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NCT Number: NCT07433998

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

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.

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Key information

Conditions

Inflammation Biomarkers Cardiometabolic Risk Factors Oxidative Stress

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional beverage enriched with ginger

Dietary Supplement

Functional drink enriched with ginger

Control beverage without ginger

Dietary Supplement

Control beverage without ginger

Primary outcomes

  1. Change in serum interleukin-1 beta (IL-1β) levels

    Time frame: Day 1 and Day 60

    Evaluation on differences in serum IL-1β levels

  2. Change in serum interleukin-6 (IL-6) levels

    Time frame: Day 1 and Day 60

    Evaluation on differences in serum IL-6 levels

  3. Change in plasma homocysteine levels

    Time frame: Day 1 and Day 60

    Evaluation on differences in homocysteine levels

  4. Change in plasma fibrinogen concentrations

    Time frame: Day 1 and Day 60

    Evaluation on differences in fibrinogen concentrations

  5. 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.

Secondary outcomes

  1. Change in total cholesterol

    Time frame: Day 1 and Day 60

    Evaluation on differences in total cholesterol leveles (mg/dL)

  2. Change in LDL-cholesterol

    Time frame: Day 1 and Day 60

    Evaluation on differences in LDL-cholesterol (mg/dL) levels

  3. Change in HDL-cholesterol

    Time frame: Day 1 and Day 60

    Evaluation on differences in HDL-cholesterol (mg/dL) levels

  4. Change in triglycerides

    Time frame: Day 1 and Day 60

    Evaluation on differences in triglycerides (mg/dL) levels

  5. Change in fasting plasma glucose

    Time frame: Day 1 and Day 60

    Evaluation on differences in fasting plasma glucosa (mg/dL) levels

  6. Change in body weight

    Time frame: Day 1 and Day 60

    Evaluation of differences in body weight (kg)

  7. 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).

  8. Change in fat mass

    Time frame: Day 1 and Day 60

    Evaluation of differences in fat mass (%)

  9. Change in lean mass

    Time frame: Day 1 and Day 60

    Evaluation of differences in lean mass (%)

  10. Change in blood pressure

    Time frame: Day 1 and Day 60

    Measured as changes in systolic and diastolic blood pressure (mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Marhuenda Hernández

CONTACT

[email protected]

+34 968 278 618

Universidad Católica San Antonio de Murcia

CONTACT

+34968278800

Sponsors and collaborators

Lead sponsor

Javier Marhuenda

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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