NCT03439540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

February 13, 2018

Last Update Submit

April 4, 2022

Conditions

Obesity

Keywords

Plantago majorobesitymineral contentadipose tissue

Outcome Measures

Primary Outcomes (1)

  • mineral content

    content of minerals in serum, urine and hair

    At the baseline and following 12 weeks of treatment

Secondary Outcomes (13)

  • blood pressure

    At the baseline and following 12 weeks of treatment

  • body mass

    At the baseline and following 12 weeks of treatment

  • body height

    At the baseline and following 12 weeks of treatment

  • hip circumference

    At the baseline and following 12 weeks of treatment

  • waist circumference

    At the baseline and following 12 weeks of treatment

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Individuals receive a placebo daily, for 12 weeks.

Dietary Supplement: Placebo

Plantago major

EXPERIMENTAL

Individuals receive Plantago major daily, for 12 weeks.

Dietary Supplement: Plantago major

Interventions

Plantago majorDIETARY_SUPPLEMENT

Individuals receive Plantago major daily, for 12 weeks

Plantago major
PlaceboDIETARY_SUPPLEMENT

Individuals receive placebo daily, for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

Location

MeSH Terms

Conditions

Obesity

Interventions

sucrose transport protein, plant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joanna Suliburska, Assoc. Prof.

    Poznan University of Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assiastant professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

March 1, 2018

Primary Completion

December 1, 2020

Study Completion

September 30, 2021

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations

PL(1)