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

Phase 1

Recruiting

• Conditions: Obesity; Diabetes; Hyperlipidaemia; Hypercholesterolaemia; Insulin Resistance/sensitivity; Glucose tolerance; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Metabolic disorders; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12614000495628
• Lead Sponsor: niversity of Tasmania.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Body mass index >= 30 mg/m^2

Exclusion Criteria

- Diabetes or family history of diabetes (parents or siblings)
- Current smokers (participants that have smoked previously may be included, though not if they have had any cigarettes in the past 30 days or if they smoke during the study period of 3 months).
- Random blood glucose level above 7.8mM (during screening appointment).
- Fasting blood glucose level above 7mM at either study appointment.
- Taking more than 5 regular medicines.
- Taking any anticoagulant medication.
- Having any contraindication to anticoagulant medication (e.g. increased risk of bleeding due to a medical condition).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity - calculated through the HOMA (primary measure) and quantitative insulin sensitivity check index (QUICKI) scores. [After three months of dosing. ]

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose and HBA1c (a measure of glucose control, generally over the preceding 3 months). Both tests assessed through fasting venous blood sample. [After three months of dosing.];Glucose tolerance. Assessed through repeated blood glucose measurements (with a handheld glucometer) following participants drinking a sucrose (sugar) drink. [After three months of dosing.];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). [After three months dosing.];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). <br><br>[After three months of dosing. ];Weight, waist circumference and body mass index (BMI)[After three months of dosing. ]