Effect of a Ginger-Based Beverage on Inflammation, Oxidative Stress, and Endothelial Function

March 2, 2026 updated by: Javier Marhuenda

Study of the Effect of a Ginger-based Functional Beverage on Markers of Inflammation, Oxidative Stress, and Endothelial Damage.

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Study Overview

Status

Status

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

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.

Detailed Description

The duration of the study will be 60 days, during which the investigational product or placebo will be consumed daily according to the assigned intervention. Participants will be randomly allocated to the different study arms following a double-blind design.

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 (Estimated)

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Universidad Católica San Antonio de Murcia
  • Phone Number: +34968278800

Study Contact Backup

Study Locations

  • Spain
      • Murcia, Spain
        • Recruiting
        • UCAM
        • Contact:
          • UCAM UCAM Catholic University of Murcia
          • Phone Number: 968 27 88 00
          • Email: info@ucam.edu

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:

  • Male and female participants.
  • Age between 23 and 65 years.
  • Body mass index (BMI) > 27.5 kg/m².
  • Absence of diagnosed chronic diseases.
  • Not receiving pharmacological treatment or dietary supplementation on a regular basis.
  • Ability to understand the study procedures and willingness to comply with study requirements.

Exclusion Criteria:

  • Presence of acute or chronic diseases not specified in the inclusion criteria.
  • Ongoing chronic pharmacological treatment or active use of dietary supplements.
  • Major surgery within the previous three months.
  • Current smokers or recent former smokers (less than six months since cessation).
  • History of clinically relevant food allergies or eating disorders.
  • Concurrent participation in another clinical trial or research study.
  • Pregnancy or breastfeeding.
  • Following an active weight-loss diet.
  • Investigator's judgment of unsuitability for study participation.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Ginger-supplemented beverage
Daily consumption of the functional product enriched with ginger for 60 days.
Dietary supplement: Functional beverage enriched with ginger
Functional drink enriched with ginger
Placebo Comparator: Placebo beverage
Placebo beverage matched in appearance to the intervention for 60 days
Dietary supplement: Control beverage without ginger
Control beverage without ginger

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 serum interleukin-1 beta (IL-1β) levels
Time Frame: Day 1 and Day 60
Evaluation on differences in serum IL-1β levels
Day 1 and Day 60
Change in serum interleukin-6 (IL-6) levels
Time Frame: Day 1 and Day 60
Evaluation on differences in serum IL-6 levels
Day 1 and Day 60
Change in plasma homocysteine levels
Time Frame: Day 1 and Day 60
Evaluation on differences in homocysteine levels
Day 1 and Day 60
Change in plasma fibrinogen concentrations
Time Frame: Day 1 and Day 60
Evaluation on differences in fibrinogen concentrations
Day 1 and Day 60
Atherogenic index
Time Frame: Day 1 and Day 60
Evaluation on differences in atherogenic index. Differences in the Atherogenic Index of Plasma (AIP), calculated as log (triglycerides/HDL-cholesterol), will be evaluated between the intervention and control groups. Additionally, pre-post changes in AIP will be assessed within each group.
Day 1 and Day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in total cholesterol
Time Frame: Day 1 and Day 60
Evaluation on differences in total cholesterol leveles (mg/dL)
Day 1 and Day 60
Change in LDL-cholesterol
Time Frame: Day 1 and Day 60
Evaluation on differences in LDL-cholesterol (mg/dL) levels
Day 1 and Day 60
Change in HDL-cholesterol
Time Frame: Day 1 and Day 60
Evaluation on differences in HDL-cholesterol (mg/dL) levels
Day 1 and Day 60
Change in triglycerides
Time Frame: Day 1 and Day 60
Evaluation on differences in triglycerides (mg/dL) levels
Day 1 and Day 60
Change in fasting plasma glucose
Time Frame: Day 1 and Day 60
Evaluation on differences in fasting plasma glucosa (mg/dL) levels
Day 1 and Day 60
Change in body weight
Time Frame: Day 1 and Day 60
Evaluation of differences in body weight (kg)
Day 1 and Day 60
Change in body mass index
Time Frame: Day 1 and Day 60
BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²).
Day 1 and Day 60
Change in fat mass
Time Frame: Day 1 and Day 60
Evaluation of differences in fat mass (%)
Day 1 and Day 60
Change in lean mass
Time Frame: Day 1 and Day 60
Evaluation of differences in lean mass (%)
Day 1 and Day 60
Change in blood pressure
Time Frame: Day 1 and Day 60
Measured as changes in systolic and diastolic blood pressure (mmHg)
Day 1 and Day 60

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.
Javier Marhuenda

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: JAvier Marhuenda Hernández, Universidad Católica San Antonio de Murcia

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 (Estimated)

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.
March 1, 2026

Primary Completion (Estimated)

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.
May 1, 2026

Study Completion (Estimated)

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.
June 1, 2026

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).
February 19, 2026

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.
February 19, 2026

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.
February 25, 2026

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.
March 4, 2026

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.
March 2, 2026

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.
February 1, 2026

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.
  • CE022406

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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