Effect of Ginger Capsules on Inflammation, Oxidative Stress, and Endothelial Function

Study of the Effect of Ginger Capsules 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: Recruiting
• Conditions: Oxidative Stress; Cardiometabolic Risk Factors; Inflammation Biomarkers
• Intervention / Treatment: Dietary supplement: Ginger supplement; Dietary supplement: Placebo capsules without ginger

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Mª García Muñoz; Phone Number: +34 968 278 618; Email: amgarcia13@ucam.edu

Study Locations

• Spain
  • Murcia
    • Murcia, Murcia, Spain, 30107
      • Recruiting
      • Universidad Católica San Antonio de Murcia
      • Contact: Universidad Católica San Antonio de Murcia; Phone Number: +34968278800; Email: info@ucam.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Encapsulated ginger supplement; Daily consumption of ginger capsules for 60 days.	Dietary supplement: Ginger supplement; Daily consumption of ginger capsules for 60 days. Each capsule contains 500 mg of ginger extract. Participants will be instructed to take two capsules per day.
Placebo Comparator: Placebo capsules; Daily consumption of placebo capsules for 60 days.	Dietary supplement: Placebo capsules without ginger; Placebo capsules without ginger. The capsules do not contain ginger or any active bioactive compounds. Participants will be instructed to take two capsules per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum interleukin-1 beta (IL-1β) levels	Evaluation on differences in serum IL-1β levels	Day 1 and Day 60
Change in serum interleukin-6 (IL-6) levels	Evaluation on differences in serum IL-6 levels	Day 1 and Day 60
Change in plasma homocysteine levels	Evaluation on differences in homocysteine levels	Day 1 and Day 60
Change in plasma fibrinogen concentrations	Evaluation on differences in fibrinogen concentrations	Day 1 and Day 60
Atherogenic index	Evaluation on differences in atherogenic index	Day 1 and Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol	Evaluation on differences in total cholesterol leveles (mg/dL)	Day 1 and Day 60
Change in LDL-cholesterol	Evaluation on differences in LDL-cholesterol (mg/dL) levels	Day 1 and Day 60
Change in HDL-cholesterol	Evaluation on differences in HDL-cholesterol (mg/dL) levels	Day 1 and Day 60
Change in triglycerides	Evaluation on differences in triglycerides (mg/dL) levels	Day 1 and Day 60
Change in fasting plasma glucose	Evaluation on differences in fasting plasma glucosa (mg/dL) levels	Day 1 and Day 60
Change in body weight	Evaluation of differences in body weight (kg)	Day 1 and Day 60
Change in body mass index	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	Evaluation of differences in fat mass (%)	Day 1 and Day 60
Change in lean mass	Evaluation of differences in lean mass (%)	Day 1 and Day 60
Change in blood pressure	Measured as changes in systolic and diastolic blood pressure (mmHg)	Day 1 and Day 60

Collaborators and Investigators

• Sponsor: Ana Mª Garcia Munoz

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Oxidative Stress; Ginger; Inflammation Biomarkers
• Other Study ID Numbers: CE022406B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No