Clinical trial NCT03439540: Influence of Plantago Major on Mineral Metabolism and Selected Biochemical Parameters in Obese Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Plantago major
obesity
mineral content
adipose tissue
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
Collaborators: name: Poznan University of Medical Sciences
First posted: 2018-02-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: mineral content
timeFrame: At the baseline and following 12 weeks of treatment
Secondary outcomes:
measure: blood pressure
timeFrame: At the baseline and following 12 weeks of treatment
measure: body mass
timeFrame: At the baseline and following 12 weeks of treatment
measure: body height
timeFrame: At the baseline and following 12 weeks of treatment
measure: hip circumference
timeFrame: At the baseline and following 12 weeks of treatment
measure: waist circumference
timeFrame: At the baseline and following 12 weeks of treatment
measure: body content measured by bioimpedance: % of fat tissue
timeFrame: At the baseline and following 12 weeks of treatment
measure: body content measured by bioimpedance: % of muscle tissue
timeFrame: At the baseline and following 12 weeks of treatment
measure: serum total cholesterol
timeFrame: At the baseline and following 12 weeks of treatment
measure: serum LDL cholesterol
timeFrame: At the baseline and following 12 weeks of treatment
measure: serum HDL cholesterol
timeFrame: At the baseline and following 12 weeks of treatment
measure: serum triglycerides
timeFrame: At the baseline and following 12 weeks of treatment
measure: insulin
timeFrame: At the baseline and following 12 weeks of treatment
measure: glucose
timeFrame: At the baseline and following 12 weeks of treatment
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Sciences
name: Joanna Suliburska, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: