ObesityPlantagoNCT03439540
Influence of Plantago Major on Mineral Metabolism and Selected Biochemical Parameters in Obese Women
A study testing Plantago major in people with Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Plantago major
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Effect of oral supplementation with Plantago major on cardiometabolic risk factors and mineral content and lifestyle in obese women: double-blind, randomized clinical trial.
Read the 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.
- Conditions
- Obesity
- Being tested
- Plantago major, Placebo
- Keywords
- Plantago major, obesity, mineral content, adipose tissue
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantago majorDietary supplement
Individuals receive Plantago major daily, for 12 weeks
PlaceboDietary supplement
Individuals receive placebo daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Individuals receive a placebo daily, for 12 weeks. Receives: Dietary Supplement: Placebo |
| Plantago major | Experimental | Individuals receive Plantago major daily, for 12 weeks. Receives: Dietary Supplement: Plantago major |
What is being measured
The primary outcome is the main question the study is designed to answer.
mineral content
content of minerals in serum, urine and hair
Measured: At the baseline and following 12 weeks of treatment
Secondary outcomes (13)
blood pressure
blood pressure
Measured: At the baseline and following 12 weeks of treatment
body mass
body mass
Measured: At the baseline and following 12 weeks of treatment
body height
body height
Measured: At the baseline and following 12 weeks of treatment
hip circumference
hip circumference
Measured: At the baseline and following 12 weeks of treatment
waist circumference
waist circumference
Measured: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of fat tissue
Content of fat tissue measured by bioimpedance
Measured: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of muscle tissue
Content of muscle tissue measured by bioimpedance
Measured: At the baseline and following 12 weeks of treatment
serum total cholesterol
Serum concentration of total cholesterol
Measured: At the baseline and following 12 weeks of treatment
serum LDL cholesterol
Serum concentration of LDL cholesterol
Measured: At the baseline and following 12 weeks of treatment
serum HDL cholesterol
Serum concentration of HDL cholesterol
Measured: At the baseline and following 12 weeks of treatment
serum triglycerides
Serum concentration of triglycerides
Measured: At the baseline and following 12 weeks of treatment
insulin
insulin serum concentration
Measured: At the baseline and following 12 weeks of treatment
glucose
glucose serum concentration
Measured: At the baseline and following 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Dec 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Joanna Suliburska, Poznan University of Life Sciences
- Investigators
- Joanna Suliburska, Assoc. Prof., Principal investigator, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439540
- Sponsor's protocol ID
- 1104/16
- Acronym
- Plantago
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03439540
- Acronym / sponsor ID
- Plantago / 1104/16
- Conditions
- Obesity
- Keywords
- Plantago major, obesity, mineral content, adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIndividuals receive a placebo daily, for 12 weeks. |
| Plantago major | Experimental | Dietary Supplement: Plantago majorIndividuals receive Plantago major daily, for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- body mass index (BMI) equal to or greater than 30 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plantago majorIndividuals receive Plantago major daily, for 12 weeks | Dietary supplement | Plantago major |
| PlaceboIndividuals receive placebo daily, for 12 weeks | Dietary supplement | Placebo |
Primary outcome
mineral content
Time frame: At the baseline and following 12 weeks of treatment
content of minerals in serum, urine and hair
13 secondary outcomes
blood pressure
Time frame: At the baseline and following 12 weeks of treatment
body mass
Time frame: At the baseline and following 12 weeks of treatment
body height
Time frame: At the baseline and following 12 weeks of treatment
hip circumference
Time frame: At the baseline and following 12 weeks of treatment
waist circumference
Time frame: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of fat tissue
Time frame: At the baseline and following 12 weeks of treatment
body content measured by bioimpedance: % of muscle tissue
Time frame: At the baseline and following 12 weeks of treatment
serum total cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum LDL cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum HDL cholesterol
Time frame: At the baseline and following 12 weeks of treatment
serum triglycerides
Time frame: At the baseline and following 12 weeks of treatment
insulin
Time frame: At the baseline and following 12 weeks of treatment
glucose
Time frame: At the baseline and following 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Suliburska, Assoc. Prof. principal investigator
Poznan University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantago major in people with Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mineral content (time frame: At the baseline and following 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.