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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger-supplemented beverage | Experimental | Daily consumption of the functional product enriched with ginger for 60 days. |
|
| Placebo beverage | Placebo Comparator | Placebo beverage matched in appearance to the intervention for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional beverage enriched with ginger | Dietary Supplement | Functional drink enriched with ginger |
|
| 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. 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Marhuenda Hernández | Contact | +34 968 278 618 | jmarhuenda@ucam.edu | |
| Universidad Católica San Antonio de Murcia | Contact | +34968278800 |
| Name | Affiliation | Role |
|---|---|---|
| JAvier Marhuenda Hernández | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM | Recruiting | Murcia | Spain |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Control beverage without ginger | Dietary Supplement | Control beverage without ginger |
|
| 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 |