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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Plantago major
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Individuals receive a placebo daily, for 12 weeks. | Dietary Supplement: Placebo<br>* Individuals receive placebo daily, for 12 weeks<br>|
| Experimental: Plantago major<br>Individuals receive Plantago major daily, for 12 weeks. | Dietary Supplement: Plantago major<br>* Individuals receive Plantago major daily, for 12 weeks<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plantago major, obesity, mineral content, adipose tissue