Seaweed-derived Rhamnan Sulfate and Vascular Function

Sponsor

University of Texas at Austin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05651230

Collaborator

Konan Chemical Manufacturing (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Dietary Supplement: Rhamnan sulfate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Seaweed-derived Rhamnan Sulfate and Vascular Function

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Other Names:

Rhamnox100

Outcome Measures

Primary Outcome Measures

Vascular function [Before the 3-week intervention]
Endothelium-dependent vasodilation as assessed by flow-mediated dilation
Vascular function [After the 3-week intervention]
Endothelium-dependent vasodilation as assessed by flow-mediated dilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Aging Research Lab at UT Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin
Konan Chemical Manufacturing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05651230

Other Study ID Numbers:

STUDY00003693

First Posted:

Dec 14, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Dec 14, 2022