The objective of this study is to investigate the effect of broccoli seedlings on postprandial inflammatory parameters and insulin sensitivity after an oral glucose load (dual isotope technique) and monitoring the bioavailability and kinetics of SFN…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial inflammation will be tested by measuring nuclear NF-*B abundance
in peripheral blood mononuclear cells and by measuring plasma cytokine
concentrations. In addition, postprandial insulin sensitivity will be
determined by measuring plasma concentrations of glucose and insulin as well as
glucose uptake in peripheral tissues using dual isotope labelling.
Secondary outcome
Evaluate the effect of BroccoCress on insulin sensitivity after a 2nd glucose
load
Monitor the bioavailability and kinetics of SFN and related metabolites in
blood and urine
Background summary
Rationale: Meals with a high amount of available carbohydrates result in
postprandial hyperglycemia. These glucose spikes can cause an increase in
inflammatory parameters. It is hypothesized that recurring postprandial glucose
spikes can lead to decreased insulin sensitivity. Hence, it is important to
prevent postprandial inflammation. Broccoli seedlings are enriched in the
isothiocyanate sulforaphane, which is extensively studied as an anticancer
agent, but is also reported to possess antioxidant and anti-inflammatory
properties. In vitro, we showed that sulforaphane can potently inhibit TNF-α
induced NF-*B activation. Therefore, we will test the anti-inflammatory effect
of broccoli seedlings on postprandial inflammatory parameters after an oral
glucose load. Insulin sensitivity will be tested by an oral glucose load four
hours after the first glucose load. As the study concerns normal food products,
no preclinical or toxicological studies are performed with the used test meals.
Study objective
The objective of this study is to investigate the effect of broccoli seedlings
on postprandial inflammatory parameters and insulin sensitivity after an oral
glucose load (dual isotope technique) and monitoring the bioavailability and
kinetics of SFN and related metabolites in blood and urine.
Study design
Randomized, singe-blind, cross-over, exploratory intervention study
Intervention
Part A;
12 volunteers will participate in the study; each person will be studied on two
different occasions at least one week apart, consuming 8 gram butter lettuce
(Lactuca sativa var. Capitataor) or 8 gram BroccoCress. 45 minutes after either
lettuce or BroccoCress a first glucose load (75 gram glucose) will be ingested,
followed by a second load of 75 gram naturally 13C enriched glucose, 4 hours
after the first glucose load.
Part B;
4 volunteers will participate in the study; each person will be studied on one
occasion, consuming 8 gram BroccoCress (of which 4 gram will be labelled with
13C). 45 minutes after BroccoCress a first glucose load (75 gram glucose) will
be ingested, followed by a second load of 75 gram glucose, 4 hours after the
first glucose load
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The volunteers need to stay a night and a day in
the research institute on two different occasions. There will be two catheters
inserted, one for an infusion of labelled glucose and one for blood collection.
Per study day 250 mL blood will be collected at maximum, thus in total 500 mL
at maximum. In addition urine samples will be collected. The test drinks
(glucose, BroccoCress or lettuce) are food products which are not posing any
risk to the health of the volunteers. The volunteers will fill in a
questionnaire concerning habitual food intake, smoking, sportive activities and
family history of T2DM
Center for Medical Biomics, Antonius Deusinglaan 1
Groningen 9713 AV
NL
Center for Medical Biomics, Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
healthy men
Exclusion criteria
Clinical singificant abnormalities at medical research
Diabetes mellitus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL40658.056.12 |