The objective of the current study is to evaluate and compare the glucose responses after consumption of each of the 2 whole grain foods (2 types of 'ontbijtkoek') and white bread. Furthermore, related effects (of the glucose responses) on…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood glucose response after consumption of the test products (2 grain-based
baked food products and white bread).
Secondary outcome
Related effects (of the glucose responses) on subjective ratings of hunger and
satiety.
Correlation between the obtained in vivo data and in vitro digestion data
resulting from trials at TNO-Zeist.
Background summary
Whole grain foods thought to be low glycemic, and able to decrease the glycemic
load of meals. Addition of food fibers (aleuron, betaglucans) is expected to
further reduce the glycemic response and is also expected to impact on hunger
and satiety feelings.
Study objective
The objective of the current study is to evaluate and compare the glucose
responses after consumption of each of the 2 whole grain foods (2 types of
'ontbijtkoek') and white bread. Furthermore, related effects (of the glucose
responses) on subjective measures of satiety and hunger will be evaluated.
Furthermore, we aim to study the correlation between the obtained in vivo data
(current study) and in vitro digestion data resulting from trials at TNO-Zeist.
Study design
The current study will be executed conform a randomized, cross-over,
reference-controlled, study design. During the glycaemic response test days, 3
test products (including white wheat bread as control) will be tested on 3
separate test days. The order in which the test products will be presented to
participants will be randomized by a statistician. Glucose responses to each of
the test products will be measured by obtaining blood samples before (t = 0)
and after administration of the test products (t = 15, 30, 45, 60, 90, 120, 150
min).
Intervention
Participants will be provided with different test products at the start of each
test day, namely 2 different types of 'Ontbijtkoek' and white bread. They will
be provided in a random order. The glucose response to each of these test
products will be measured during each test day, as well as participants'
subjective ratings of hunger and satiety.
Study burden and risks
All participants who will be recruited for this study are healthy and not
suffering from any diseases that put them at risk during the course of this
research. Furthermore, as mentioned before, all foods tested in this study are
made for human consumption, according to standard food production procedures.
All in ingredients used in these foods are food grade and commonly used in the
Dutch food industry. So there are no risks concerning the test products.
Concerning the blood sampling there are minor usual risks as always present
during needle insertion and sampling moments.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• 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
• Protein and glucose are not allowed to be present in urine that will be collected
during screening.
• Subjects have to be healthy (self reported) and are not allowed to use medication
that can interfere with the current study.
• Normal Dutch dietary eating habits (no vegan, vegetarian or macrobiotic lifestyle)
Exclusion criteria
• 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
• Pregnant or lactating or wishing to become pregnant in the period of the study
• currently in menopause / post-menopausal
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43759.068.13 |
| Other | We hebben het onderzoeksprotocol bij het NTR geregistreerd maar tot op heden nog geen NTR nummer ontvangen - jullie krijgen dit zodra wij een nummer hebben |
| OMON | NL-OMON29362 |