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

Poznan University of Life Sciences

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Plantago major

Study type

Interventional

Funder types

Other

Identifiers

NCT03439540

1104/16

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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