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

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ClinicalTrials.gov Identifier: NCT03439540
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Poznan University of Medical Sciences
Information provided by (Responsible Party):
Joanna Suliburska, Poznan University of Life Sciences

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Plantago major Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. mineral content [ Time Frame: At the baseline and following 12 weeks of treatment ]
    content of minerals in serum, urine and hair


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: At the baseline and following 12 weeks of treatment ]
    blood pressure

  2. body mass [ Time Frame: At the baseline and following 12 weeks of treatment ]
    body mass

  3. body height [ Time Frame: At the baseline and following 12 weeks of treatment ]
    body height

  4. hip circumference [ Time Frame: At the baseline and following 12 weeks of treatment ]
    hip circumference

  5. waist circumference [ Time Frame: At the baseline and following 12 weeks of treatment ]
    waist circumference

  6. 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

  7. 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

  8. serum total cholesterol [ Time Frame: At the baseline and following 12 weeks of treatment ]
    Serum concentration of total cholesterol

  9. serum LDL cholesterol [ Time Frame: At the baseline and following 12 weeks of treatment ]
    Serum concentration of LDL cholesterol

  10. serum HDL cholesterol [ Time Frame: At the baseline and following 12 weeks of treatment ]
    Serum concentration of HDL cholesterol

  11. serum triglycerides [ Time Frame: At the baseline and following 12 weeks of treatment ]
    Serum concentration of triglycerides

  12. insulin [ Time Frame: At the baseline and following 12 weeks of treatment ]
    insulin serum concentration

  13. glucose [ Time Frame: At the baseline and following 12 weeks of treatment ]
    glucose serum concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439540


Contacts
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Contact: Joanna Suliburska, Assoc. Prof. +48 618487334 jsulibur@up.poznan.pl

Locations
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Poland
Poznan University of Life Sciences Recruiting
Poznań, Poland, 60-624
Contact: Joanna Suliburska, Assoc. Prof.    +48 618487334    jsulibur@up.poznan.pl   
Sponsors and Collaborators
Poznan University of Life Sciences
Poznan University of Medical Sciences
Investigators
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Principal Investigator: Joanna Suliburska, Assoc. Prof. Poznan University of Life Sciences
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Responsible Party: Joanna Suliburska, assiastant professor, Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03439540    
Other Study ID Numbers: 1104/16
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joanna Suliburska, Poznan University of Life Sciences:
Plantago major
obesity
mineral content
adipose tissue
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms