Seaweed-derived Rhamnan Sulfate and Vascular Function

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Rhamnan sulfate

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • Cardiovascular Aging Research Lab at UT Austin
      • Principal Investigator: Hirofumi Tanaka, PhD
      • Contact: Hirofumi Tanaka, PhD; Phone Number: 512-232-4801; Email: htanaka@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhamnan sulfate; 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; 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.; Other Names: Rhamnox100
Placebo Comparator: Placebo; 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; 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.; Other Names: Rhamnox100

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Konan Chemical Manufacturing

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: STUDY00003693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable request after the research findings are published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No