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Recruiting NCT07433998

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

No phase Interventional Inflammation Biomarkers Oxidative Stress Cardiometabolic Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional beverage enriched with ginger, Control beverage without ginger.
Who it may be relevant to
Registry conditions: Inflammation Biomarkers, Oxidative Stress, Cardiometabolic Risk Factors. Basic parameters: 23 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Dietary supplement Functional beverage enriched with ginger
    Functional drink enriched with ginger
  • Dietary supplement Control beverage without ginger
    Control beverage without ginger

Primary outcome measures

  • Change in serum interleukin-1 beta (IL-1β) levels [Time frame: Day 1 and Day 60]
  • Change in serum interleukin-6 (IL-6) levels [Time frame: Day 1 and Day 60]
  • Change in plasma homocysteine levels [Time frame: Day 1 and Day 60]
  • Change in plasma fibrinogen concentrations [Time frame: Day 1 and Day 60]
  • Atherogenic index [Time frame: Day 1 and Day 60]
Secondary outcome measures (10)
  • Change in total cholesterol [Time frame: Day 1 and Day 60]
  • Change in LDL-cholesterol [Time frame: Day 1 and Day 60]
  • Change in HDL-cholesterol [Time frame: Day 1 and Day 60]
  • Change in triglycerides [Time frame: Day 1 and Day 60]
  • Change in fasting plasma glucose [Time frame: Day 1 and Day 60]
  • Change in body weight [Time frame: Day 1 and Day 60]
  • Change in body mass index [Time frame: Day 1 and Day 60]
  • Change in fat mass [Time frame: Day 1 and Day 60]
  • Change in lean mass [Time frame: Day 1 and Day 60]
  • Change in blood pressure [Time frame: Day 1 and Day 60]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • UCAM — Murcia

Identifiers

NCT: NCT07433998 · CE022406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗