The effect of the consumption of different wheat products on glucose kinetics and metabolic effects in healthy men
| ISRCTN | ISRCTN42106325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42106325 |
| Secondary identifying numbers | RV/TIFNC1 |
- Submission date
- 15/11/2010
- Registration date
- 10/01/2011
- Last edited
- 18/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marion Priebe
Scientific
Scientific
Center for Medical Biomics
University Medical Center Groningen (UMCG)
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands
Study information
| Study design | Single centre randomised crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Slow starch foods: an explorative pilot study - postprandial glucose kinetics and metabolic effects of different wheat products in healthy men |
| Study objectives | It was hypothesised that the consumption of wheat pasta and wheat bread with purple fibre would result in different postprandial glucose kinetics and would have a beneficial effect on several parameters involved in the pathogenesis of insulin resistance and Type 2 Diabetes Mellitus (T2DM) as compared to the consumption of a wheat bread with normal fibre. |
| Ethics approval(s) | Medical Ethics Committee of the BEBO foundation, Assen, The Netherlands approved on the 8th January 2009 (ref: CCMO NL 26384.056.08; study code 080290-CS0127) |
| Health condition(s) or problem(s) studied | Insulin resistance/type 2 diabetes mellitus |
| Intervention | Ten healthy male volunteers will participate in the study, receiving three different test meals on three separate days (at least 1 week interval). The test meals are: 1. White wheat bread with fibrer from normal wheat 2. Wheat pasta with fibre from normal wheat 3. White wheat bread with fibre from purple wheat Purple wheat fiber added to white bread might result in a slower starch digestion. Purple wheat contains a high amount of anthocyanins, which are found in vitro to have the ability to inhibit α-amylase and α-glucosidase. The test meals are enriched with the stable isotope 13C and volunteers are infused with a tracer amount of the stable isotope 2H for 8h. This method called the dual isotope technique is used in order to calculate glucose kinetics. Blood samples are drawn during the study period via a venous catheter and several breath and urine samples will be collected. |
| Intervention type | Other |
| Primary outcome measure | Glucose kinetics of the test meals, such as the rate of appearance of exogenous glucose in plasma. 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. Plasma samples were drawn at the following timepoints (in minutes, at t = 0 the test meal was consumed): -60, -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300, 330, 360. Plasma concentrations of total blood glucose and insulin are also considered as primary outcome measures. |
| Secondary outcome measures | 1. Plasma concentrations of incretins and markers of inflammation 2. Sensation of appetite and satiety (VAS registration) as well as feeling and extent of discomfort after consumption of the test meal 3. Demographic and other parameters include 3.1. Body weight 3.2. Body mass index (BMI) 3.3. Family history of T2DM 3.4. Habitual diet 3.5. Smoking habits 3.6. Sportive activities |
| Overall study start date | 01/12/2008 |
| Completion date | 05/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 10 healthy male volunteers |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Healthy male volunteer aged greater than or equal to 18 years 2. Used to eat breakfast (solid food) 3. Not involved in intensive sportive activities more than once a week (e.g. playing football, tennis, running, race-cycling, swimming) 4. Stable weight and no intention to loose weight until completion of the study |
| Key exclusion criteria | 1. Diabetes mellitus 2. Gastrointestinal disorders (including constipation) 3. Body mass index (BMI) less than 18 or greater than 25 kg/m2 4. Not being able to fast overnight (12 hours) 5. Intake of medication 6. Undergone digestive tract surgery (except appendectomy) 7. Inflammatory disease (possibly interfering with measurement of parameters in this study) 8. Donation of blood (greater than 500 ml) within the last 3 months prior to admission to the clinic 9. Participation to another clinical study within 90 days before enrolment |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 05/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Center for Medical Biomics
Groningen
9713 AV
Netherlands
9713 AV
Netherlands
Sponsor information
Top Institute Food and Nutrition (TIFN) (Netherlands)
Industry
Industry
c/o M. G. Priebe
Center for Medical Biomics
University Medical Center Groningen (UMCG)
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands
| Website | http://www.tifn.nl/ |
|---|---|
"ROR" |
https://ror.org/0183vre95 |
Funders
Funder type
Research organisation
Top Institute Food and Nutrition (TIFN) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | 18/12/2020 | Yes | No |
| Results article | results | 01/02/2017 | 18/12/2020 | Yes | No |
| Results article | sub study results | 01/02/2012 | 18/12/2020 | Yes | No |
Editorial Notes
18/12/2020: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
