Seaweed-derived Rhamnan Sulfate and Vascular Function
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJune 9, 2026
March 1, 2025
1.6 years
November 28, 2022
June 5, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Rhamnan sulfate
EXPERIMENTALThe subjects will take rhamnan sulfate (Rhamnox100, Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) orally three time daily at each meal time.
Placebo
PLACEBO COMPARATORThe subjects will take placebo (Konan Chemical Manufacturing Co. LTD, Mie, Japan: 540 mg/day) orally three time daily at each meal time.
Interventions
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.
Eligibility Criteria
You may qualify if:
- at least one risk factor for cardiovascular disease (e.g., dyslipidemia, hypertension, obesity, impaired fasting glucose)
- a BMI of \<40 kg/m2
You may not qualify if:
- gastrointestinal disorders and/or renal disease
- pregnancy or lactation
- strenuous physical activity (\>3 times/week)
- alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 14, 2022
Study Start
April 1, 2023
Primary Completion
November 1, 2024
Study Completion
February 1, 2025
Last Updated
June 9, 2026
Record last verified: 2025-03