Effect of Fucoidan on glucose control and markers of cardiometabolic health after chronic dosing

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: 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. CONDITION: Diabetes Glucose tolerance Hypercholesterolaemia Hyperlipidaemia Insulin Resistance/sensitivity Obesity PRIMARY OUTCOME: Insulin sensitivity ‐ calculated through the HOMA (primary measure) and quantitative insulin sensitivity check index (QUICKI) scores. SECONDARY OUTCOME: Fasting blood glucose and HBA1c (a measure of glucose control, generally over the preceding 3 months). Both tests assessed through fasting venous blood sample. Glucose tolerance. Assessed through repeated blood glucose measurements (with a handheld glucometer) following participants drinking a sucrose (sugar) drink. Lipid profile ‐ including total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. Assessed through a fasting venous blood sample (total cholesterol level, HDL, LDL and triglyceride asssay). Liver, kidney and blood system function. Assessed through a urea, electrolyte and creatinine (UEC) test, a liver function test and a full blood picture (from a fasting venous blood sample). ; ; Weight, waist circumference and body mass index (BMI) INCLUSION CRITERIA: Body mass index >= 30 mg/m^2
Epistemonikos ID: bf03034a7abf1d2ca8f3f5fce41c76434f3fc724
First added on: Aug 25, 2024