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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Plantago major; Dietary Supplement: Placebo

• Registration Number: NCT03439540
• Lead Sponsor: Poznan University of Life Sciences

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.

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2018-03-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plantago major	Plantago major	Individuals receive Plantago major daily, for 12 weeks.
Placebo	Placebo	Individuals receive a placebo daily, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
mineral content	At the baseline and following 12 weeks of treatment	content of minerals in serum, urine and hair

Secondary Outcome Measures

Name	Time	Method
blood pressure	At the baseline and following 12 weeks of treatment	blood pressure
body mass	At the baseline and following 12 weeks of treatment	body mass
waist circumference	At the baseline and following 12 weeks of treatment	waist circumference
body content measured by bioimpedance: % of muscle tissue	At the baseline and following 12 weeks of treatment	Content of muscle tissue measured by bioimpedance
serum LDL cholesterol	At the baseline and following 12 weeks of treatment	Serum concentration of LDL cholesterol
body height	At the baseline and following 12 weeks of treatment	body height
hip circumference	At the baseline and following 12 weeks of treatment	hip circumference
insulin	At the baseline and following 12 weeks of treatment	insulin serum concentration
body content measured by bioimpedance: % of fat tissue	At the baseline and following 12 weeks of treatment	Content of fat tissue measured by bioimpedance
serum total cholesterol	At the baseline and following 12 weeks of treatment	Serum concentration of total cholesterol
serum HDL cholesterol	At the baseline and following 12 weeks of treatment	Serum concentration of HDL cholesterol
glucose	At the baseline and following 12 weeks of treatment	glucose serum concentration
serum triglycerides	At the baseline and following 12 weeks of treatment	Serum concentration of triglycerides

Trial Locations

Locations (1)

Poznan University of Life Sciences; 🇵🇱 Poznań, Poland