To determine if dietary supplementation with seaweed improves glucose regulation in T2DM patients.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference between the mean blood glucose levels
measured during the first week of usual diet and during the last 5 weeks of
daily seaweed consumption. Effects of seaweed will be compared with the effect
of placebo. Blood glucose will be monitored continuously by a device
(Medtronic, Eindhoven) blinded for the participants.
Secondary outcome
Examine if Sargassum or Fucus supplementation results in bodyweight reduction
and in improvement of risk factors for cardiovascular disease (CVD). Secondary
outcomes are differences between week 1 and week 6 in terms of:
* Body weight, Glucose, HbA1c, total daily insulin use,
* Body weight, body mass index, waist-to-hip ratio, blood pressure, plasma
lipids and peripheral blood phagocyte inflammatory activation status and
ability to generate pro-angiogenic accessory cells from blood monocytes.
Background summary
Type 2 diabetes mellitus (T2DM) is a serious highly prevalent (> 1 million in
the Netherlands) chronic disease and its complications, cardiovascular disease,
retinopathy, nephropathy, neuropathy, and foot amputation lead to premature
death. Therefore there is an urge for prevention. Because diet plays an
important role in the development of T2DM, dietary interventions may provide
solutions. Seaweeds, because of its extreme growth conditions, contain unique
bioactive components that improve glucose tolerance and also circulating lipid
levels.
Study objective
To determine if dietary supplementation with seaweed improves glucose
regulation in T2DM patients.
Study design
This is a randomized placebo-controlled study to be conducted in three parallel
study arms for 6 weeks.
Researchers and participants will be blinded for the researchproduct the
participants receive.
Intervention
Patients will receive either 5 gram of Sargassum fusiforme (Sargassum), Fucus
vesiculosus (Fucus) or placebo (Nori) during 5 weeks (week 2-6). Clinical
information (anamnesis and physiological examination) and blood sampling will
be performed at the start of the study, 1 week and after 6 weeks of the study.
One week before start of the treatment and during treatment blood glucose will
be monitored continuously by a device that will be replaced weekly and that is
blinded for the participants. In week 1, 3 and 6 food intake will be recorded
in a diary.
Study burden and risks
The risk is estimated as low.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
Patients with T2DM and BMI>25
- All adults; age * 18 years
- Diabetes based on criteria of ADA
- Informed consent
Exclusion criteria
-Type 1 or monogenetic forms of diabetes.
- Thyroid disease
- Pregnancy
- Usage of corticosteroids
- Usage of blood coagulants
- History of heartfailure or recent myocardial infarction within 3 months
- Transplantation
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 | NL66189.078.18 |