NCT01960946

Brief Summary

This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been deemed as 'generally regarded as safe' by the FDA. This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood pressure. The study will help understand how MCP may affect the risk for heart disease in patients with high blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

4.9 years

First QC Date

October 9, 2013

Last Update Submit

February 17, 2021

Conditions

Hypertension

Keywords

HypertensionGalectin 3FibrosisVascular StiffnessEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Change in markers of collagen metabolism

    Primary aim will be change in markers of collagen metabolism (PICP, PIIICP, ICTP, TIMP-1) in MCP versus placebo groups over 6 months of treatment.

    Baseline and 6 months

Secondary Outcomes (3)

  • Change in galectin-3 level

    Baseline and 6 months

  • Changes in cardiac structure and function

    Baseline and 6 months

  • Changes in arterial stiffness

    Baseline and 6 months

Study Arms (2)

Modified Citrus Pectin (MCP)

ACTIVE COMPARATOR

Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day

Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo

Placebo

PLACEBO COMPARATOR

Matched placebo 5 grams by mouth three times a day

Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo

Interventions

Modified Citrus Pectin (MCP) vs placeboDIETARY_SUPPLEMENT

5 grams by mouth three times a day

Also known as: MCP, PectaSol-C
Modified Citrus Pectin (MCP)Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-70 years
  • Physician diagnosed hypertension on stable therapy for 3 months
  • Elevated galectin-3 level (above sex-specific median based on Framingham Heart Study measures)
  • Able to understand the protocol and provide informed consent in English

You may not qualify if:

  • Uncontrolled hypertension, defined as systolic blood pressure \> 170mmHg, diastolic blood pressure \> 100mmHg
  • Evidence of secondary hypertension
  • History of heart failure, coronary artery disease, stroke, atrial fibrillation
  • Left ventricular ejection fraction \< 45% on echocardiography
  • Use of aldosterone antagonists
  • History of liver cirrhosis
  • History of pulmonary fibrosis
  • Kidney dysfunction, defined as estimated glomerular filtration rate \< 45 ml/min/1.73m2
  • Anemia, defined as hematocrit \< 37% in men and \< 34% in women
  • Use of chelating agents
  • History of Active cancer or malignancy
  • Known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
  • Hyperkalemia on screening labs, defined as potassium \>5.2
  • Anticipated inability to complete or comply with study protocol
  • History of angioedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Lau ES, Liu E, Paniagua SM, Sarma AA, Zampierollo G, Lopez B, Diez J, Wang TJ, Ho JE. Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension. JACC Basic Transl Sci. 2021 Jan 6;6(1):12-21. doi: 10.1016/j.jacbts.2020.10.006. eCollection 2021 Jan.

    PMID: 33532663RESULT

MeSH Terms

Conditions

HypertensionFibrosis

Interventions

citrus pectin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer E Ho, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Medicine

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)