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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 |
|---|---|---|---|
| Encapsulated ginger supplement | Experimental | Daily consumption of ginger capsules for 60 days. |
|
| Placebo capsules | Placebo Comparator | Daily consumption of placebo capsules for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger supplement | Dietary 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. |
| 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 |
| 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 | |
|---|---|---|---|---|
| Ana Mª García Muñoz | Contact | +34 968 278 618 | amgarcia13@ucam.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio de Murcia | Recruiting | Murcia | Murcia | 30107 | Spain |
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| Placebo capsules without ginger | Dietary Supplement | 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. |
|
| 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 |