Effects of seaweed on blood glucose

Rationale: 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 contain unique bioactive components that improve glucose tolerance and also circulating lipid levels.
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.
Study population: Sixty eligible patients with T2DM and a BMI > 25 will be enrolled. The study will be performed in patients with T2D and a BMI>25
The participants are allowed for inclusion in the study only after written informed consent and approval by our Medical Ethical Review Board. Exclusion criteria are type 1 or monogenetic forms of diabetes, thyroid disease, pregnancy use of blood coagulants and corticosteroids, heart failure and recent myocardial infarction The participants are allowed for inclusion in the study only after written informed consent and approval by our Medical Ethical Review Board.
Intervention (if applicable): Patients will receive either 5 gram of Sargassum fusiforme (Sargassum), Fucus vesiculosus (Fucus) or placebo (0.5 gram 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, blinded for the participants.
This study will be conducted in compliance with Good Clinical Practices (GCP) and
ICH guidelines
Main study parameters/endpoints: Main study parameters/endpoints: Difference between the mean blood glucose levels measured during the first week of usual diet and during week 2 to 6 when daily seaweed is consumed.
Secondary outcomes are differences between week 1 and week 6 in terms of body weight (kg) because seaweed consumption can contribute to weight loss; HbA1c and total daily insulin use, and fasting blood glucose levels (Mmol/L) in addition to the continuously monitored glucose levels. Levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, lipoprotein (a) (g/L), apoB100/48 (Mmol/L) and triglycerides (Mmol/L) (measured using routine laboratory analysis) will be analyzed, and pulse wave velocity and blood pressure (mmHg) and cytokines.

We hypothesize that dietary supplementation with seaweed will improve glucose regulation in T2DM patients.

baseline (week 1) - week 2-6 (continuous glucose monitoring)

Patients will receive either 5 gram of Sargassum fusiforme (Sargassum), 5 gram of Fucus vesiculosus (Fucus) or placebo (0.5 gram Nori) during 5 weeks (week 2-6).