Effect of Ginger Capsules on Inflammation, Oxidative Stress, and Endothelial Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-65
SponsorAna Mª Garcia Munoz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants.
Age between 23 and 65 years.
Body mass index (BMI) > 27.5 kg/m².
Absence of diagnosed chronic diseases.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Ginger supplement
Dietary supplementDaily 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 capsules without ginger
Dietary supplementPlacebo capsules without ginger. The capsules do not contain ginger or any active bioactive compounds. Participants will be instructed to take two capsules per day.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Encapsulated ginger supplementExperimental treatment 1 intervention
Group B: Placebo capsulesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in serum interleukin-1 beta (IL-1β) levels
Evaluation on differences in serum IL-1β levels
Time frame
Day 1 and Day 602
Change in serum interleukin-6 (IL-6) levels
Evaluation on differences in serum IL-6 levels
Time frame
Day 1 and Day 603
Change in plasma homocysteine levels
Evaluation on differences in homocysteine levels
Time frame
Day 1 and Day 604
Change in plasma fibrinogen concentrations
Evaluation on differences in fibrinogen concentrations
Time frame
Day 1 and Day 60Secondary outcomes
1
Change in total cholesterol
Evaluation on differences in total cholesterol leveles (mg/dL)
Time frame
Day 1 and Day 602
Change in LDL-cholesterol
Evaluation on differences in LDL-cholesterol (mg/dL) levels
Time frame
Day 1 and Day 603
Change in HDL-cholesterol
Evaluation on differences in HDL-cholesterol (mg/dL) levels
Time frame
Day 1 and Day 604
Change in triglycerides
Evaluation on differences in triglycerides (mg/dL) levels
Time frame
Day 1 and Day 60Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ana Mª Garcia Munoz
Lead sponsor
Universidad Católica San Antonio de Murcia
Sponsor institution
Source ClinicalTrials.gov