The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential

May 23, 2024 updated by: Małgorzata Zujko, Medical University of Bialystok

The Impact of Chokeberry Bioproducts Consumption on Metabolic Parameters and the Antioxidant Potential of Serum

Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-089
        • Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 30-65 years,
  • low or moderate physical activity.

Exclusion Criteria:

  • age <30 and >65 years,
  • high physical activity,
  • obesity (class II),
  • diabetes (all types),
  • gastric ulcer,
  • acute or chronic gastritis,
  • intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders,
  • taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy,
  • high physical activity,
  • pregnancy,
  • breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dietary intervention with chokeberry juice and fibre
Study participants consumed 100 mL of chokeberry juice daily for 8 weeks. After 8 weeks, participants consumed 100 ml of chokeberry juice and 10 g of chokeberry fiber daily for 4 weeks.
Other: Dietary intervention with chokeberry juices
The first stage of the dietary intervention lasted 8 weeks. Study participants consumed 100 ml of chokeberry juice daily. Chokeberry juice came from ecological cultivation (Poland). Participants qualified for the study had specific biochemical parameters tested: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. Blood tests were performed in a certified external laboratory before and after 8 weeks of intervention. In addition, blood pressure and waist circumference were tested.
Other: Dietary intervention with chokeberry juices and fibers
The second stage of the dietary intervention lasted 4 weeks. Study participants consumed 100 ml of chokeberry juice daily and 10 g chokeberry fiber daily (from ecological cultivation, Poland). Blood tests were performed in a certified external laboratory after 4 weeks of intervention. The following blood tests were performed: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. In addition, blood pressure and waist circumference were tested.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in waist circumference was observed.
12 weeks
Change in blood pressure
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in systolic and diastolic blood pressure was observed.
12 weeks
Change in glycated hemoglobin
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glycated hemoglobin was observed.
12 weeks
Change in glucose level
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glucose level was observed.
12 weeks
Change in LDL-cholesterol
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in LDL-cholesterol level was observed.
12 weeks
Change in aspartate transaminase (AST) level
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in aspartate transaminase (AST) level was observed.
12 weeks
Change in antioxidant potential of serum
Time Frame: 12 weeks
After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in antioxidant potential of serum was observed.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Bialystok

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Malgorzata E. Zujko, Dr., Medical University of Bialystok

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUBialystok2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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