Inflammation Biomarkers, Oxidative Stress, Cardiometabolic Risk Factors
Conditions
Keywords
Inflammation Biomarkers, Oxidative Stress, Randomized Controlled Trial, Ginger
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.
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_SUPPLEMENTGinger 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.
DIETARY_SUPPLEMENTPlacebo 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.
Sponsors
Ana Mª Garcia Munoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum interleukin-1 beta (IL-1β) levels | Day 1 and Day 60 | Evaluation on differences in serum IL-1β levels |
| Change in serum interleukin-6 (IL-6) levels | Day 1 and Day 60 | Evaluation on differences in serum IL-6 levels |
| Change in plasma homocysteine levels | Day 1 and Day 60 | Evaluation on differences in homocysteine levels |
| Change in plasma fibrinogen concentrations | Day 1 and Day 60 | Evaluation on differences in fibrinogen concentrations |
| Atherogenic index | Day 1 and Day 60 | Evaluation on differences in atherogenic index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol | Day 1 and Day 60 | Evaluation on differences in total cholesterol leveles (mg/dL) |
| Change in LDL-cholesterol | Day 1 and Day 60 | Evaluation on differences in LDL-cholesterol (mg/dL) levels |
| Change in HDL-cholesterol | Day 1 and Day 60 | Evaluation on differences in HDL-cholesterol (mg/dL) levels |
| Change in triglycerides | Day 1 and Day 60 | Evaluation on differences in triglycerides (mg/dL) levels |
| Change in fasting plasma glucose | Day 1 and Day 60 | Evaluation on differences in fasting plasma glucosa (mg/dL) levels |
| Change in body weight | Day 1 and Day 60 | Evaluation of differences in body weight (kg) |
| Change in body mass index | Day 1 and Day 60 | BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²). |
| Change in fat mass | Day 1 and Day 60 | Evaluation of differences in fat mass (%) |
| Change in lean mass | Day 1 and Day 60 | Evaluation of differences in lean mass (%) |
| Change in blood pressure | Day 1 and Day 60 | Measured as changes in systolic and diastolic blood pressure (mmHg) |
Countries
Spain
Contacts
CONTACTAna Mª García Muñoz
Outcome results
None listed