control (white bread).
Interventions
:There are 3 treatments each of which provide 50 g of available carbohydrates (analysed): control (white bread; 90 g of bread), semolina porridge (76.2 g dry semolina cooked with 349 g water) and pasta (81.2 g cooked in excess water). The test meals will be prepared in our Product Development Laboratory following all of the SOPs for working in this site.
Due to intra-individual variation, the recommendation is to test each product 3 times in the same participant (on different days). The average
:There are 3 treatments each of which provide 50 g of available carbohydrates (analysed): control (white bread; 90 g of bread), semolina porridge (76.2 g dry semolina cooked with 349 g water) and pasta (81.2 g cooked in excess water). The test meals will be prepared in our Product Development Laboratory following all of the SOPs for working in this site. Due to intra-individual variation, the recommendation is to test each product 3 times in the same participant (on different days). The average of the 3 tests is then used. Thus each participant will have 9 study days. The order of the treatments is randomized for each participant. As described below, the study duration will be 36 days for each participant. Continuous glucose monitors (CGM) remain active for 10.5 days. The first CGM for each participant will be applied by our staff to the back of the upper arm on the morning of day 1 (Tuesday). The CGM are more accurate following the first 12-24 hours after application (noted in the literature). Thus the first study day will begin 24 hours after the CGM has been applied. We will have 5 test days for each participant with one CGM (Wed (day 2), Fri (day 4), Mon (day 7), Wed (day 9), Fri (day 11)) before removing the CGM at the end of study day 11. Participants will then complete 18 rest days. A new CGM will be applied on day 28 for 4 more study days (Wed (day 29), Fri (day 31), Mon (day 34), Wed (day 36)). For each study day, the participants will eat as normal until 8:00pm the night before. They will be asked not to eat or drink anything other than water overnight and until they come into our facilities (Riddet Institute, Massey University). We will provide them with the test meal, which they will eat within 10-15 minutes. For the next 4 ½ hours they will remain in a room, other than to use the bathroom (to minimise physical movement), but can be reading, using laptops etc. The glucose readings will be collected with a receiver and the datapoints downloaded at the end of the 4 1/2 hour period. To confirm the calibration of the CGM, on the first study day after applying the CGM, a blood sample will be collected by fingerprick (using a one-use sterile lancet) and the blood glucose measured to calibrate the CGM. The researchers that will be conducting the study have 28 or 12 years' experience in pre-clinical and clinical studies.
Sponsors
Suzanne Hodgkinson, Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
• Male or female • BMI between 18 and 27 kg/m2 • Good general health
Exclusion criteria
• Having Body Mass Index (BMI) less than 18 or more than 27 kg/m2 • Level of HbA1c in blood >40 nmol/ml (determined as part of the screening process) indicating participant may have or be at risk of having diabetes • Having a history of gastrointestinal disorders or established health problems such as inflammatory bowel disease, endocrine disorders, diabetes • Currently taking antibiotics or have taken antibiotics within one month of the study • Taking other medications that may affect digestion and absorption • Pregnant or breastfeeding, or planning to become pregnant during the study • Smoke cigarettes • Consume more than 2 units (standard serves) of alcohol per day • Gluten intolerant • On a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study • Having tattoos, scarring or irritations covering the back of both arms (may interfere with functioning of CGM)
Outcome results
None listed