NCT07433998

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 19, 2026

Last Update Submit

March 2, 2026

Conditions

Inflammation BiomarkersOxidative StressCardiometabolic Risk Factors

Keywords

inflammation BiomarkersOxidative StressRandomized Controlled TrialGinger

Outcome Measures

Primary Outcomes (5)

  • 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. 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 Outcomes (10)

  • Change in total cholesterol

    Day 1 and Day 60

  • Change in LDL-cholesterol

    Day 1 and Day 60

  • Change in HDL-cholesterol

    Day 1 and Day 60

  • Change in triglycerides

    Day 1 and Day 60

  • Change in fasting plasma glucose

    Day 1 and Day 60

  • +5 more secondary outcomes

Study Arms (2)

Ginger-supplemented beverage

EXPERIMENTAL

Daily consumption of the functional product enriched with ginger for 60 days.

Dietary Supplement: Functional beverage enriched with ginger

Placebo beverage

PLACEBO COMPARATOR

Placebo beverage matched in appearance to the intervention for 60 days

Dietary Supplement: Control beverage without ginger

Interventions

Functional beverage enriched with gingerDIETARY_SUPPLEMENT

Functional drink enriched with ginger

Ginger-supplemented beverage
Control beverage without gingerDIETARY_SUPPLEMENT

Control beverage without ginger

Placebo beverage

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM

Murcia, Spain

RECRUITING

MeSH Terms

Interventions

ginger extract

Study Officials

  • JAvier Marhuenda Hernández

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Marhuenda Hernández

CONTACT

+34 968 278 618jmarhuenda@ucam.edu

Universidad Católica San Antonio de Murcia

CONTACT

+34968278800

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

March 1, 2026

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

ES(1)