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

Obesity Clinical Trial

— Plantago  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439540
• Other study ID #: 1104/16
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: Poznan University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 30, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Plantago major
Individuals receive Plantago major daily, for 12 weeks
• Placebo
Individuals receive placebo daily, for 12 weeks

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Life Sciences	Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mineral content	content of minerals in serum, urine and hair	At the baseline and following 12 weeks of treatment
Secondary	blood pressure	blood pressure	At the baseline and following 12 weeks of treatment
Secondary	body mass	body mass	At the baseline and following 12 weeks of treatment
Secondary	body height	body height	At the baseline and following 12 weeks of treatment
Secondary	hip circumference	hip circumference	At the baseline and following 12 weeks of treatment
Secondary	waist circumference	waist circumference	At the baseline and following 12 weeks of treatment
Secondary	body content measured by bioimpedance: % of fat tissue	Content of fat tissue measured by bioimpedance	At the baseline and following 12 weeks of treatment
Secondary	body content measured by bioimpedance: % of muscle tissue	Content of muscle tissue measured by bioimpedance	At the baseline and following 12 weeks of treatment
Secondary	serum total cholesterol	Serum concentration of total cholesterol	At the baseline and following 12 weeks of treatment
Secondary	serum LDL cholesterol	Serum concentration of LDL cholesterol	At the baseline and following 12 weeks of treatment
Secondary	serum HDL cholesterol	Serum concentration of HDL cholesterol	At the baseline and following 12 weeks of treatment
Secondary	serum triglycerides	Serum concentration of triglycerides	At the baseline and following 12 weeks of treatment
Secondary	insulin	insulin serum concentration	At the baseline and following 12 weeks of treatment
Secondary	glucose	glucose serum concentration	At the baseline and following 12 weeks of treatment