Seaweed-derived Rhamnan Sulfate and Vascular Function

Study Overview
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Brief Summary
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The primary aim of the proposed investigation is to examine the hypothesis that a relatively short period of rhamnan sulfate supplementation would improve key markers of vascular dysfunction in middle-aged and older adults with at least one risk factors for cardiovascular disease.

Official Title
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Seaweed-derived Rhamnan Sulfate and Vascular Function

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Rhamnan sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one risk factor for cardiovascular disease (e.g., dyslipidemia, hypertension, obesity, impaired fasting glucose) a BMI of <40 kg/m2 Exclusion Criteria: gastrointestinal disorders and/or renal disease pregnancy or lactation strenuous physical activity (>3 times/week) alcohol abuse

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhamnan sulfate<br>The subjects will take rhamnan sulfate (Rhamnox100, Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) orally three time daily at each meal time. | Dietary Supplement: Rhamnan sulfate<br>* A randomized, placebo-controlled, double-blind crossover dietary supplement intervention consisting of 3 weeks each of rhamnan sulfate (Rhamnox100, Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) or placebo with 2 weeks of washout between the interventions will be conducted. Dietary supplements (rhamnan sulfate) will be taken orally three time daily at each meal time. Rhamnan sulfate is a polysaccharide (carbohydrate) extracted from seaweeds and can be considered nutrition supplement. As each pill contains 90 mg of rhamnan sulfate or placebo, subjects will be taking 2 pills before or during each meal.<br>* Other names: Rhamnox100;|
| Placebo Comparator: Placebo<br>The subjects will take placebo (Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) orally three time daily at each meal time. | Dietary Supplement: Rhamnan sulfate<br>* A randomized, placebo-controlled, double-blind crossover dietary supplement intervention consisting of 3 weeks each of rhamnan sulfate (Rhamnox100, Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) or placebo with 2 weeks of washout between the interventions will be conducted. Dietary supplements (rhamnan sulfate) will be taken orally three time daily at each meal time. Rhamnan sulfate is a polysaccharide (carbohydrate) extracted from seaweeds and can be considered nutrition supplement. As each pill contains 90 mg of rhamnan sulfate or placebo, subjects will be taking 2 pills before or during each meal.<br>* Other names: Rhamnox100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Endothelium-dependent vasodilation as assessed by flow-mediated dilation | Before the 3-week intervention | 
| Vascular function | Endothelium-dependent vasodilation as assessed by flow-mediated dilation | After the 3-week intervention |