Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RV/TIFNC1
Study information
Scientific title
Slow starch foods: an explorative pilot study - postprandial glucose kinetics and metabolic effects of different wheat products in healthy men
Acronym
Study hypothesis
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
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)
Study design
Single centre randomised crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/12/2008
Overall trial end date
05/02/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
10 healthy male volunteers
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
05/02/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Center for Medical Biomics
Groningen
9713 AV
Netherlands
Sponsor information
Organisation
Top Institute Food and Nutrition (TIFN) (Netherlands)
Sponsor details
c/o M. G. Priebe
Center for Medical Biomics
University Medical Center Groningen (UMCG)
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Top Institute Food and Nutrition (TIFN) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary