Effect of oral supplementation with Plantago major on cardiometabolic risk factors and mineral content and lifestyle in obese women: double-blind, randomized clinical trial.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
70
Individuals receive Plantago major daily, for 12 weeks
Individuals receive placebo daily, for 12 weeks
Poznan University of Life Sciences
Poznan, Poland
mineral content
content of minerals in serum, urine and hair
Time frame: At the baseline and following 12 weeks of treatment
blood pressure
blood pressure
Time frame: At the baseline and following 12 weeks of treatment
body mass
body mass
Time frame: At the baseline and following 12 weeks of treatment
body height
body height
Time frame: At the baseline and following 12 weeks of treatment
hip circumference
hip circumference
Time frame: At the baseline and following 12 weeks of treatment
waist circumference
waist circumference
Time frame: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of fat tissue
Content of fat tissue measured by bioimpedance
Time frame: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of muscle tissue
Content of muscle tissue measured by bioimpedance
Time frame: At the baseline and following 12 weeks of treatment
serum total cholesterol
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Serum concentration of total cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum LDL cholesterol
Serum concentration of LDL cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum HDL cholesterol
Serum concentration of HDL cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum triglycerides
Serum concentration of triglycerides
Time frame: At the baseline and following 12 weeks of treatment
insulin
insulin serum concentration
Time frame: At the baseline and following 12 weeks of treatment
glucose
glucose serum concentration
Time frame: At the baseline and following 12 weeks of treatment