Influence of Plantago Major on Mineral Metabolism and Selected Biochemical Parameters in Obese Women (Plantago)

April 4, 2022 updated by: Joanna Suliburska, Poznan University of Life Sciences

The Study on the Influence of Plantago Species (Plantago Major) on Adipose Tissue Content, Mineral Metabolism and Other Selected Biochemical Parameters of Blood in Obese Women

Effect of oral supplementation with Plantago major on cardiometabolic risk factors and mineral content and lifestyle in obese women: double-blind, randomized clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the study is to determine whether oral Plantago major supplementation affects cardiometabolic risk factors, mineral content, and lifestyle in obese women.

In previous research it was found that the Plantago maxima extract counteracts the development of adipose tissue in rats on a high-fat diet. In addition, antioxidative, anti-inflammatory and antidiabetic action of Plantago has been demonstrated. Moreover, it has been shown that Plantago influences lipolysis in obese mice and ameliorates metabolic processess in obese rats.

The project is due to evaluate the effect of oral supplementation with selected Plantago species - Plantago major in obese patients on:

  • the content of minerals in blood, hair and urine
  • total cholesterol, HDL and LDL cholesterol and triglycerides blood concentration,
  • blood glucose and insulin concentration,
  • blood pressure,
  • anthropometric parameters: body mass, body height, waist and hip circumferences
  • body content measured by bioimpedance: % of fat tissue and % of muscle tissue

  • quality of life

    70 subjects will be randomized into two groups and receive oral Plantago major extract (the first group) or oral placebo (the second group) once daily for 12 weeks. At baseline and at completion (after 12 weeks) fasting blood, urine and hair samples will be collected and abovementioned parameters will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznań, Poland, 60-624
        • Poznan University of Life Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • body mass index (BMI) equal to or greater than 30 kg/m2

    • age 18 to 60 years
    • stable body weight (< 3 kg self-reported change during the previous three months)
    • written informed consent to participate in the study,
    • abdominal obesity - waist circumference> 80 cm;
    • body fat content measured by bio-impedance ≥ 33%;
    • female

Exclusion Criteria:

  • secondary obesity or secondary hypertension
  • diabetes type I
  • gastrointestinal disease;
  • dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up;
  • a history of use of any dietary supplements within the one month prior to the study
  • clinically significant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
  • simultaneous participation in a study that affects body mass or use of diet / medication / nutritional behaviors affecting body mass;
  • a history of infection in the month prior to the study
  • nicotine, drug or alcohol abuse
  • or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Individuals receive a placebo daily, for 12 weeks.
Dietary supplement: Placebo
Individuals receive placebo daily, for 12 weeks
EXPERIMENTAL: Plantago major
Individuals receive Plantago major daily, for 12 weeks.
Dietary supplement: Plantago major
Individuals receive Plantago major daily, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mineral content
Time Frame: At the baseline and following 12 weeks of treatment
content of minerals in serum, urine and hair
At the baseline and following 12 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: At the baseline and following 12 weeks of treatment
blood pressure
At the baseline and following 12 weeks of treatment
body mass
Time Frame: At the baseline and following 12 weeks of treatment
body mass
At the baseline and following 12 weeks of treatment
body height
Time Frame: At the baseline and following 12 weeks of treatment
body height
At the baseline and following 12 weeks of treatment
hip circumference
Time Frame: At the baseline and following 12 weeks of treatment
hip circumference
At the baseline and following 12 weeks of treatment
waist circumference
Time Frame: At the baseline and following 12 weeks of treatment
waist circumference
At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of fat tissue
Time Frame: At the baseline and following 12 weeks of treatment
Content of fat tissue measured by bioimpedance
At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of muscle tissue
Time Frame: At the baseline and following 12 weeks of treatment
Content of muscle tissue measured by bioimpedance
At the baseline and following 12 weeks of treatment
serum total cholesterol
Time Frame: At the baseline and following 12 weeks of treatment
Serum concentration of total cholesterol
At the baseline and following 12 weeks of treatment
serum LDL cholesterol
Time Frame: At the baseline and following 12 weeks of treatment
Serum concentration of LDL cholesterol
At the baseline and following 12 weeks of treatment
serum HDL cholesterol
Time Frame: At the baseline and following 12 weeks of treatment
Serum concentration of HDL cholesterol
At the baseline and following 12 weeks of treatment
serum triglycerides
Time Frame: At the baseline and following 12 weeks of treatment
Serum concentration of triglycerides
At the baseline and following 12 weeks of treatment
insulin
Time Frame: At the baseline and following 12 weeks of treatment
insulin serum concentration
At the baseline and following 12 weeks of treatment
glucose
Time Frame: At the baseline and following 12 weeks of treatment
glucose serum concentration
At the baseline and following 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanna Suliburska, Assoc. Prof., Poznan University of Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1104/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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