NCT06559982

Brief Summary

The brown seaweed species Ascophyllum nodosum is rich in bioactive polysaccharides, proteins, peptides, lipids, pigments, and polyphenols. Similarly, Montmorency tart cherry (Prunus cerasus L.) is high in anthocyanins and polyphenols. Both substances have antioxidant, anti-inflammatory, and vasodilatory properties that target mechanisms central to hypertension and cardiometabolic diseases. Dietary interventions to improve cardiovascular health are highly sought after as they possess less risk and financial burden than pharmacological drugs. Previous randomized trial has shown that both brown seaweed and tart cherry supplementation can improving systolic blood pressure and other cardiovascular/ blood lipids. However, to date, no research has explored a seaweed - tart cherry blend using a placebo randomized intervention in patients with hypertension. The primary purpose of the proposed investigation is to test the ability of a seaweed - tart cherry supplementation blend to improve cardiometabolic parameters in participants with mild-moderate hypertension using a pilot/ feasibility study.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress87%
May 2025Jul 2026

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 15, 2024

Last Update Submit

August 18, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Systolic blood pressure

    Systolic blood pressure - measured using a digital blood pressure monitor

    Baseline

  • Systolic blood pressure

    Systolic blood pressure - measured using a digital blood pressure monitor

    20 days

Secondary Outcomes (32)

  • Diastolic blood pressure

    Baseline

  • Diastolic blood pressure

    20 days

  • Percent bodyfat and fat mass

    Baseline

  • Percent bodyfat and fat mass

    20 days

  • Waist circumference

    Baseline

  • +27 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical in taste and colour to the supplement juice, but with no peppermint content.

Other: Placebo

Brown seaweed and tart cherry blend

EXPERIMENTAL
Dietary Supplement: Brown seaweed and tart cherry blend

Interventions

Brown seaweed and tart cherry blendDIETARY_SUPPLEMENT

Blend of brown seaweed and tart cherry blend taken twice daily

Brown seaweed and tart cherry blend
PlaceboOTHER

Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 18-65 years
  • Systolic blood pressure 120 to 139 mmHg
  • Not taking prescribed medicine for blood pressure management
  • Ability to complete written questionnaires independently
  • Able to provide informed consent

You may not qualify if:

  • Diagnosed with diabetes mellitus and/ or coronary heart disease
  • Pregnant and lactating women
  • Allergy to peppermint
  • Habitual consumption of peppermint products
  • Regular consumption of antioxidant supplements
  • Body mass index larger than 40.0 kg/m2
  • Current enrolment in other clinical trials of other external therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Jonathan Sinclair, PhD, DSc

CONTACT

07875651533jksinclair@uclan.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

GB(1)