Seaweed-derived Rhamnan Sulfate and Vascular Function

Cardiovascular Diseases Clinical Trial

Official title:

Seaweed-derived Rhamnan Sulfate and Vascular Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651230
• Other study ID #: STUDY00003693
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Rhamnan sulfate
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.

Locations

Country	Name	City	State
United States	Cardiovascular Aging Research Lab at UT Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Konan Chemical Manufacturing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function	Endothelium-dependent vasodilation as assessed by flow-mediated dilation	Before the 3-week intervention
Primary	Vascular function	Endothelium-dependent vasodilation as assessed by flow-mediated dilation	After the 3-week intervention