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De glycaemische index van verschillende graanproducten bij gezonde vrijwilligers.

Conditions
/AWe will study healthy subjects (healthy BMI, not suffering from metabolic diseases / diabetes / obesity / gastrointestinal disorders) and investigate the blood glucose response to three different grain based foods.
Registration Number
NL-OMON29362
Lead Sponsor
Maastricht University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other
Sex
Not specified
Target Recruitment
14
Inclusion Criteria

Measured during screening:
•Blood pressure: diastolic blood pressure between 60 and 90 mmHg and a systolic
blood pressure between 100 and 150 mmHg
•Body Mass Index (BMI; weight/length2) between 18 and 25 kg/m2
•Subjects have to be healthy (self reported – a score of 4/5 out of 5 on the screening questionnaire) and are not allowed to use medication
that can interfere with the current study (drugs that are not allowed during the study are listed in section 4.3 Exclusion criteria).
•Master the Dutch language (as VAS questionnaires are in Dutch)
•Fasted blood glucose has to be < 7.1 mmol/L.

Furthermore, the subjects must have:
•Normal Dutch dietary eating habits (no vegetarian, vegan or macrobiotic lifestyle)
•To participate voluntary (give written informed consent)
•To be willing to comply with the study procedures
•To be willing to accept use and storage of all data, publication of nameless data
•To be willing to accept the disclosure of the financial benefit to participation in the
study to the authorities concerned.

Exclusion Criteria

•Recent participation in any clinical trial (<30 days)
•Having a history of medical or surgical events that may significantly affect the
study outcome (gastro-intestinal diseases)
•Any current metabolic or endocrine disease
•Diabetes Mellitus (type I and II)
•More than 28 consumptions of alcohol a week (for men) and more than 21 consumptions of alcohol a week (for women)
•Reported intolerance for gluten
•Having regularly gastro-intestinal complaints (stomach upsets, diarrhea, constipation, wind, abdominal colic)
•Reported unexplained weight loss or gain of >2kg in the month prior to the pre-study screening
•Reported slimming or medically prescribed diet
•Reported vegan, vegetarian or macrobiotic lifestyle
•Use of antibiotics during the last three months
•Smoking
•Pregnant or lactating or wishing to become pregnant in the period of the study
•Not having a general practitioner
•Not willing to accept information-transfer concerning participation in the study, or
information regarding health of the subject, like findings at anamnesis or physical examination and eventual adverse events to and from general practitioner
•The subject will be excluded from the study if he / she does not want to be informed about deviating findings / accidental findings concerning his / her health
•The following drugs are not allowed during the study:
1.Anti-hypertensive drugs
2.Lipid lowering-drugs
3.Glucose-lowering agents.
4.Anti-inflammatory agents
5.Chronic oral or parenteral corticosteroids treatment (> 7 consecutive days of treatment).
6.Laxatives, antibiotics, anti-diarrhea drugs

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The post-prrandial glucose response and glycaemic index after consumption of all 3 above named test products (2 types of ‘Ontbijtkoek’ differing in grain flour composition and the reference product, white bread).
Secondary Outcome Measures
NameTimeMethod
Subjective measures of satiety and hunger in response to all 3 above named test products (2 types of ‘Ontbijtkoek’ differing in grain flour composition and the reference product, white bread).
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