RecruitingPhase 1ACTRN12614000495628

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?


Sponsor

University of Tasmania.

Enrollment

80 participants

Start Date

May 21, 2014

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Researchers are studying whether fucoidan — a natural extract from seaweed — can help control blood sugar and improve heart and metabolic health when taken daily for three months. About half of the participants will take the real fucoidan capsule, while the other half will take a placebo capsule that looks the same but has no active ingredient. This helps the researchers see whether any changes are truly caused by the supplement. You may be eligible if: - You are between 18 and 65 years old - You have a body mass index (BMI) of 30 or higher (classified as obese) You may NOT be eligible if: - You have diabetes or a parent or sibling with diabetes - You currently smoke, or have smoked in the past 30 days - Your blood sugar level at screening is higher than 7.8 mmol/L - You regularly take more than 5 medications - You take blood-thinning (anticoagulant) medication - You have a medical condition that increases your risk of bleeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 prod

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.


Locations(1)

TAS, Australia

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ACTRN12614000495628


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