Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/11/2010
Date assigned
10/01/2011
Last edited
10/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marion Priebe

ORCID ID

Contact details

Center for Medical Biomics
University Medical Center Groningen (UMCG)
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands

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

http://www.tifn.nl/

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

Publication citations

Additional files

Editorial Notes