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

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: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Plantago major

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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mineral content	content of minerals in serum, urine and hair	At the baseline and following 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	blood pressure	At the baseline and following 12 weeks of treatment
body mass	body mass	At the baseline and following 12 weeks of treatment
body height	body height	At the baseline and following 12 weeks of treatment
hip circumference	hip circumference	At the baseline and following 12 weeks of treatment
waist circumference	waist circumference	At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of fat tissue	Content of fat tissue measured by bioimpedance	At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of muscle tissue	Content of muscle tissue measured by bioimpedance	At the baseline and following 12 weeks of treatment
serum total cholesterol	Serum concentration of total cholesterol	At the baseline and following 12 weeks of treatment
serum LDL cholesterol	Serum concentration of LDL cholesterol	At the baseline and following 12 weeks of treatment
serum HDL cholesterol	Serum concentration of HDL cholesterol	At the baseline and following 12 weeks of treatment
serum triglycerides	Serum concentration of triglycerides	At the baseline and following 12 weeks of treatment
insulin	insulin serum concentration	At the baseline and following 12 weeks of treatment
glucose	glucose serum concentration	At the baseline and following 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Collaborators: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Joanna Suliburska, Assoc. Prof., Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: obesity; adipose tissue; Plantago major; mineral content
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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