Effect of Fucoidan on glucose control and markers of cardiometabolic health after chronic dosing
In an obese, non-diabetic population, does twice daily dosing of a commercially available fucoidan extract over three months, when compared to placebo, lead to changes in glucose control and other markers of cardiometabolic health?
University of Tasmania.
80 participants
May 21, 2014
Interventional
Conditions
Summary
This study is looking to assess if a commercially available seawead extract (fucoidan) has an effect on blood sugar and insulin levels, as well as other markers of cardio (heart) and metabolic health, when taken over three months. To allow us to assess its impact, one half (approx 40) of the enrolled participants will take a placebo capsule which does not contain fucoidan or any other active ingredient.
Eligibility
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Interventions
Arm One: Participants will be asked to take ONE capsule twice daily, for 3 months, of a commercially available seaweed extract (Maritech Synergy) equivalent to 500mg of fucoidan per capsule. This product is classified as a dietary supplement. Participants will attend one screening appointment to assess eligibility. If eligible, participants will be asked to attend another appointment (called study appointment one) to provide written and informed consent, be randomly allocated to arm 1 or arm 2 of the study and take baseline measurements: blood pressure, height, weight, waist circumference, fasting blood glucose, HBA1c, insulin, lipid profile, liver, kidney and blood system function tests. At this point participants will also be asked to provide information on current medical conditions and medications. Participants will be provided with a 75g in 125mL sucrose (sugar) drink and measurements taken at set time points over two hours following the drink. Adherence will be encouraged through fortnightly phone calls (as far as practicable). A follow up appointment will be made at the end of the 3 month course of capsules, with the procedure identical to study appointment one, barring written and informed consent which will have already been obtained. Participants will be asked to inform researchers of any changes to medical conditions, medications, exercise habits, diet and alcohol intake over the previous three months, during this appointment. Adherence to treatment will be checked through capsule counting and patient self-report ("How many times have you missed a dose in the past week?") at the conclusion of the trial.
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ACTRN12614000495628